Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **************** .
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
**Purpose and Scope:**
Member of cross-functional teams, the primary purpose of the Associate Director is to act independently as Lead Safety Statistician (LSS) / Medical Affairs Statistician (MA) / Exploratory Statistician / Regional Statistician Lead (RSTATL) or Lead Product Statistician (LPS) for complex/novel work in an established area (safety/clinical/ observational studies, MA tactic, Biomarker & PK/PD Analyses or local project), This position may also act as Global Statistical Lead (GSTATL) for an early or back up asset or as a Methodology expert validating the execution of complex techniques.
The position is expected to complete these tasks with minimal supervision from the GSTATL, LPS or the Primary Focus Statistics Lead (PFSL). Under the supervision of an experienced statistician, the position can act as global safety statistical lead for a late phase or novel asset or represent Astellas on statistical matters related to safety data, clinical data, Biomarkers, PK/PD, PROs, or methodology at meetings with regulatory authorities, key opinion leaders and HTAs. The position may also research innovative solutions and train other statisticians.
**Essential Job Responsibilities:**
Provides best in class safety data science and statistical support to the asset level for Astellas drug development programs. For assigned projects, provides all required safety statistical support and deliverables by supervising another statistician, or as a member of study team.
+ Ensures quality and consistency of key safety data science deliverables.
+ Accountable for the Asset Level Safety Assessment Plan (ALSAP).
+ For early or non complex asset, independently provides strategic safety statistical input to the asset teams (for example, CDP, CMP, go/no go approach, OCs ) including design of studies and analyses requiring advanced statistical methodologies.
+ Executes biomarker and PK/PD strategies, leads large/complex studies or supports marketed products for a safety purpose.
+ Contributes to regulatory and payer dossiers and publications - provides statistical interpretation of the results.
+ Presents summary data and analyses to key stakeholders in a compelling and clear manner
+ Ensures availability of safety-related data, biomarker, external data, CRF integrated database(s) where needed, and planning and conduct of integrated analyses to support development decisions, submissions or marketing needs.
+ May participate in due diligence activities, reviews safety data and advises company
+ Is responsible to implement, explain and validate complex safety statistical methodology
**Personal Development / Collaboration**
+ Recognizes and addresses issues which may impact the statistical integrity of the development program or for which novel statistical methodology may add value
+ Contributes to cross-functional or indication level improvement initiatives (i.e write SOP - select, validate and implement statistical software - standard output generation - creation of, maintenance and adherence to indication specific standards - selection and qualification/audits of vendors)
+ Contributes to the recruitment, training, professional development and retention of statistical personnel.
+ is a member of external industry or professional organizations, developing relations with leading academic institutions, advising internally on innovative Statistical methods or checking their correct implementation.
**Qualifications:**
**Required**
+ PhD or M.S in Biostatistics, Statistics or related scientific field
+ 6+ years (9+ years for MS) of experience in applying statistical methods in biomedical research, Pharma, CRO, Academia or Healthcare industry or in providing statistical direction in these areas
+ Advanced and broad knowledge of statistical methods, along with understanding of industry practices related to the statistical analysis of clinical and biomarker data
+ Knowledge and skills in SAS required, knowledge of R preferred.
+ In-depth familiarity with processes and procedures in data management and programming
+ Experience working in an international environment
+ Experience in safety data analysis and risk management activities (e.g., ALSAP, DSUR, RMP, signal detection) at the asset level.
+ Good knowledge of medical literature, clinical, regulatory and commercial landscape
+ Ability to understand, implement, and explain complex statistical methodology.
**Salary Range:**
$141,400 - $222,200 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Company fleet vehicle for eligible positions
+ Referral bonus program
\#LI-SS
Category Quantitative Sciences & Evidence Generation
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
#LI-Remote This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require 50% travel.
Novartis is unable to offer relocation support for this role: please only apply if this location is accessible to you.
Company will not sponsor visas for this position.
The ExecutiveDirector of Future Go-to-Market (GTM) Transformation leads the vision and activation of Novartis' next-generation Go-to-Market engagement model. This role guides a dynamic team of Directors, each driving a key workstream - from customer targeting and engagement to field role design and future capabilities. Together, they shape a unified, customer-centered approach that aligns with brand priorities and commercial goals across therapeutic areas. As the central connector, this leader fosters collaboration, governance, and innovation to bring future-ready Go-to-Market strategies to life.
Job Description
Key Responsibilities:
Design the future-state Go-to-Market (GTM) model for Novartis, ensuring it reflects customer-centric thinking, system-wide integration, and alignment across all therapeutic areas.
Turn strategic vision into clear, scalable action plans across five transformation domains: customer targeting, engagement models, field role design, capabilities, and metrics.
Align Go-to-Market transformation efforts with brand strategy, therapeutic area goals, U.S. commercial priorities, and customer engagement objectives.
Lead and support five Director-level workstream leaders, fostering clarity, ownership, and collaboration across initiatives.
Build strong governance practices, track milestones, and ensure seamless cross-functional coordination.
Collaborate with senior leaders in Medical, Market Access, Marketing, People & Organization, and Strategy to co-create and embed transformation efforts.
Represent Go-to-Market transformation in enterprise-wide forums, promoting transparency and connection between field teams and headquarters.
Engage stakeholders across the organization to build understanding, drive adoption, and sustain momentum for change.
Guide the development, testing, and scaling of new Go-to-Market models that respond to evolving market needs and customer expectations.
Inspire a culture of innovation, teamwork, and customer focus - encouraging bold ideas and breakthrough results.
Essential Requirements:
Bachelor's degree required from 4-year college or university.
10+ years' experience in life sciences, healthcare, technology, or other complex business-to-business (B2B) industries.
Deep knowledge of commercial strategy, enterprise transformation, or Go-to-Market (GTM) design.
Proven ability to attract, grow, and retain diverse talent while building high-performing, inclusive teams.
Strong cross-functional leadership and collaboration skills across varied teams and stakeholders.
Strategic thinker with sharp analytical skills and experience leading major initiatives and managing budgets.
Successful track record of driving changes in matrixed, regulated environments with solid operational and financial acumen.
Desirable Requirements:
MBA degree, with experience in regulated or complex business-to-business (B2B) industries such as but not limited to pharmaceuticals, biotechnology, technology, financial services, or consulting.
Familiarity with agile methodologies, transformation frameworks, and enterprise planning tools that support scalable change.
Novartis Compensation Summary:
The salary for this position is expected to range between $204,400 and $379,600 per year.
The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.
Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call *************** and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range
$225,400.00 - $418,600.00
Skills Desired
Business Performance Management, Coaching, Corrective Action Plans (Cap), Customer Experience, Delegation, Finance, Front-End Development, Inside Sales (Telemarketing), Sales Enablement, Sales Management, Sales Operations, Secops (Security Operations)
$225.4k-418.6k yearly Auto-Apply 17d ago
Executive Director, Field Skills & Capability-Development-Remote
Novartis 4.9
Remote
This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager.
The ExecutiveDirector, Skills & Capability Development, is a strategic and transformative leader responsible for building and leading the capability development strategy that elevates the performance of the entire Novartis Field Force organization. Focusing on cross-functional roles and forward-thinking go-to-market models, this role will ensure the Novartis field members have the current and future skills needed to succeed in our industry. He/she will inspire, lead, and develop a high-performing team in a dynamic and complex market. He/she will support key strategic objectives of key field leaders across the sales, patient support, medical, access, and marketing field teams.
Job Description
Major Responsibilities:
Oversee the design, delivery, and measurement of strategic capability development plans that address critical organizational knowledge and skills to enhance field force impact.
Drive principles of educational excellence across his/her team to achieve the organization's commitment to exceptional customer engagement
Leads and is viewed as a strategic thought partner to the business for skill development and capability enhancement
Leverages significant market, competitor, industry, and cross-functional business knowledge to foresee and manage potential business challenges and opportunities
Influences overall business strategy and decisions within own department and with key stakeholders and drives business impact by constantly aligning with business' top and bottom-line objectives.
Consults partners and peers on key industry and leading practices and help solve complex issues and provide strategic direction by keeping a perspective and balance on external and internal view.
Makes strategic investments by allocating resources according to departmental and organizational priorities.
Defines new ways to leverage the organization's resources to support the needs of the business.
Role Expectations:
A successful ExecutiveDirector models the way for all associates by inspiring a shared vision, communicating clear expectations, promoting an environment of accountability, enabling others to act, and optimizing or advancing processes by challenging the status quo. Other key responsibilities for the ED include the following:
Accountable for all Customer Engagement Skills (non-leadership) development curriculum.
Strategically defines separate Functional and Transformational (future) curriculum strategies that align to the field organization's Engagement vision.
Owns a well-developed sense of evolving L&D trends and standards, and appropriately applies them.
Plays a leadership role on the extended team that determines the future skillsets engaging personnel will need in the future.
Identifies and implements novel methods for insuring skill obtainment is occurring on the job; defines skill obtainment metrics and analytics.
Leads a skill development team of Directors/Associate Directors/Managers, ensuring all skills training is aligned to high impact curriculum and learning transfer processes.
Responsible for administrative management of the Skills Training team (i.e. budgets, capital, headcount) as well as the performance management of assigned Directors/Associate Directors/Managers (i.e. goals, objectives, and appraisals). Manages the administration of the assigned budget.
Strategically partners with key ExecutiveDirectors within the training function (i.e., Leadership Excellence, Product Training, Operations) to ensure an integrated and holistic approach to increasing skill development & learning engagement.
Leads as a change agent, constantly seeking and defining novel ways to improve coordination, efficiency, and impact success of skills training.
Collaborates across different regions/global functions to share/obtain best practices and industry-leading approaches to skills training.
Constantly assesses opportunities to gain performance, operational, and financial efficiencies.
Build internal and/or external networks to enhance talent replacement processes for the Skills Training team.
Build a deep understanding of internal customers and key stakeholders and use the knowledge to design learning strategies that drive field performance.
Ability to embrace and instill test-and-learn mind-set in order to implement, learn, and iterate with speed and agility.
Determine the level of resources required to execute skill development strategies as part of the budgeting process.
Allocate budgeted resources to meet regional sales targets, improve ROI, and adjust according to identified opportunities and risks through the fiscal year.
Provide strong leadership and direction to maximize coaching capabilities of people leaders.
Build a best-in-class diverse Customer Experience team through talent acquisition, succession planning and development of associates.
Create inclusive and patient-focused culture built on Novartis Values & Behaviors. Ensure full team alignment to and ownership of Code of Conduct and all Legal, Ethics and Compliance Policies.
