Associate Director jobs at Astellas Pharma - 29 jobs

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.

#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. . 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. . 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?

As a senior leader within Medical Affairs, the Executive Director 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 Executive Director, 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 Executive Director 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.

**About Otsuka** We defy limitation, so that others can too. In going above and beyond-under any circumstances-for patients, families, providers, and for each other. It's this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day. **Position Overview:** The Director of Field Strategy and Operations serves as the orchestrator of field strategy, ensuring that prioritization, stakeholder engagement, and execution are effectively aligned with brand strategy and enterprise objectives. This role provides leadership across multiple regions, enabling a holistic, enterprise-wide approach to field strategy and operational excellence. This role also partners closely with the Business Analysis team to ensure field teams have access to standardized dashboards and data-driven insights, supporting execution excellence and performance tracking. The Director will be the point of contacts for ad hoc analytics requests, ensuring field teams have the right data to make informed decisions, but will not be creating these reports themselves or with their team and will work with Business Analysis to ensure accurate measurement and proper data is used. **Key Responsibilities:** + **Strategic Prioritization & Field Execution:** Align field activities with marketing strategy, launch planning, and market access pull-through, ensuring execution efficiency. + **Execution Excellence & Field Performance Tracking:** Oversee Omnichannel efforts, account planning, and KPI tracking, ensuring insights from Field Analytics support execution. + **Strategic prioritization & orchestrating field execution: Analyzes current and future state of the business based on insights and trends, and** leads efforts to align field activities with high-priority initiatives such as marketing strategy, launch planning, and market access pull-through. + **Field Communication & Data-Driven Decision Support:** Act as the primary field communicator, ensuring clarity on CRM tools, performance insights, and operational priorities. + **Resource Allocation & Budget Optimization:** Optimize the distribution of budgets, speaker programs, and promotional resources, leveraging data-driven insights to maximize ROI. + **Team Development & Analytics Training:** Mentor team members on business reviews, reporting systems, and analytics interpretation, working with Business Analysis to enhance field intelligence capabilities. + **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 10 years of pharmaceutical experience, with a strong understanding of sales force operations and execution. + 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 required. + Established expertise in business analytics, business operations, sales support, and resource management within a commercial pharmaceutical organization. + Ability to focus on priorities and resolve operational issues effectively. + Excellent communication and collaboration skills, with the ability to work cross-functionally and drive execution efficiency. **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 $194,247.00 - Maximum $290,375.00, 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.

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.

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. **** **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.

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. **** + 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.

The Associate Director, Strategic Planning & Operations will support the assets of varying lifecycle stages in the relevant therapeutic area portfolio. This role is crucial in driving operational excellence and innovation within our Global Medical Affairs organization, with a specific focus on the relevant therapeutic area programs. The successful candidate will play a pivotal role in shaping and implementing best practices and ensuring efficient medical affairs processes are in place. This position reports directly into the Director, Strategic Planning Lead, who in turn reports into the Medical Excellence & Operations Lead. **** **Key Responsibilities Include:** **Strategic Planning & Execution** + Develop and implement strategic plans in partnership with Medical Strategy leadership to enhance operational efficiency and effectiveness within the GMA organization for the relevant therapeutic area portfolio + Collaborate with cross-functional teams to align global medical operations with overall business objectives and therapeutic area strategies + Act as point lead (in collaboration with commercial) to coordinate annual medical/brand plans for the relevant therapeutic area portfolio + Drive long-term planning for the CNS portfolio by managing a 1 to 3-year roadmap that supports strategic decision-making and cross-functional collaboration + Oversee end-to-end program management processes, including planning, tracking, and reporting across key initiatives **Operational Efficiency and Process Improvement** + Identify opportunities for process improvement and lead initiatives to streamline GMA operations worldwide + Implement and optimize systems and tools to enhance productivity and data management within GMA + Develop and track key performance indicators (KPIs) to measure the effectiveness of global medical operations + Consider technology and AI to support workflow improvement **Cross-functional Collaboration** + Foster strong partnerships with Global Clinical Development, Global R&D Evidence, Commercial teams, & finance to ensure alignment and efficiency in medical activities + Collaborate with IT and digital teams to implement and optimize technology solutions for global medical operations + Serve as a liaison between Global Medical Affairs and other departments to facilitate smooth operations and communication across regions **Budget Management** + Develop and manage day to day aspects of budgets for global medical operations initiatives + Ensure cost-effective utilization of resources while maintaining high-quality outputs across all regions + Serve as a strategic thought partner who confidently challenges investment decisions, ensuring alignment with broader organizational strategy and long-term value creation + Foster a culture of continuous improvement of fiscal stewardship within the global team **Qualifications** **Education and Experience:** + Bachelors degree required, advanced degree in life sciences, pharmacy, or related field (Ph.D., PharmD) a plus + Minimum of 7 years of experience in Global Medical Affairs within the pharmaceutical or biotechnology industry, with at least 3 years in operational roles + Proven track record in implementing process improvements and driving operational excellence on a global scale **Skills and Competencies:** + Strong understanding of Global Medical Affairs functions and their interconnections with other departments + Technical knowledge in Veeva CRM, Veeva Vault, KOL Mapping Systems, etc. + Excellent project management skills with the ability to manage multiple global initiatives simultaneously + Strong leadership skills with the ability to influence without direct authority across global teams + Exceptional communication and interpersonal skills, with the ability to work effectively in a multicultural environment + Innovative mindset with the ability to identify and implement creative solutions for global challenges **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.