Leadership & Functional Responsibilities:
Deep understanding of and ability to collaborate and adapt to multiple stakeholders with diverse thinking to meet business needs.
Proven ability to build alignment and influence.
Ability to lead through change and ambiguity.
Comfort with decisiveness and risk taking; has ability to manage through a crisis.
Excellent interpersonal communication and presentation skills with the ability to interface seamlessly with other parts of the organization.
A strong leader who can serve as a role model for the organization; outstanding interpersonal skills; a track record in successfully fostering teamwork and developing team members; collaborative style.
Motivates and inspires others to do their best.
Leads with an enterprise hat and makes strategic decisions for the Business Unit.
High intellect: creativity, a willingness to think outside the box to create positive change.
Emotional maturity: self-confidence, ability to manage effectively in the changing, complex organizational structure.
Ability to advance to roles of greater potential.
Unquestionable ethics, values, and professional integrity.
Attributes for Success:
Customer Centric - No matter what stakeholder or customer we're working with we put the patient first. We listen to their stories and walk in their shoes We understand what they want from us. We are problem solvers; we anchor our work in customer insights, and we pivot to meet their needs.
Experimenter - To be a self-adapting business, we can no longer take linear paths. Instead, we make dynamic plans and take iterative approaches. We go beyond the first set of ideas and bring in outside inspiration. We are vulnerable and have a safe environment to engage in trial and error. We have the confidence to learn from our mistakes and support others who do the same.
Agile Learner - Change is how we thrive and to thrive we are willing to change ourselves. We know ourselves or ask for feedback to keep learning. We have a growth mindset and adapt to stay relevant. We are open about sharing our successes and failures to help others learn along the way.
Co-Creator - In an agile organization, teams are no longer bound by job titles or organizational structure Instead, we bring together the right people, those who have the right expertise or acumen, to create something new or solve problems for patients and customers. We innovate by collaborating. We integrate by collaborating. We deliver by collaborating.
Enterprise Thinker - As we work in more agile and connected ways, it's important to understand the Novartis ecosystem and interdependencies. To do this, we understand the big picture, connect the dots, see where individual pieces fit into the value chain and think across, over, up and down. We think about tradeoffs and take an enterprise approach that can be scaled and adapted for the last mile.
Decisive - To be agile, decision making needs to devolve. We trust and empower people to make smart decisions We bring the right people to the table and step out when we're not needed. We have decisive conversations and are clear on who is going to make the decision We minimize bureaucracy and move decisions to action.
Accountable Contributor - The work we do on behalf of patients requires everyone to contribute. We need to know what we're accountable for, have clarity on the ‘why' and the ‘what' and own the outcome. At all levels, to have a passion for excellence, and drive results while our managers enable us and help us measure our impact.
Deep Expert - Personal acumen underpins all of what we do for our patients and customers. We bring our deep domain expertise and specialized insights into innovative plans, internal and external conversations, and collaborative work. While we are not bound by our expertise, we know that it's important to continually replenish our expertise so we can contribute to our collective success.
Role Requirements:
Bachelor's degree required from 4-year college or university; advanced degree preferred (i.e., Curriculum Design, Behavioral Science, Organization Psychology)
Minimum 10 years of experience in leading a skills development function or larger Commercial Training/Learning organization.
Department design
Budgeting
Needs identification at a business/national scale
Business partnership with senior organizational leaders
Minimum 5 years direct manager experience.
Strong understanding of the skills “marketplace”, especially how key business skills are identified and woven into curriculum development.
Strong relationships with leadership-focused training providers/vendors.
Deep expertise in adult learning models, measurement standards, and curriculum design.
Proven self-starter with high standards of excellence and an innovative mind
Demonstrated success as an innovator with proven track record of leading ideas from concept to execution
Demonstrated leadership and expertise in building an organization
Demonstrated leadership skills; decision maker, effective problem solver; strategic thinker. Strong interpersonal, communication, influencing and analytical skills
Demonstrated ability to synthesize information to develop recommendations, and ability to persuade / influence organization pursuit of recommended path
Ability to manage multiple projects and consistently meet deadlines
Excels at interacting with a diverse group of people, all levels of management, including senior leadership
COVID-19 Vaccine Policy (customer-facing roles only): While Novartis does not require vaccination for COVID-19 or proof of a recent negative test result for COVID-19 at this time, employees working in customer-facing roles must adhere to and comply with customers' (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to **********************************.
Novartis Compensation Summary:
The salary for this position is expected to range between $204,400.00 and $379.600.00 per year.
The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.
Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call *************** and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range
$204,400.00 - $379,600.00
Skills Desired
Cad (Computer-Aided Design), Customer Requirements, Customer Service, E-Learning, Installations (Computer Programs), Leadership, Merchandising, Physics, Relationship Building, Retail Loss Prevention, Sales, Selling Skills
Band
Level 7 #LI-Remote This is a field-based and remote opportunity. Novartis is unable to offer relocation support for this role. Please only apply if this location is accessible for you. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require 60-80% travel.
The ExecutiveDirector (ED), Access & Reimbursement is a remote-based role that serves as a national leader for regionally aligned, Novartis Disease Area Access & Reimbursement field teams. The ED is responsible for co-creating field execution and pull through strategies based on the overarching business strategy and is ultimately accountable for delivering high, pre-defined business impact for the Novartis Pharmaceutical Corporation (NPC). The ED will advocate and motivate regions to deliver consistent acceleration of aligned business objectives and impact, while consistently demonstrating openness for courageous conversations and performance management of their direct reports to enable and bolster a culture-forward team mindset. The ED should continually monitor sentiment on Novartis Patient Support (NPS)-related customer experience and seek to improve by closely partnering with relevant field and headquarter-based associates.
Job Description
Key Responsibilities:
Attract, coach and retain team of high performing Regional Directors and Access & Reimbursement professionals.
Effectively translate pre-specified national strategy to a regional level to enable appropriate exquisite execution and pull through within your team. Motivate each region to align on national strategy and key business impact metrics.
Continuously monitor field team operations and seek to identify opportunities to improve efficiencies and effectiveness at a regional and national level.
Partner closely with Customer Engagement Team to ensure strong collaboration and coordination of field associate activities, business plans, and customer resolutions.
Integrate with Novartis leadership and collaborate across multi-functional teams (Sales, Marketing, Managed Markets, Operations, Training, Legal, Compliance, etc.) to ensure collaborative and compliant approach to support field success.
Understand specifics of, and resolve questions associated with, practice and/or patient reimbursement to support on any issues with third party payers.
Identify opportunities to complement NPC capabilities to strengthen the ability for patients to have access to therapy.
Collaborate with NPS Analytics to design reports and tools to monitor and achieve pre-specified business objective and aligned impact metrics.
In addition to national team leadership and accountabilities on team performance, there will be functional leadership requirements to drive impact across the broader cross-portfolio of NPS Access & Reimbursement Teams (i.e., National Payer accountabilities, Specialty Pharmacy accountabilities, field systems and tools, training and team development, culture, compliance etc.).
Maintain a deep understanding of NPC policies and requirements and perform all responsibilities with integrity and in a manner consistent with company guidance and prescribed Values and Behaviors. Handle Patient Identifiable Information (PII) appropriately (understand and ensure compliance with HIPAA and other privacy laws and regulations and internal Company compliance guidelines). This comes with the added accountability of ensure your teams are also adhering to NPC policies.
Responsible for identifying and reporting adverse events via the established Novartis systems as per applicable processes.
Essential Requirements:
Education: Minimum of a Bachelor's degree; Advanced degree preferred (Majors preferred: Sciences, Business, Pharmacy, and Healthcare)
Minimum of 10 years in reimbursement, contract strategy (if applicable), managed care, sales/marketing or related field. At least 5 years leading a regional or local team and managing and collaborating across multiple stakeholders
Experience working with highly complex practices and/or health systems to establish access and acquisition pathways
Strategic account management experience using a proactive approach to anticipate access hurdles impacting accounts and patient access.
Deep expertise and experience integrating manufacturer-sponsored patient support programs
General knowledge of reimbursement pathways (specialty pharmacy, buy-and-bill, retail)
Experience with specialty products acquired through specialty pharmacy networks and through buy-and-bill process, including expertise in acquisition, billing and coding, claims processing, and reimbursement
Possess a strong understanding of Commercial payers, Medicare plans and state Medicaid in geographic region
Proven track record building, and motivating teams. Past success in execution of launch strategies and plans
Ability to travel 60-80% over a broad geography is required, with the ability to drive and/or fly within the territory. Must have a valid driver's license
Desirable Requirements:
Complex/rare disease experience preferred (nuclear medicine, CAR T, AAV gene therapy, etc.)
Novartis Compensation Summary:
The salary for this position is expected to range between $248,500 and $461,500 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
Driving is an Essential Function of this Role: Meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving.
COVID-19 Vaccine Policy (customer-facing roles only): While Novartis does not require vaccination for COVID-19 or proof of a recent negative test result for COVID-19 at this time, employees working in customer-facing roles must adhere to and comply with customers' (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to **********************************
The individual hired for this role will be required to successfully complete certain initial training, including home study, eight (8) or fewer hours per day and forty (40) or fewer hours per week.
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to ************************ call **************** and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
***************************************************************************************
Salary Range
$248,500.00 - $461,500.00
Skills Desired
Agility, Agility, Cross-Functional Collaboration, Customer-Centric Mindset, Employee Development, Finance, Go-To-Market Strategy, Healthcare Sector Understanding, Health Economics, Health Policy, Health Technology Assessment (HTA), Influencing Skills, Innovation, Inspirational Leadership, Lcm Strategy, Market Access Strategy, Negotiation Skills, People Management, Pricing Strategy, Process Management, Product Launches, Public Affairs, Real World Evidence (RWE), Regulatory Compliance, Resource Allocation {+ 6 more}
#LI-Remote This is a field-based and remote opportunity supporting key accounts in an assigned geography. Novartis is unable to offer relocation support for this role. Please only apply if this location is accessible to you. .
The Associate Director, Neuroscience Priority Accounts, will play a pivotal role in shaping the success of our Neuroscience Multiple Sclerosis portfolio within key health systems and priority accounts. In this role, you'll lead strategic initiatives that drive meaningful impact - building strong partnerships, creating tailored account business plans, and ensuring seamless product access for patients who need them most. Working closely with cross-functional teams, you'll bring innovative solutions to sophisticated healthcare environments and help deliver on our mission to improve lives through neuroscience. You'll also leverage deep expertise in institutional selling and health system dynamics to uncover new opportunities and optimize outcomes for both patients and providers.
About the Role
Key Responsibilities:
* Champion institutional advocacy to support formulary adoption and ensure appropriate use of approved neuroscience products.
* Build strong, collaborative relationships with leaders across our most sophisticated priority accounts and affiliated health systems.
* Design and execute strategic key-account plans that deliver meaningful outcomes for identified accounts.
* Significant customer-facing time, creating and executing short term and long-term KOL engagement plans.
* Identifies evidence gaps across product and disease education through appropriate thought leader discussions
* Partner with administrative, clinical, operational, and financial stakeholders to streamline care pathways, treatment protocols, and workflow solutions.
* Apply deep understanding of market dynamics, access models, and reimbursement trends to inform strategic decisions.
* Collaborate with local partners to create tailored, institution-specific plans that reflect market forces and customer priorities.
* Lead cross-functional teams to align strategies, update business plans, and achieve product goals within priority accounts.
* Conduct regular needs assessments and provide actionable insights to internal partners, driving innovative solutions and new business opportunities.
Essential Requirements:
* Bachelor's degree required from 4-year college or university.
* 8+ years' experience in pharmaceutical, biotech, healthcare, or similarly structured industries with large, geographically dispersed sales teams. We also welcome candidates from other complex sales environments such as medical devices, diagnostics, life sciences services, insurance, consumer health, or B2B sectors, especially where strong field leadership and customer engagement are central to success.
* 2+ years' experience in project management and translation of strategy into execution.
* 3+ years' experience managing complex accounts, including large academic centers and hospitals, with demonstrated success in strategic account management.
* Recent US experience (within last 5 years) with deep understanding of US healthcare ecosystems.
* Demonstrated deep customer and cross-functional knowledge, healthcare ecosystem thinking, with strong business acumen and technology/digital engagement proficiency.
* Robust business background, with a strong ability to collaborate and work cross-functionally in a matrix environment to build effective strategic account plans aligned to customer and organization goals.
* Candidate must reside within territory, or within a reasonable daily commuting distance of 100 miles from the territory border. Ability to travel 60-80% over a broad geography is required, with the ability to drive and/or fly within the territory. Must have a valid driver's license.
Desirable Requirements:
* Prior experience engaging with assigned neuroscience accounts and building strong, collaborative relationships.
* Background in at least two cross-functional areas, such as, but not limited to Marketing, Medical, Market Access & Reimbursement, or Sales Leadership - demonstrating versatility and strategic insight.
Driving is an Essential Function of this Role: Meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving.
COVID-19 Vaccine Policy (customer-facing roles only): While Novartis does not require vaccination for COVID-19 or proof of a recent negative test result for COVID-19 at this time, employees working in customer-facing roles must adhere to and comply with customers' (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to **********************************.
For Field Roles with a Dedicated Training Period: The individual hired for this role will be required to successfully complete certain initial training, including home study, eight (8) or fewer hours per day and forty (40) or fewer hours per week.
Novartis Compensation Summary:
The salary for this position is expected to range between $160,300 and $297,700 per year.
The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.
Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?
#LI-Remote This is a field-based and remote opportunity supporting key accounts in an assigned geography. Novartis is unable to offer relocation support for this role. Please only apply if this location is accessible to you.
Company will not sponsor visas for this position.
The Associate Director, Neuroscience Priority Accounts, will play a pivotal role in shaping the success of our Neuroscience Multiple Sclerosis portfolio within key health systems and priority accounts. In this role, you'll lead strategic initiatives that drive meaningful impact - building strong partnerships, creating tailored account business plans, and ensuring seamless product access for patients who need them most. Working closely with cross-functional teams, you'll bring innovative solutions to sophisticated healthcare environments and help deliver on our mission to improve lives through neuroscience. You'll also leverage deep expertise in institutional selling and health system dynamics to uncover new opportunities and optimize outcomes for both patients and providers.
Job Description
Key Responsibilities:
Champion institutional advocacy to support formulary adoption and ensure appropriate use of approved neuroscience products.
Build strong, collaborative relationships with leaders across our most sophisticated priority accounts and affiliated health systems.
Design and execute strategic key-account plans that deliver meaningful outcomes for identified accounts.
Significant customer-facing time, creating and executing short term and long-term KOL engagement plans.
Identifies evidence gaps across product and disease education through appropriate thought leader discussions
Partner with administrative, clinical, operational, and financial stakeholders to streamline care pathways, treatment protocols, and workflow solutions.
Apply deep understanding of market dynamics, access models, and reimbursement trends to inform strategic decisions.
Collaborate with local partners to create tailored, institution-specific plans that reflect market forces and customer priorities.
Lead cross-functional teams to align strategies, update business plans, and achieve product goals within priority accounts.
Conduct regular needs assessments and provide actionable insights to internal partners, driving innovative solutions and new business opportunities.
Essential Requirements:
Bachelor's degree required from 4-year college or university.
8+ years' experience in pharmaceutical, biotech, healthcare, or similarly structured industries with large, geographically dispersed sales teams. We also welcome candidates from other complex sales environments such as medical devices, diagnostics, life sciences services, insurance, consumer health, or B2B sectors, especially where strong field leadership and customer engagement are central to success.
2+ years' experience in project management and translation of strategy into execution.
3+ years' experience managing complex accounts, including large academic centers and hospitals, with demonstrated success in strategic account management.
Recent US experience (within last 5 years) with deep understanding of US healthcare ecosystems.
Demonstrated deep customer and cross-functional knowledge, healthcare ecosystem thinking, with strong business acumen and technology/digital engagement proficiency.
Robust business background, with a strong ability to collaborate and work cross-functionally in a matrix environment to build effective strategic account plans aligned to customer and organization goals.
Candidate must reside within territory, or within a reasonable daily commuting distance of 100 miles from the territory border. Ability to travel 60-80% over a broad geography is required, with the ability to drive and/or fly within the territory. Must have a valid driver's license.
Desirable Requirements:
Prior experience engaging with assigned neuroscience accounts and building strong, collaborative relationships.
Background in at least two cross-functional areas, such as, but not limited to Marketing, Medical, Market Access & Reimbursement, or Sales Leadership - demonstrating versatility and strategic insight.
Driving is an Essential Function of this Role: Meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving.
COVID-19 Vaccine Policy (customer-facing roles only): While Novartis does not require vaccination for COVID-19 or proof of a recent negative test result for COVID-19 at this time, employees working in customer-facing roles must adhere to and comply with customers' (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to **********************************.
For Field Roles with a Dedicated Training Period: The individual hired for this role will be required to successfully complete certain initial training, including home study, eight (8) or fewer hours per day and forty (40) or fewer hours per week.
Novartis Compensation Summary:
The salary for this position is expected to range between $160,300 and $297,700 per year.
The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.
Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call *************** and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range
$168,000.00 - $312,000.00
Skills Desired
Accountability, Account Management, Commercial Excellence, Competitive Intelligence, Complexity Management, Compliance, Crm (Customer Relationship Management), Customer Engagement, Enterprise Sales, Ethics, Healthcare Sector, Integrated Marketing, Market Development, matrixed collaboration, Problem Solving Skills, Process Knowledge, Revenue Growth, Sales Strategy, Selling Skills, Strategic Leadership, Value Propositions
$168k-312k yearly Auto-Apply 54d ago
Radioligand Therapies (RLT) Associate Director, Priority Accounts - Chicago
Novartis 4.9
Chicago, IL jobs
#LI-Remote This is a field-based and remote opportunity supporting key accounts in an assigned geography. Novartis is unable to offer relocation support for this role. Please only apply if this location is accessible to you.
Company will not sponsor visas for this position.
As a Radioligand Therapies (RLT) Associate Director, Priority Accounts, you'll partner with Neuroendocrine Tumors (NET) Centers of Excellence and health care system sites to drive impactful engagement. This role focuses on creating and executing strategic business plans for key accounts while collaborating with cross-functional teams to deliver institution-centric programs aligned with business priorities and compliance standards. You'll lead commercial strategies, foster strong relationships with senior stakeholders, and provide operational and financial insights to uncover new opportunities. Success in this position calls for expertise in healthcare systems, access navigation, and collaborative problem-solving.
Job Description
Key Responsibilities:
Champion institutional advocacy for the adoption of the Radioligand Therapies (RLT) and Neuroendocrine Tumors (NET) brand to support appropriate product utilization.
Build strong partnerships with Neuroendocrine Tumors Centers of Excellence and health care system sites to drive impactful engagement.
Develop, coordinate, and execute strategic business plans for priority accounts, ensuring alignment with market dynamics and organizational goals.
Cultivate relationships with clinical, operational, and administrative decision-makers; and support their efforts to streamline care pathways, treatment protocols and workflow solutions to enable patient access.
Stay informed on market trends, customer economics, and access models, including payment programs and reimbursement strategies.
Compliantly share knowledge of Novartis' offerings and ensure account administrators have access to relevant resources, while maintaining compliance.
Collaborate with local teams to create tailored, institution-specific plans that reflect local market forces and opportunities.
Educate clinicians, staff and other institutional stakeholders on disease state and/or product information as appropriate to support institutional adoption of Radioligand Therapies (RLT) and development of relevant treatment pathways and protocols.
Develop a clear understanding of customer needs across the ecosystem - from departments to executive leadership. Use insights to anticipate trends, shape priorities, and deliver impactful outcomes.
Support team members in diagnosing business challenges and implementing strategies that optimize outcomes for Radioligand Therapies and Neuroendocrine Tumors accounts and affiliated health systems.
Essential Requirements:
Bachelor's degree required from 4-year college or university.
8+ years' experience in pharmaceutical, biotech, healthcare, or similarly structured industries with large, geographically dispersed field teams. We also welcome candidates from other complex environments such as medical devices, diagnostics, life sciences services, insurance, consumer health, or B2B sectors, especially where strong field leadership and customer engagement are central to success
.
2+ years' experience in project management and translation of strategy into execution.
3+ years' experience managing complex accounts, including large academic centers and hospitals, with demonstrated success in strategic account management.
Recent US experience (within last 5 years) with deep understanding of US healthcare ecosystems.
Demonstrated deep customer and cross-functional knowledge, healthcare ecosystem thinking, with strong business acumen and technology/digital engagement proficiency.
Robust business background, with strong ability to collaborate and work cross-functionally in a matrix environment to build effective strategic account plans aligned to customer and organization goals.
Candidate must reside within territory or reside in a territory adjacent to the assigned geography. Ability to travel 60-80% over a broad geography is required, with the ability to drive and/or fly within the territory. Must have a valid driver's license.