**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.

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.

The Associate Director of Global Supplier Quality will be responsible for the execution of supplier quality audit and monitoring across the company's global network of contract manufacturing organizations (CMOs). This role supports the qualification, monitoring, and compliance of external manufacturing partners to ensure the quality and reliability of pharmaceutical products, including small molecules and biologics. **** + **Supplier Quality Execution** + Support the qualification and ongoing monitoring of CMOs and critical suppliers. + Execute supplier audits and ensure timely follow-up and resolution of findings. + Maintain and update quality agreements in collaboration with internal stakeholders. + Conduct risk assessments and support mitigation plans for supplier-related quality issues. + **Compliance & Documentation** + Ensure supplier compliance with global regulatory requirements (e.g., FDA, EMA, ICH). + Prepare documentation and support internal and external audits and inspections. + Maintain accurate records of supplier performance and audit outcomes. + **Cross-Functional Collaboration** + Collaborate with Procurement, Manufacturing, Regulatory Affairs, and Technical Operations to ensure supplier quality is integrated into business processes. + Serve as a point of contact for operational supplier quality issues and escalations. + **Metrics & Reporting** + Track and report key performance indicators (KPIs) related to supplier quality. + Provide regular updates to leadership on supplier performance and compliance status **.** + **Team & Project Support** + May supervise or mentor junior quality staff or contractors. + Support continuous improvement initiatives within the supplier quality function. **Qualifications** Required + Bachelor's degree in a scientific or engineering discipline. + 6+ years of experience in pharmaceutical quality, with 2+ years in supplier or external manufacturing quality. + Strong knowledge of GMP regulations for small molecules and/or biologics. + Experience conducting audits and managing supplier documentation. + Strong communication and problem-solving skills. + Ability to travel internationally as needed. Preferred + Experience working with global CMOs. + Familiarity with digital tools and systems for supplier management. + Exposure to regulatory inspections and remediation activities. **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.

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.

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. **** + 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.