Desirable Requirements:
Strong knowledge of the Radioligand Therapies (RLT) platform and experience representing Radioligand Therapies products, with a proven ability to drive adoption at scale.
Cross-functional experience in areas such as Marketing, Medical, Market Access, Reimbursement, or Sales Leadership, and prior engagement with assigned accounts.
Driving is an Essential Function of this Role: Meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving.
COVID-19 Vaccine Policy (customer-facing roles only): While Novartis does not require vaccination for COVID-19 or proof of a recent negative test result for COVID-19 at this time, employees working in customer-facing roles must adhere to and comply with customers' (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to **********************************.
For Field Roles with a Dedicated Training Period: The individual hired for this role will be required to successfully complete certain initial training, including home study in eight (8) or fewer hours per day and forty (40) or fewer hours per week.
Novartis Compensation Summary:
The salary for this position is expected to range between: $168,000 and $312,000 per year.
The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.
Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call *************** and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range
$168,000.00 - $312,000.00
Skills Desired
Accountability, Account Management, Commercial Excellence, Competitive Intelligence, Complexity Management, Compliance, Crm (Customer Relationship Management), Customer Engagement, Enterprise Sales, Ethics, Healthcare Sector, Integrated Marketing, Market Development, matrixed collaboration, Problem Solving Skills, Process Knowledge, Revenue Growth, Sales Strategy, Selling Skills, Strategic Leadership, Value Propositions
$168k-312k yearly Auto-Apply 60d ago
Regional Director of MSLs, Onc RLT South East Region Remote
Novartis 4.9
Remote
This position focuses on disease states (e.g. prostate cancer, neuroendocrine tumors, & etc.) being treated by Novartis' Radioligand Therapies. Bringing life-changing medicines to millions of people, Novartis sits at the intersection of cutting-edge medical science and innovative digital technology.
As a global company, the resources and opportunities for growth and development are plentiful including global and local cross functional careers, a diverse learning suite of thousands of programs & an in-house marketplace for rotations & project work. With strong medicines pipeline our current transformation will not just deliver growth for our business but continue to allow us to bring innovative medicines to patients quickly.
The Regional Director of Medical Science Liaisons (RDM) is a field based, non-promotional medical and scientific leadership role. Their key accountability is the development and execution of an impact-driven medical strategy for their assigned Field Team, aligned with the overarching Medical Strategy, with the goal of improving patient care.
The RDM provides strategic direction and leadership to their assigned Field Medical Team while functioning within the Novartis Code of Conduct, Ethics, Risk and Compliance policies and Working Practice documents. The position requires proactive decision-making, leading initiatives within the team, cross-functional collaboration, and alignment with key stakeholders.
The RDM drives execution of the medical strategies by setting the direction and providing clear communication of objectives and expectations to Medical Science Liaisons (MSLs) direct reports and strategic guidance regarding key accounts. They are also accountable for performance of the MSLs within their team, optimal resource management, and the cultivation and recruitment of high performing talent through ongoing coaching and development. The RDM is responsible for establishing a high performing team culture aligned to Novartis values and behaviors.
The RDM drives cross-functional collaboration through participation in forums to share best practices and build innovation. They lead cross-functional collaboration with senior internal stakeholders to improve or implement novel approaches to partnerships with external customers (Medical Experts, HCPs, Accounts, etc.) to drive medical and/or clinical goals.
The RDM may serve as a peer leader driving internal initiatives and process improvements for the field teams. They ensure field training and readiness, scientific expertise, understanding and adoption of technology, and compliant business practices of their respective field teams. RDM should have a deep understanding of the regional environment and key customers, accounts, and medical experts.
This position can be based remotely in US, preferred location Atlanta Metropolian Area. Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. Ability to travel 60-70% over a broad geography is required, with the ability to drive and/or fly within the territory.
Job Description
What you will bring to the role:
• Minimum graduate degree in science or a healthcare degree required; doctoral degree (MD, PharmD, DNP, PhD, etc.) strongly preferred.
• Minimum 7 years in pharmaceutical industry with roles of increasing complexity and responsibility required.
• Minimum of 7 years' experience in a Field-based position within the pharmaceutical industry or as a MSL is strongly preferred.
• Knowledge of clinical medicine, disease management, and medical research practices strongly preferred.
• Previous management experience of field-based associates preferred.
• Must possess a thorough understanding of the FDA, OIG, HIPAA, PhRMA Code and other ethical guidelines relevant to the pharmaceutical industry, to ensure compliance with these external as well as internal guidelines and standard operating procedures.
• Must be able to organize, prioritize and work effectively in a constantly changing environment.
• Working knowledge of Microsoft Office Suite (Word, PowerPoint, Excel), Apple device operation, digital tools / platforms, virtual customer platforms engagement platforms and associated hardware is required.
• Must be strong team player who can effectively collaborate cross-functionally in a highly matrixed organization.
• Must have strategic mindset, strong business acumen and ability to navigate complex healthcare landscape able to identify, network and partner with medical experts, including thought leaders, large group practices, medical directors, and pharmacy directors is required.
• The ability to give and receive feedback and the ability to coach to optimal performance to their direct reports is required.
• Must be driven more by the success of others / team than personal success.
• Excellent interpersonal, verbal and written communication, and presentation skills are required.
• Conduct yourself with the highest ethical standards and adhere to Novartis Code of Conduct. Comply with all relevant laws and regulations and Novartis Ethics, Risk & Compliance policies, and procedures.
• Must conduct themselves with highest ethical standards and adhere to Novartis Code of Conduct. Comply with all relevant state and federal laws and regulations and Novartis Ethics, Risk & Compliance and other company policies, and procedures, and ensure others around him/her do the same.
• Works to ensure a diverse and inclusive environment free from all forms of discrimination and harassment
• This is a field based, customer-facing position that is associated with approximately 60-70% travel, ability to travel required.
NOTE: Above level experience criteria are not an exhaustive list
Field roles with a dedicated training period only:
The individual hired for this role will be required to successfully complete certain initial training, including home study, in eight (8) or fewer hours per day and forty (40) or fewer hours per week.
Field roles with a company car: Driving is an essential function of this role, meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions, if an accommodation can be provided without eliminating the essential function of driving.
The pay range for this position at commencement of employment is expected to be between $261,100 - $484,900 a year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions.
To learn more about the culture, rewards and benefits we offer our people click here.
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call *************** and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range
$261,100.00 - $484,900.00
Skills Desired
Clinical Research, Clinical Study Reports, Customer Engagement, Customer Insights, Disease Management, Health Economics, Internal Medicine, Medical Communication, Medical Information, Microsoft PowerPoint, Microsoft Word, Patient Care, Phase Iv Clinical Trial, Product Placement, Scientific Support, Strategic Direction, Team Player, Teamwork, Utilization Management (Um)
$143k-199k yearly est. Auto-Apply 3d ago
Regional Director of MSLs, Onc RLT South East Region Remote
Novartis AG 4.9
Remote
This position focuses on disease states (e.g. prostate cancer, neuroendocrine tumors, & etc.) being treated by Novartis' Radioligand Therapies. Bringing life-changing medicines to millions of people, Novartis sits at the intersection of cutting-edge medical science and innovative digital technology.
As a global company, the resources and opportunities for growth and development are plentiful including global and local cross functional careers, a diverse learning suite of thousands of programs & an in-house marketplace for rotations & project work. With strong medicines pipeline our current transformation will not just deliver growth for our business but continue to allow us to bring innovative medicines to patients quickly.
The Regional Director of Medical Science Liaisons (RDM) is a field based, non-promotional medical and scientific leadership role. Their key accountability is the development and execution of an impact-driven medical strategy for their assigned Field Team, aligned with the overarching Medical Strategy, with the goal of improving patient care.
The RDM provides strategic direction and leadership to their assigned Field Medical Team while functioning within the Novartis Code of Conduct, Ethics, Risk and Compliance policies and Working Practice documents. The position requires proactive decision-making, leading initiatives within the team, cross-functional collaboration, and alignment with key stakeholders.
The RDM drives execution of the medical strategies by setting the direction and providing clear communication of objectives and expectations to Medical Science Liaisons (MSLs) direct reports and strategic guidance regarding key accounts. They are also accountable for performance of the MSLs within their team, optimal resource management, and the cultivation and recruitment of high performing talent through ongoing coaching and development. The RDM is responsible for establishing a high performing team culture aligned to Novartis values and behaviors.
The RDM drives cross-functional collaboration through participation in forums to share best practices and build innovation. They lead cross-functional collaboration with senior internal stakeholders to improve or implement novel approaches to partnerships with external customers (Medical Experts, HCPs, Accounts, etc.) to drive medical and/or clinical goals.
The RDM may serve as a peer leader driving internal initiatives and process improvements for the field teams. They ensure field training and readiness, scientific expertise, understanding and adoption of technology, and compliant business practices of their respective field teams. RDM should have a deep understanding of the regional environment and key customers, accounts, and medical experts.
This position can be based remotely in US, preferred location Atlanta Metropolian Area. Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. Ability to travel 60-70% over a broad geography is required, with the ability to drive and/or fly within the territory.
About the Role
What you will bring to the role:
* Minimum graduate degree in science or a healthcare degree required; doctoral degree (MD, PharmD, DNP, PhD, etc.) strongly preferred.
* Minimum 7 years in pharmaceutical industry with roles of increasing complexity and responsibility required.
* Minimum of 7 years' experience in a Field-based position within the pharmaceutical industry or as a MSL is strongly preferred.
* Knowledge of clinical medicine, disease management, and medical research practices strongly preferred.
* Previous management experience of field-based associates preferred.
* Must possess a thorough understanding of the FDA, OIG, HIPAA, PhRMA Code and other ethical guidelines relevant to the pharmaceutical industry, to ensure compliance with these external as well as internal guidelines and standard operating procedures.
* Must be able to organize, prioritize and work effectively in a constantly changing environment.
* Working knowledge of Microsoft Office Suite (Word, PowerPoint, Excel), Apple device operation, digital tools / platforms, virtual customer platforms engagement platforms and associated hardware is required.
* Must be strong team player who can effectively collaborate cross-functionally in a highly matrixed organization.
* Must have strategic mindset, strong business acumen and ability to navigate complex healthcare landscape able to identify, network and partner with medical experts, including thought leaders, large group practices, medical directors, and pharmacy directors is required.
* The ability to give and receive feedback and the ability to coach to optimal performance to their direct reports is required.
* Must be driven more by the success of others / team than personal success.
* Excellent interpersonal, verbal and written communication, and presentation skills are required.
* Conduct yourself with the highest ethical standards and adhere to Novartis Code of Conduct. Comply with all relevant laws and regulations and Novartis Ethics, Risk & Compliance policies, and procedures.
* Must conduct themselves with highest ethical standards and adhere to Novartis Code of Conduct. Comply with all relevant state and federal laws and regulations and Novartis Ethics, Risk & Compliance and other company policies, and procedures, and ensure others around him/her do the same.
* Works to ensure a diverse and inclusive environment free from all forms of discrimination and harassment
* This is a field based, customer-facing position that is associated with approximately 60-70% travel, ability to travel required.
NOTE: Above level experience criteria are not an exhaustive list
Field roles with a dedicated training period only:
The individual hired for this role will be required to successfully complete certain initial training, including home study, in eight (8) or fewer hours per day and forty (40) or fewer hours per week.
Field roles with a company car: Driving is an essential function of this role, meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions, if an accommodation can be provided without eliminating the essential function of driving.
The pay range for this position at commencement of employment is expected to be between $261,100 - $484,900 a year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions.
To learn more about the culture, rewards and benefits we offer our people click here.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?
$143k-199k yearly est. 2d ago
Executive Director, Global Value Evidence Lead
Otsuka America Pharmaceutical Inc. 4.9
Springfield, IL jobs
The ExecutiveDirector, Global Value Evidence Lead, is a strategic leader responsible for driving the global value evidence strategy across the company's portfolio. This senior leader will provide strategic vision and leadership for value evidence activities at Otsuka, ensuring robust, innovative, and fit-for-purpose evidence is generated to support product differentiation, market access, and reimbursement across geographies. The incumbent will lead a team of value evidence asset leads and collaborate with internal and external stakeholders to shape the value narrative and evidence plans from early development through post-launch.
**Key Responsibilities:**
+ Oversee the Global Value Evidence (GVE) strategic planning and execution processes to ensure alignment with asset and company business priorities
+ Lead team of value evidence TA and assets leads who design and implement HEOR, RWE, and other evidence generation initiatives to support regulatory, HTA, and payer submissions, and demonstrate the differentiated value of our products
+ Utilize advanced scientific knowledge and emerging trends to drive innovation in value evidence
+ Provide mentorship, support in career development and performance management for direct reports
+ Enhance the department's capabilities by developing skills, nurturing a culture of scientific excellence, and ensuring strategic impact
+ Support in proactively identifying and solving complex problems that impact the management and direction of the GVE department
+ Cultivate strong, collaborative relationships with key internal stakeholders and communicate matters of significant importance to the department, broader function and organization
+ Represent the company in external engagements with HTA bodies, payers, academic institutions, and industry consortia.
+ Ensure compliance with global regulatory and ethical standards in evidence generation and data use.
**Qualifications:**
+ Advanced degree (PhD, PharmD, MD, MPH, or equivalent) in a relevant scientific or health-related field.
+ 10+ years of experience in pharmaceutical, biotech, or healthcare consulting, with a strong focus on HEOR, RWE, and market access strategy.
+ Demonstrated leadership in developing and executing global evidence strategies for successful product launches and access.
+ Recognized within the outside scientific community as a thought leader in value evidence through publication in peer reviewed journals, presentations, involvement in scientific/professional associations etc.
+ Deep understanding of global HTA and payer requirements, regulatory frameworks, and healthcare systems.
+ Deep understanding of industry best practices
+ Exceptional strategic thinking, communication, and stakeholder engagement skills.
+ Proven ability to lead cross-functional teams and influence senior leadership.
**Preferred Qualifications:**
+ Experience in multiple therapeutic areas, including specialty or rare diseases.
+ Familiarity with innovative evidence platforms, digital health technologies, and advanced analytics.
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $245,454.00 - Maximum $381,110.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
$245.5k yearly 60d+ ago
Executive Director, Global Clinical Development Program Lead- CNS/Psychiatry
Otsuka America Pharmaceutical Inc. 4.9
Springfield, IL jobs
Within Otsuka Pharmaceutical Co. exists Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) a U.S.A. subsidiary exists the Global Clinical Development (GCD) department. OPDC-GCD are a group of physicians and scientists who lead clinical development activities for Otsuka's global health-care products.
The Global Clinical Development Program Leader is responsible for leading the end-to-end strategy, and development and delivery of a portfolio of novel serotonergic agonists (NSA). Shaping and executing late-stage clinical development strategies for the NSA portfolio of therapeutic assets, ensuring programs progress efficiently toward registration and commercialization. This role serves as the primary and single point of contact for internal and external stakeholders, ensuring seamless integration, governance, and lifecycle management from early-stage development through submission to global health authorities. This role provides scientific, clinical, and strategic leadership across Phase II/III program design, evidence-generation plans, regulatory interactions, and cross-functional integration to support differentiated therapeutic value and patient outcomes. In addition to overseeing clinical development, the leader will play a central role in creating a unique, patient-centered go-to-market strategy tailored to the emerging psychedelic medicines landscape. This includes orchestrating health economics and outcomes research, defining care-delivery models, navigating reimbursement and market access pathways, and partnering with commercial, medical affairs, and external stakeholders to build scalable, ethically grounded treatment ecosystems.
****
The specific duties assigned to the ExecutiveDirector; Global Clinical Development Program Lead will include the following:
**Key Role Accountabilities:**
Summary of Global Clinical Development Program Lead for the NSA Portfolio include:
+ Establish & continually evolve global portfolio strategy indications/sequencing. Align with Product Development Committee (PDC) and the Early Development Team (EDT) based on internal strategy and competitive landscape
+ Recommend individual asset strategies that supports a differentiated product profile including proposed go/no-go criteria (early to late phase)
+ Broader portfolio evidence generation strategy
+ Align COA endpoint development and validation work across individual assets
+ Drive portfolio-wide stakeholder strategy through external landscape & policy shaping (GA, PASM, GMA, GRA, Corporate Comms) and identify synergies with the broader CNS portfolio
+ Drive internal and external communication strategy
+ Develop and continually evolve differentiated global go-to-market strategy based on unique attributes of assets within the portfolio:
+ Reimbursement and coding coverage
+ Broader portfolio global commercialization assessment/planning to drive asset's global CDP
+ Patient support/wrap around services
+ Provide overall portfolio asset prioritization and support for discovery programs and indication selection
+ Set overarching regulatory strategy and endorse individual asset strategies as needed
+ Endorse proposed go/no-go criteria and support PDC for action points and EDTs for governance engagement for portfolio assets
+ Endorse CDPs for discovery/early stage and late-stage programs
+ Portfolio KOL engagement & patient advocacy strategy
**Strategy & Execution**
+ Serve as the primary point of contact for key partners, ensuring collaborative and productive relationships.
+ Drives the asset's initial indication development strategy, including scientific, regulatory, and clinical access.
+ Drives asset/brand vision and strategy through all lifecycle development activities, including registrational studies, as well as post-marketing studies
+ Shapes products for competitive profile that achieves pricing, reimbursement, access and penetration by developing target product profile, developing initial indication label in-line with target profile, and creating economic value dossier
+ Oversees and adheres to the governance processes for the selected asset and drives the achievement of key milestones
+ Develops focused expertise to serve as an internal medical/scientific consultant to health economic, medical affairs, marketing, regulatory, statistical and other team members, and to external regulatory agencies.
+ Constantly seeks innovative ways to grow the value of the asset throughout the product lifecycle by leveraging the team's experience and skillset.
+ Co-leads regulatory filing activities through NDA. Provides strategic direction to ensure concise, clear and convincing argumentation in all written and verbal communications.
+ Recommends Business Development activities necessary for optimization of the portfolio value i.e., provide development perspective during due diligence or recommend opportunities that can help further support the specific portfolio group of assets
**Leadership & Matrix Management**
+ Sets vision for the Product Development Team and ensures the matrix team remains aligned and engaged toward that vision
+ Oversees relevant sub-teams and ensures clear goals are aligned with development team short- and long-term and performance standards are in place. Provides feedback and coaching and holds sub-team leaders accountable for key deliverables
+ Manages performance across the matrix team, in collaboration with the functional leaders.
+ Demonstrates peer-to-peer influence across R&D functional leadership
+ Establishes trusting relationships locally and globally across the enterprise to advocate for the asset
**Stakeholder Engagement & Communication**
+ Manages integration points and communications with key stakeholders across all Otsuka functions and market areas to ensure alignment and minimize risk
+ Monitor and manage contractual obligations, performance metrics, and governance structures.
+ Ensures appropriate decisions are made in a timely manner and effectively navigates relevant governance to keep stakeholders informed and aligned while driving outcomes
+ Builds and manages relationships with external stakeholders (Opinion Leaders, Patient advocacy leaders, health authorities)
+ Support interpretation of key clinical trial results, regulatory feedback and other relevant information and lead the integration of these new findings into the cross-functional asset strategy
**Qualifications**
Required
+ A minimum of 10 years of experience in the pharmaceutical industry, extensive working knowledge in the drug development process with proven progression in relevant R&D roles and significant experience in related therapeutic areas as well as pediatric drug development.
+ Experience in managing/leading high performance, cross-functional teams (Matrix) or complex organizations successfully
+ Understanding of regulatory policies and impact of public relations (US and Global preferred)
+ Demonstrated ability to successfully and effectively collaborate, cooperate and work across boundaries (e.g. R&D, disease mgt., marketing, external development) and building strong external relationships
+ Abreast of scientific issues as they impact business development and strategic planning
+ Success in situations requiring rigorous, analytical problem solving and the ability to determine scientific opportunity and commercial targets
+ Understanding of regulatory policies and impact of public relations
+ Demonstrated use of communication and change management strategies/tactics to influence new ways of thinking and working
+ Success in effectively communicating and influencing decisions with senior management
+ Ability to navigate through ambiguous and changing healthcare landscape
+ An ability to communicate effectively in meetings and via written and oral presentations is essential. This includes facility with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
+ Working knowledge of associated disciplines, including biostatistics, clinical pharmacology, formulation science, data management, and medical writing.
+ Understanding of the global regulatory requirements. Demonstrated experience in successful regulatory filings
+ Working knowledge of the principles of health value creation, including financial assessment (e.g., net present value), project planning and budgeting, market research and commercialization strategies.
+ Willingness to travel 35% of time, over weekends and ability to travel internationally..
Preferred
+ MD / PhD / PharmD / secondary scientific degree preferred or commensurate experience
+ Medical, clinical and/or public health experience within the therapeutic area of psychiatry or neurology
**Disclaimer**
This is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $249,973.00 - Maximum $388,125.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
$75k-130k yearly est. 22d ago
Executive Director, Medical Affairs Strategy Excellence & Operations
Otsuka America Pharmaceutical Inc. 4.9
Springfield, IL jobs
As a senior leader within Medical Affairs, the ExecutiveDirector will serve as a strategic thought partner and Chief of Staff to the Vice President of Medical Affairs, providing high-level guidance and operational leadership across the organization. Leveraging a deep understanding of industry trends and internal priorities, this individual will shape the development of best-in-class medical excellence capabilities aligned with Otsuka's vision, direction, and growth strategy.
The ExecutiveDirector, Medical Affairs Strategy, Excellence & Operations will lead five critical teams: Strategic Planning, Business Solutions & Analytics, Vendor & Contracts Management, Governance & Procedures, and Global Medical Evidence Operations ensuring alignment with enterprise goals and medical excellence priorities. This role will champion operational rigor, foster strategic integration, and drive high-quality insights to support decision-making across the organization.
Serving as a key liaison across the Global, US, and Commercial ecosystem, the ExecutiveDirector will play a pivotal role in advancing scientific and medical initiatives. Through thoughtful leadership and collaboration, this individual will shape and execute the global medical affairs strategy, optimize operational frameworks, and enable data-driven innovation across therapeutic areas.
****
**Key Responsibilities Include:**
**Strategic Leadership and Execution**
+ Serve as Chief of Staff to the VP of Medical Affairs, driving strategic alignment and operational integration across the Global Medical Affairs organization.
+ Sets the overall direction of Medical Excellence & Operations (MEO); make critical decisions that have impact across Global Medical Affairs therapeutic areas (TAs) and functions
+ Leads the development, refinement, and execution of Medical Affairs strategies and objectives in alignment with corporate goals.
+ Coordinates cross-functional planning, meeting cadences, budget oversight, and communication on behalf of Medical Affairs leadership.
+ Collaborates with cross-functional teams to align medical affairs activities with commercial and clinical development strategies
+ Leads Medical Excellence for Med Affairs Strategy to ensure consistent best practices across programs and drive consistent methods of strategic and tactical planning and execution.
**Operational Excellence and Team Management**
+ Lead and manage core operational pillars within Medical Affairs Excellence & Operations Team, including:
+ Global Asset Strategic Planning
+ Business Solutions and Analytics
+ Vendor and Contracts management
+ Global Medical Evidence Operations
+ Governance and Procedures
+ Establish and implement systems, SOPs, and governance frameworks to ensure excellence, compliance, and efficiency in Medical Affairs processes (e.g., IME, ISTs, EAPs, publications, congresses)
+ Provide and maintain the technological infrastructure, business tools, and data analytics, including the medical information contact center, to enable Global Medical Affairs teams to operate efficiently
+ Oversee the department's budget, resource allocation, and vendor contracting processes (including key TA level vendors)
+ Will ensure assignment of Med Excellence activities/projects to Otsuka priorities
+ Congress Strategy/prioritization, ensure aggregation of congress plans (including meetings) and awareness cross functionally
+ Develop and maintain calendar of important TA meetings across programs, including congresses and internal offsite meetings (US and Global) to ensure no conflicts and adequate resourcing; will work with Administrative leads to ensure meetings are added to calendars
+ Develops and manages large teams driving a high-performance culture; understands the required skillset (s) needed within the medical excellence function to deliver best results
+ Builds relationships with key internal and external stakeholders, including industry partners
**Performance Monitoring and Reporting**
+ Establish and track key performance indicators (KPIs) to measure Medical Affairs impact and execution
+ Deliver monthly and quarterly updates to Global Medical Affairs leadership and contribute to board-level reporting, as needed
+ Keeps abreast external environment-relevant trends and incorporates insights and best practices to inform functional decisions
+ Responsible for ensuring timelines and process for cross-brand initiatives, such as annual medical strategy planning, 3-year roadmaps, SMART goals
**Qualifications**
**Education and Experience:**
+ Doctorate Degree (MD (Medical Doctor), PharmD, PhD) or equivalent preferred
+ Minimum of 15 years' experience in the pharmaceutical or biotechnology setting within medical affairs strategy
+ Sr Director level medical affairs strategy experience for a minimum of 5 yrs. and experience in Medical Excellence & operations
**Skills and Competencies:**
+ Demonstrated ability to lead and inspire high-performing teams
+ Strong strategic, operational, and leadership capabilities within a biotech or pharmaceutical setting
+ Expertise in navigating regulatory frameworks and ensuring compliance within medical affairs function
+ Excellent communication and interpersonal skills, with the ability to influence cross-functional teams
+ Strong analytical and problem-solving skills to address complex challenges within medical affairs
+ Ability to lead a team and influence organizational level decisions
+ Experience in collaborating with Medical Affairs vendors that can provide medical excellence related support
+ Strategic thinking acumen and record of accomplishment for operational excellence
+ Ability to rapidly pivot based on evolving corporate strategy and direction
+ Proficiency in pharma code and all guidelines concerning medical affairs activities
+ Excellent presentation skills and ability to communicate complex scientific information
+ Motivated, disciplined, pro-active individual capable of effectively managing timelines
**Other Requirements:**
+ Ability to travel globally up to 25% for congresses, advisory board meetings, Governance meetings as business needs require
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $245,454.00 - Maximum $381,110.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
$245.5k yearly 60d+ ago
Associate Director, Regulatory Intelligence
Otsuka America Pharmaceutical Inc. 4.9
Springfield, IL jobs
The Associate Director of Regulatory Intelligence leads the collection and dissemination of regulatory intelligence and collaborates with SMEs to interpret the impact of regulatory changes to the pharmaceutical environment. **** + Oversee the capture, review, and dissemination of global regulatory news, public commenting opportunities, new and updated regulations and guidance that may impact pharmaceutical practices, procedures and controlled documents.
+ Lead weekly regulatory intelligence team meetings to include review and discussion of ad hoc query requests, regulatory background package requests, health authority guidance, Federal Register notices, public commenting opportunities, and newsletter content.
+ Manage development and distribution of weekly regulatory intelligence newsletters and regulatory watch notifications.
+ Ensure regulatory intelligence specialists have continued access to regulatory, clinical trial, and public domain information resources to identify relevant regulatory-related news and information, and competitor product regulatory developments and report the most critical findings.
+ Discuss and triage any technical issues with the reg intel platform, access requests, and distribution issues.
+ Demonstrate comprehensive understanding of AI-enabled regulatory intelligence platform and dashboards to identify, tag, and summarize regulatory intelligence information.
+ Monitor organizational strategic priorities and participate in cross-departmental discussions to consistently capture relevant and targeted regulatory intelligence.
+ Regularly review and update AI taxonomy terms relevant to Otsuka approved and investigational products, clinical, and business development programs.
+ Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory intelligence needs and strengthen and support Otsuka as a learning organization.
+ Maintain close communication with Informational Technology, Regulatory Technology, and the software vendor to maintain optimal functioning of the regulatory intelligence technology platform.
+ Lead internal process to obtain, coordinate, and document cross-functional SME impact assessments of new or updated guidance and regulations.
+ Lead regulatory public commenting process and posting of Otsuka comments to health authority websites.
+ Review and update Regulatory Intelligence homepage on GRA Collaboration Portal.
+ Manage onboarding and offboarding of regulatory intelligence team members, provide input on team member performance, establish annual budget, and manage spend.
+ Author and conduct periodic review of regulatory intelligence management Standard Operating Procedures or work practices.
+ Review overall quality of ad hoc query research for requested regulatory topics and confirm acceptability of responses.
+ Demonstrate understanding of the major regional and global industry association priorities (e.g., PhRMA, EFPIA, JPMA, etc.).
+ Demonstrate solid working knowledge of the drug, biologic, and device development process, laws, regulations, and guidelines from FDA, EMA, PMDA, ICH, etc.
+ General knowledge of global regulations for pharmacovigilance reporting for approved and investigational products.
+ Confirm list of upcoming regulatory meetings/workshops/conferences remains current.
**Qualifications**
+ Master's degree in a scientific or technical discipline preferred.
+ Minimum of 5 years of regulatory affairs experience.
+ Minimum 2-3 years' work experience in regulatory intelligence.
+ Previous interactions with FDA or other health authority are desirable.
**Skills and Competencies:**
+ Demonstrates the ability to plan, direct, organize, and coordinate projects.
+ Demonstrates experience interacting with and supporting senior leadership.
+ Previous experience with people management and team leadership.
+ Excellent interpersonal and communication skills, both written and verbal.
+ Previous experience developing newsletters is desirable.
+ Results driven and team-oriented collaborative approach required.
+ Critical thinking and problem-solving skills.
+ Strong demonstrated experience with Microsoft Office programs (Word, Excel, PowerPoint, Outlook).
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $164,530.00 - Maximum $245,985.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
$164.5k yearly 60d+ ago
Associate Director, Global Labeling
Otsuka America Pharmaceutical Inc. 4.9
Springfield, IL jobs
Responsible for working with cross-functional teams across the organization to drive and align the development and maintenance of global labeling (e.g. CCDS, regional product labels, and patient labeling) for assigned compounds. Makes recommendations and provides labeling advice and feedback for labeling content, processes, and timelines to ensure compliance with labeling regulations and guidance. Delivers high-quality submission labeling and artwork for complex drug products, specific therapeutic/disease areas, and cross functional teams. Actively contributes to continuous improvement of end-to-end labeling processes and systems.
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+ Act as Global Labeling Strategy Lead, supporting preparation, review, and update of content for the development and maintenance of Company Core Data Sheet (CCDS), local labeling and labeling components.
+ Lead the cross-functional labeling team for assigned compounds to drive alignment of labeling content and strategy.
+ Partner with Global Regulatory Affairs to ensure that all labeling is aligned with the product global strategy and key messaging.
+ Evaluate and communicate risks associated with CCDS content updates and implementation strategies.
+ Drive labeling for package labeling (artwork) development, update, and maintenance through collaboration with a cross-functional team.
+ Support global HA interaction strategy regarding all aspects of labeling, including submissions, responses to questions, and negotiations.
+ Demonstrate understanding of current labeling content requirements, regulations, and guidance to ensure all assigned compound labeling documents are accurate, consistent, and compliant.
+ Assess competitor labeling in the same therapeutic class, competitor labeling and labeling trends, proposing content as relevant to support optimized labeling
+ Support creation, compliance, update, and submission of SPL, including drug listing and establishment registration activities. Ensure that FDA postings are current and accurate (DailyMed, NDC Directory, Establishment Directory, etc).
+ Manage and maintain labeling documents in document management systems; Manage label review and approval.
+ Author, contribute, and/or review labeling sections of various periodic reports (i.e., Annual Report, PSUR, PADER, etc.).
+ Support inspection readiness activities related to all global labeling components.
+ Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate.
+ Collaborate with global Otsuka colleagues, Otsuka affiliates and Alliance partners, as needed.
+ Develop clear communications for senior management and labeling stakeholders, to streamline and facilitate label development, negotiations, and approval.
+ Review and propose continuous improvements to Global Labeling policies, end-to-end processes, quality, and system tools.
+ May be assigned additional responsibilities, as deemed necessary.
**Qualifications**
Required
+ MS/BS in life sciences or other scientific field.
+ 6-8 years of relevant experience in pharmaceutical regulatory/labeling environment and/or drug development
+ Knowledge of scientific principals and regulatory systems, relevant to drug development
+ Experience writing CCDS and local labeling documents for new products.
Preferred
**Knowledge and skills**
+ Solid understanding and practical knowledge of labeling regulatory requirements, regulations and guidance required
+ Solid understanding of implications of global labeling across the organization and globally
+ Solid understanding of the structure of product labeling
+ Experience in effectively/appropriately prioritizing and managing multiple high to medium complex projects simultaneously
+ Ability to work independently or in teams, globally. Ability to lead broad range of stakeholders at all levels internally and externally to the company.
+ Effective written and oral communication and organizational skills
+ Strong attention to detail
+ Solid aptitude for use of IT systems; preferable knowledge with Regulatory Information Management System (RIMS) and electronic document management system (EDMS); Proficiency in MS Office suite; Willing to learn additional applications
+ Ability to think strategically, communicate risks, and recommend problem solving innovative solutions
+ Ability to recognize and escalate issues
+ The ideal candidate should be action oriented, customer focused, ability to manage workloads and set priorities. In addition, he/she should be capable of dealing with ambiguity, be creative, be comfortable working with multifunctional teams.
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $164,530.00 - Maximum $245,985.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
$164.5k yearly 45d ago
Associate Director, Federal Government Affairs
Otsuka America Pharmaceutical Inc. 4.9
Springfield, IL jobs
The Associate Director (AD), Federal Government Affairs, will assist in the development, communication, and deployment of Otsuka's federal strategies, engagement activities and policy priorities that promote access to therapies, preserve patient/provider choice, and generally protect Otsuka's business interests in policy areas impacting Mental Health, Nephrology, Immunology, and Rare Disease. This role reports directly to the Director, Federal Government Affairs and located in the Washington, DC area.
The Associate Director will leverage Otsuka's resources including Otsuka US Political Action Committee (OUSPAC), trade associations and consultants to advance company policy positions. The AD will also work strategically to help advance, defeat or mitigate decisions or actions by the U.S. Congress and Administration that could negatively or positively affect our business or patients. Accountable for building and maintaining relationships with key members and staff of U.S. Congress as well as political appointees within an Administration, including communicating, advocating and direct lobbying of Otsuka policy positions.
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**Key responsibilities**
+ Monitor and analyze proposed and emerging federal legislation/regulation to determine its impacts on Otsuka business and the industry; help determine the most effective strategies to advance business priorities in coordination with the Government Affairs & Public Policy Leadership Team
+ Work in collaboration with the Director, Federal Government Affairs, to develop and implement federal strategies to achieve favorable results
+ Responsible for the successful execution of Otsuka's federal legislative goals, corporate initiatives, and internal business goals, and ensure focus to achieve these priorities
+ Interact with federal policy decision-makers and influencers, advocacy leaders, relevant committee chairs, members, support staff and others relevant officials regarding issues impacting access to care within the health care delivery system, in accordance with Otsuka strategic objectives
+ Help raise profile of Otsuka within various communities, including advocacy, political, and trade associations; seek out and serve in volunteer leadership roles to advance professional development and business objectives
+ Conduct all activities in compliance with all applicable federal laws and regulations and company policies
**Expectations**
+ Share relevant information freely, seek collaboration and input where appropriate; Achieve results with and through others across Gov't Affairs & Public Policy and the greater Corporate Affairs
+ Individual capable of identifying relevant public policy issues and implementing comprehensive plans to both protect and advance the interests of the Company
+ Effective communicator with strong presentation skills with the ability to interact with both external and internal audiences.
+ Demonstrate effective working relationships both within and outside of the team.
**Qualifications/ Required**
Knowledge/ Experience and Skills:
**Qualifications**
+ 5+ years of relevant legislative experience, primarily in healthcare, including working with the federal branch and/or Congress ; or 5+ years diverse background in the pharmaceutical industry, with at least 5 years in government affairs required
+ Bachelor's degree required. Advanced degree in law, health policy or MBA preferred
+ Ability to effectively deliver information, and explain, advocate and negotiate positions and issues to a broad spectrum of individuals required
+ Strong work ethic with ability to handle a fast-paced, vigorous schedule; comfortable with shouldering and assessing risk.
+ In depth understanding of healthcare, pharmaceutical and biotechnology industry issues required
+ Demonstrated track record of strong advocacy and communication skills
+ Ability to forge consensus, take others' viewpoints into account, and work as part of a team
+ Strong organizational, planning, strategic thinking, and people management skills
+ Independent thinker who can diplomatically and articulately present ideas that may be different from the prevailing or conventional views
+ Experience working with diverse coalitions and adeptness in developing and facilitating strategy across a network of internal and external partners
**Disclaimer**
This is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
**Equal Opportunity Employer**
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $164,530.00 - Maximum $245,985.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
$164.5k yearly 60d+ ago
Associate Director, Field Strategy, Nephrology
Otsuka America Pharmaceutical Inc. 4.9
Springfield, IL jobs
**Associate Director, Field Strategy, Nephrology/Immunology** The **Associate Director, Field Strategy** plays a critical role in enabling **sales execution** by ensuring that field teams have the **clarity, insights, and tools** needed to drive performance. This role is responsible for aligning **key metrics and insights** **with brand strategy** , ensuring that analytics dashboards and reporting tools provide **actionable, field-relevant intelligence** - ensures insights are turned into action.
Rather than creating new tools, data, or systems, this individual **orchestrates the seamless integration and application** of existing resources, ensuring field teams can focus on **flawless execution of sales strategy** . They ensure field teams are fully informed, equipped, and leveraging all available tools, insights, and strategic initiatives to maximize impact.
This position provides **strategic support across multiple regions** , partnering closely with **sales leadership nationwide** to ensure a broad perspective on **performance trends and execution effectiveness** . Additionally, the role collaborates with **Business Analysis team** to ensure field teams have access to **actionable insights and a consistent reporting framework** that drives informed decision-making at a national, regional, and territory level.
**Key responsibilities:**
+ **Define & Measure Field Impact:**
+ Establish **KPIs** that align with brand strategy to measure the field's effectiveness in driving business outcomes.
+ Develop **frameworks** to assess whether field teams are successfully executing strategic priorities
+ **Standardize Performance Tracking & Reporting**
+ Ensure **consistency in national and subnational tracking** of field performance and execution through standardized dashboards.
+ Partner with Commercial Operations to **streamline reporting processes** and provide clear, actionable insights
+ **Drive Strategic Clarity and Field Engagement & Execution**
+ Ensure that **brand strategy is effectively translated into field execution** , with clear expectations at the national, regional, ecosystem, and territory levels
+ Act as a strategic partner to sales leadership, ensuring that field insights inform future strategic decisions
+ Ensure field teams understand the **"why" behind initiatives** , fostering strong alignment with broader commercial objectives.
+ **Lead Business Review Framework & Execution**
+ Own the **business review process framework** , ensuring a standardized approach that addresses key strategic questions from senior leadership.
+ Develop clear templates and storytelling approaches to ensure **business reviews provide meaningful insights and drive decision-making**
+ **Support Business & Account Planning**
+ Ensure that **business and account plans are created effectively** and that key stakeholders (e.g., SBDs, ELs, HSAs) are accountable for execution.
+ Monitor plan execution and provide feedback to optimize performance at all levels
+ **Compliance Management:**
+ Must comply with all state and federal laws, regulations and guidelines including PhRMA Code on Interactions with Healthcare Professionals as well as complying with all OAPI standards and policies relating to all job activities
**Qualifications**
+ Bachelor's degree required; MBA or advanced degree preferred.
+ Minimum of 7 years of pharmaceutical experience
+ Prior experience in field leadership roles such as first or second line leadership, regional operational and customer strategy roles or other field-based support roles preferred
+ Proven experience in data analysis, business intelligence, and strategic planning within a pharmaceutical sales environment
+ Strong ability to distill data into concise, actionable insights to drive business performance
+ Excellent communication and stakeholder engagement skills, with the ability to influence and align across multiple teams
Proven ability to collaborate with cross
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $153,700.00 - Maximum $229,770.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
$153.7k yearly 60d+ ago
Associate Director, Global Product Quality-Controlled Substances
Otsuka America Pharmaceutical Inc. 4.9
Springfield, IL jobs
The Associate Director Controlled Substances, Quality Global Product Quality - API/DP is responsible for directing quality oversight of clinical and commercial controlled substances manufactured at CMOs under contract by Otsuka. This role is responsible to ensure that clinical and commercial products that may be classified as controlled substances are manufactured, packed, labelled, stored, and transported accordance with regulatory expectations and applicable cGMP/GDP quality standards. This role has global responsibility for directing clinical and commercial product quality to ensure global supply for Otsuka's patients. This role will also work collaboratively with other functional departments across Otsuka Affiliates and Subsidiaries to maintain the effectiveness of the Otsuka Quality Systems that support OPDC-sponsored clinical studies as well as drive continuous improvement.
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+ Responsible for directing quality oversight of GMP contract manufacturers of controlled substances for Otsuka clinical and commercial products
+ Support cross-functional teams to ensure alignment and compliance with controlled substance regulations.
+ Provides guidance and expertise to sites and business units to assess the facilities, and/or business operations, compliance of DEA regulations and site procedures.
+ Managing, updating and improvements of corporate controlled substance oversight standards. Provide oversight to ensure inspections readiness.
+ Establishes and maintain the effectiveness of Quality Systems for managing the batch record review and release process Quality Management Activities supporting all phases of clinical development as well as Commercial Product (API, drug product, and final finished product) for controlled substances
+ Works collaboratively within the Global Quality Dept. and other functions within OAPI and OPDC to assure Compliance to ensure continuous improvement and compliance
+ Establishes and maintains Standard Operating Procedures, work instructions, forms, templates and other documents associated with the systems noted above Improves supplier quality performance for batch record review and release process for
+ OAPI GMP release of Contract Manufacturers operations supporting clinical and commercial products.
+ Interfaces with Contract Manufacturers/Laboratories, Tech Ops, Technical Services and Supply Chain Sourcing to drive Quality improvements that minimize the Costs of Quality, specifically component, materials or finished product deviations, OOS incidents, rejects, etc.
+ Represents global quality during execution of product technical transfer activities to ensure all aspects of the transfer are conducted per cGMP
+ Assists in conducing audits of Contract Manufacturers/Laboratories (as part of an audit team) to ensure compliance with OAPI and OPDC requirements as well as applicable controlled substance regulatory requirements
+ Responsible for reviewing, drafting, and augmenting existing Quality agreements with external service providers to assure that full compliance and best practices as identified by Otsuka are communicated and continuously met
**Qualifications**
Required
+ Bachelor's degree in Chemistry, Biology or other Physical Sciences
+ Ten years of combined and/or pharmaceutical manufacturing, QA or QC assurance roles managing and directing quality oversight of commercial and development controlled substances.
+ Seven years of product quality experience performing batch review and release activities of suppliers or contract manufacturers or equivalent preferred supporting commercial products and/or development projects.
+ Expertise in conducting root cause investigations and driving CAPA implementation
+ Ability to supervise multiple direct reports and projects in a fast-paced environment
+ Demonstrated success in working on and leading cross functional teams
+ Experience with Pre Approval Inspections for NDAs
+ Experience in driving continuous improvement projects
+ TrackWise Experience
+ Excellent interpersonal and communication skills
+ Position requires approximately 20% domestic travel; Occasional international travel may also be expected.
Preferred
+ Advanced degree in Chemistry or other Physical Sciences
**Disclaimer**
This is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $150,034.00 - Maximum $224,250.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
$150k yearly 44d ago
Associate Director, GxP Training (Princeton, Hybrid)
Otsuka America Pharmaceutical Inc. 4.9
Springfield, IL jobs
The Associate Director, GxP Training, is a critical member of the Learning Center of Excellence within Global Quality. This role is responsible for developing and maintaining robust training programs that ensure compliance with Good Practice (GxP) regulations across the organization. The position will lead the design, implementation, and governance of global learning strategies that support regulatory readiness, operational excellence, and a strong quality culture.
**Key Responsibilities:**
+ **Learning Strategy & Governance**
+ Define and execute the global GxP training strategy in alignment with regulatory requirements and corporate quality objectives.
+ Establish governance frameworks for training compliance, including policies, procedures, and audit readiness.
+ **Program Development & Delivery**
+ Design and oversee GxP training programs for diverse functions (e.g., R&D, Manufacturing, Quality, Clinical, and Commercial).
+ Develop innovative learning solutions leveraging adult learning principles, digital platforms, and blended learning approaches.
+ **Compliance & Risk Management**
+ Ensure all training programs meet global regulatory standards (FDA, EMA, ICH, etc.) and internal SOPs.
+ Monitor training compliance metrics and proactively address gaps to mitigate regulatory risk.
+ **Stakeholder Collaboration**
+ Partner with functional leaders, Quality Systems, and HR to align training initiatives with business needs.
+ Serve as a subject matter expert on GxP learning during audits and inspections.
+ **Continuous Improvement & Analytics**
+ Define KPIs and utilize data analytics to measure training effectiveness and drive continuous improvement.
+ Stay current with regulatory changes, industry trends, and emerging technologies to evolve training programs.
**Qualifications:**
+ Bachelor's degree required; advanced degree in Life Sciences, Education, Organizational Development, or related field preferred.
+ 8+ years of experience in learning and development, preferably within the pharmaceutical, biotech, or healthcare industry with a focus on GxP compliance and training.
+ Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA, EMA, etc.).
+ Proven ability to design and deliver impactful learning programs using adult learning principles.
+ Experience with learning technologies (e.g., LMS, virtual learning platforms) and data-driven training strategies.
+ Expertise in instructional design, adult learning principles, and digital learning technologies.
+ Excellent communication, stakeholder management, and project leadership skills.
**Preferred Attributes:**
+ Strategic thinker with a passion for scientific learning and development.
+ Agile and adaptable in a fast-paced, matrixed environment.
+ Strong project management and organizational skills.
+ Committed to fostering innovation, compliance, and continuous improvement through learning.
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $146,955.00 - Maximum $219,650.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
$147k yearly 43d ago
Associate Director, Global Product Quality - Biologics
Otsuka America Pharmaceutical Inc. 4.9
Springfield, IL jobs
The Associate Director, Global Product Quality - Biologics is responsible for directing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable cGMP/GDP quality standards. This role will direct Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for directing clinical and commercial product quality to ensure global supply for Otsuka's patients. This role will also work collaboratively with other functional departments across Otsuka Affiliates and Subsidiaries to maintain the effectiveness of the Otsuka Quality Systems that support OPDC-sponsored clinical studies as well as drive continuous improvement.
****
+ Responsible for directing quality oversight of GMP contract manufacturers of Otsuka clinical and commercial products.
+ Develops comprehensive quality strategies for complex biologic development programs that address unique manufacturing challenges.
+ Establishes and maintain the effectiveness of Quality Systems for managing the batch record review and release process Quality Management Activities supporting all phases of clinical development as well as Commercial Product (API, drug product, and final finished product).
+ Transforms biologic manufacturing quality challenges through innovative approaches that maintain product integrity while optimizing operational efficiency.
+ Works collaboratively within the Global Quality Dept. and other functions within OAPI and OPDC to assure Compliance to ensure continuous improvement and compliance.
+ Manages reports and trends to the Management Representative to help in the preparation of Management reviews and/or other ad hoc reporting requests.
+ Establishes and maintains Standard Operating Procedures, work instructions, forms, templates and other documents associated with the systems noted above.
+ Improves supplier quality performance for batch record review and release process for OAPI GMP release of Contract Manufacturers operations supporting clinical and commercial products.
+ Interfaces with Contract Manufacturers/Laboratories, Tech Ops, Technical Services and Supply Chain Sourcing to drive Quality improvements that minimize the Costs of Quality, specifically component, materials or finished product deviations, OOS incidents, rejects, etc.
+ Represents global quality during execution of product technical transfer activities to ensure all aspects of the transfer are conducted per cGMP.
+ Assists in conducing audits of Contract Manufacturers/Laboratories (as part of an audit team) to ensure compliance with OAPI and OPDC requirements as well as applicable regulatory requirements.
+ Responsible for reviewing, drafting, and augmenting existing Quality agreements with external service providers to assure that full compliance and best practices as identified by Otsuka are communicated and continuously met.
+ Serves as a Global Quality Product Champion with a focus on ensuring the quality of our biologics products, monitoring, and escalation of any situations with potential negative impacts on clinical study supplies, supply chain for commercial products, or patient safety.
**Qualifications**
Required
+ Bachelor's degree in Chemistry, Biology or other Physical Sciences.
+ Ten years of combined and/or pharmaceutical manufacturing, QA or QC assurance roles managing and directing quality oversight of commercial product and development project activities.
+ Seven years of product quality experience performing batch review and release activities of suppliers or contract manufacturers or equivalent preferred supporting commercial products and/or development projects.
+ Proven experience with biologics GMP manufacturing, including upstream (cell culture, bioreactors) and downstream (purification, filtration, formulation) processes.
+ Expertise in conducting root cause investigations and driving CAPA implementation.
+ Ability to supervise multiple direct reports and projects in a fast-paced environment.
+ Demonstrated success in working on and leading cross functional teams.
+ Experience with Pre Approval Inspections for NDAs and BLAs.
+ Experience in driving continuous improvement projects.
+ TrackWise Experience.
+ Excellent interpersonal and communication skills.
+ Position requires approximately 20% domestic travel; Occasional international travel may also be expected.
Preferred
+ Advanced degree in Biology or other Physical Sciences.
+ Experience with quality oversight of controlled substances.
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $146,955.00 - Maximum $219,650.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
$147k yearly 60d+ ago
Associate Director, Commercial and G&A Training (Princeton, Hybrid)
Otsuka America Pharmaceutical Inc. 4.9
Springfield, IL jobs
The Associate Director will serve as a key member of the Learning Center of Excellence within Global Quality, responsible for designing, implementing, and sustaining high-impact training programs for Commercial and General & Administrative (G&A) functions. This role ensures that learning strategies align with regulatory requirements, corporate standards, and business objectives, fostering a culture of compliance, quality, and continuous improvement across global operations
**Key Responsibilities:**
+ **Learning Strategy & Design**
+ Develop and execute a comprehensive training strategy for Commercial and G&A teams in alignment with Global Quality standards and business priorities.
+ Partner with functional leaders to identify learning needs, compliance gaps, and performance improvement opportunities.
+ **Program Development & Delivery**
+ Design engaging, scalable, and compliant learning solutions (e.g., instructor-led, virtual, e-learning) tailored to diverse audiences.
+ Oversee the creation and maintenance of training content, ensuring accuracy, relevance, and adherence to regulatory guidelines.
+ **Governance & Compliance**
+ Ensure all training programs meet global regulatory requirements and internal quality standards.
+ Monitor training effectiveness and maintain audit-ready documentation for inspections.
+ **Stakeholder Engagement**
+ Collaborate with cross-functional teams, including Commercial, HR, Legal, and IT, to drive adoption and continuous improvement of learning initiatives.
+ Act as a trusted advisor to senior leadership on training trends, compliance risks, and capability-building strategies.
+ **Metrics & Continuous Improvement**
+ Define KPIs and leverage data analytics to measure training impact and drive enhancements.
+ Stay current with industry best practices, emerging technologies, and regulatory changes to evolve learning programs
**Qualifications:**
+ Bachelor's degree required; advanced degree in Life Sciences, Education, Organizational Development, or related field preferred.
+ 8+ years of experience in learning and development, preferably within the pharmaceutical, biotech, or healthcare industry.
+ Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA, EMA, etc.).
+ Proven ability to design and deliver impactful learning programs using adult learning principles.
+ Experience with learning technologies (e.g., LMS, virtual learning platforms) and data-driven training strategies.
+ Proven experience designing and implementing global training programs for Commercial and G&A functions.
+ Expertise in instructional design, adult learning principles, and digital learning technologies.
+ Excellent communication, stakeholder management, and project leadership skills.
**Preferred Attributes:**
+ Strategic thinker with a passion for scientific learning and development.
+ Agile and adaptable in a fast-paced, matrixed environment.
+ Strong project management and organizational skills.
+ Committed to fostering innovation, compliance, and continuous improvement through learning.
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $146,955.00 - Maximum $219,650.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.