**Company Background/Culture** Otsuka is a global healthcare company with the corporate philosophy: "Otsuka people creating new products for better health worldwide." Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for maintenance of everyday health. In pharmaceuticals, Otsuka focuses on the development and commercialization of therapies in the challenging areas of Neuroscience, Nephrology, and Immunology in addition to research programs in various unmet specialty disease areas. **Culture** As a Company with a rich 100-year history, Otsuka is proud of its distinct culture that provides a competitive advantage. At Otsuka, we defy limitation, so that others can too, an attribute that reflects its Japanese heritage. Sozosei, meaning "creativity", gives Otsuka people permission to do what's never been done and can only be done by Otsuka. Every day is a new chance to invent and to create so that we can provide answers to medical needs that have yet to be addressed. Another Japanese tenet, Jissho-Shugi, means "earning responsibility by proving that you can deliver results consistently. Prove what you can do with small responsibilities and then move on to bigger responsibilities." Otsuka people are encouraged to push themselves far beyond expectations. To dream the impossible and make it a reality. By living the principles of Jissho (self-actualization), individuals and teams can achieve unprecedented outcomes that ultimately lead to greater responsibility. **Pipeline** Since 2007, OPDC has dedicated itself to the research and clinical development of products that could have a major impact on human health. OPDC develops promising drug candidates, starting with clinical trial management, and then planning the strategy for drug approval, and life cycle management to maximize a product's full potential. There are numerous compounds currently in the pipeline. In conjunction with Otsuka America Pharmaceutical, Inc., (OAPI), Otsuka has global strategies in place for the registration of their products. You can learn more about Otsuka by clicking here! (******************************************* **** **Position Summary** Otsuka is seeking an experienced and visionary Senior Director, Global Clinical Development (GCD), with experience in immunology, who will serve as a clinical leader responsible for the design, execution, and oversight of global clinical development programs. The successful candidate will play a key role in shaping the clinical strategy, leading cross-functional study teams, and ensuring the highest standards of scientific and medical integrity. The incumbent will be responsible for the design and oversight of clinical research programs and protocols for OPDC products under good clinical practices (GCP). The Senior Director, GCD works in a multidisciplinary matrix environment and supports the further development and commercialization of pharmaceutical products, for global launches. This position requires deep understanding of all aspects of the drug development process from early clinical stages to post commercialization, with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director, GCD is responsible for all the clinical development activities for the projects assigned and for the successful implementation and completion of trials leading to NDA, BLA, and/or Global filings. **Key Job Responsibilities** + Lead the clinical development strategy and execution for assigned programs after proof of concept through late-stage trials and regulatory submissions. + Provide medical and scientific leadership to cross-functional study teams and ensure high-quality clinical trial design, conduct, and data interpretation. + Serve as the medical lead and subject matter expert for assigned indications. + Partner with cross-functional team to ensure trials are conducted in compliance with GCP, regulatory requirements, and internal processes. + Lead and contribute to development of clinical sections of regulatory documents, including INDs, IBs, clinical study reports, and NDAs/BLAs. + Collaborate with regulatory affairs on interactions with global health authorities. + Provides strategic and medical oversight to vendor and CRO relationships and provides clinical input into their governance committees. + Lead clinical discussions with KOLs and advisory boards. + Develop clinical documents including medical monitoring plans, asset development plans + Contribute to development of publication plans and review scientific manuscripts for publications. + Mentor and provide leadership to junior team members within the organization. + Support business development activities through medical due diligence and evaluation of external opportunities. + Contributes to corporate initiatives by participating in continuous process improvement to meet company **Knowledge, Skills, Competencies, Education, and Experience** Required: + A clinician (M.D., or D.O.) preferably with an immunology, rheumatology, or dermatology background including management experience (direct or indirect). Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.) are a plus. In exceptional circumstances, highly qualified candidates with other clinical/scientific doctorates (e.g. D.M.D., D.D.S., Pharm.D., Psy.D., D.V.M., or Ph.D. may be considered if complemented by a team or consulting clinician. + Experience in the pharmaceutical industry, clinical practice experience and/o academic translational clinical research experience (as a general guideline minimum of five years of clinical research experience, post academia). + Requires thorough knowledge of clinical medicine and/or clinical pharmacology and associated disciplines (e.g. biostatistics, data management, medical writing). + An advanced understanding of clinical medicine and science. + Advanced understanding of drug development principles and clinical trial implementation and management. + Complete understanding of the global regulatory requirements. + Working knowledge of marketing and commercialization. + Complete understanding of overall corporate goals with a fundamental grasp of basic principles to work in a business setting. + Demonstrated experience in all developmental phases including evaluation of pre-clinical or in-licensing candidates' potential for meeting an unmet medical need, establishing early clinical safety and proof of concept, conduct of global trials for registration, and implementation of late-stage life-cycle management strategies, + Demonstrated experience in successfully leading clinical aspects of regulatory interactions; experience with a successful regulatory filing is a plus. + Ability to work across different therapeutic areas and different stages of clinical development. + Demonstrated ability to manage and motivate clinical team members (e.g., internal staff and external investigators/consultants). + Strong communication and presentation skills. + Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook). + Knows how/when to apply organizational policy or procedures to a variety of situations. + An advanced understanding of drug development principles and clinical trial implementation, management and reporting are essential and will be further developed, including: + Flexibility in working across different therapeutic areas and experience in different stages of clinical development. + Working knowledge of associated disciplines, including immunology, biostatistics, clinical pharmacology, formulation science, data management, and medical writing. + Complete understanding of the global regulatory requirements. Demonstrated experience in successful regulatory filings, while not essential, is an advantage. **Physical Demands and Work Environment** + Travel (~30-35%) + See document Physical Demands and Work Environment for further requirements. **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.

The Senior Director, Medical Communications, CNS directs and provides strategic leadership for the global and US scientific communication strategy for the assigned Central Nervous System (CNS) therapeutic area and product portfolio. This includes directing the development and dissemination of all core scientific and medical content (e.g., global slide decks, congress abstracts/presentations, publications, medical information, and medical education materials) to ensure scientific accuracy, consistency, and alignment with the overall CNS Medical Affairs strategy. The role is a key leadership position within the CNS Business Unit (BU) Medical Affairs team, influencing and engaging internal stakeholders, external experts, and the broader scientific community. **** **Key Responsibilities:** **Global Scientific Communication Strategy** + Define, direct, and oversee a comprehensive medical communications strategy and tactical plan for the CNS portfolio aligned to the overall medical strategy + Collaborate with the CNS Medical BU Lead and cross-functional teams (e.g., Global Integrated Evidence & Innovation, Clinical Development, Regulatory, Commercial) to ensure global and US alignment + Shape the scientific narrative for the therapeutic area, ensuring consistency across publications, congresses, and external engagements + Drive innovation in how scientific data is communicated, including digital transformation and real-time engagement models **Content Development Oversight** + Provide executive oversight for and ensure the strategic alignment of all CNS medical affairs communication materials, including but not limited to + Scientific Communications Platform (SCP) + Global Publications Strategy + Global Medical Publications Plan + Core Disease State Deck + Core Field Materials + Medical Publications + Integrated Medical Communications Planning + New Data Reporting + Medical Information Content Generation **Publications Strategy** + Direct strategic vision and ensure execution of the global publication plan for CNS assets, ensuring successful presentation of clinical data at major international congresses and in peer-reviewed journals + Direct agency and vendor relationships to deliver high quality publication deliverables **Congress Planning** + Set strategic priorities for congress participation and direct the planning and execution of Medical Affairs activities at major scientific congresses (e.g., booth content, symposia, internal debriefs) + Ensure coordinated scientific messaging and cross-functional alignment in close collaboration with Medical Excellence & Operations (ME&O) roles **Medical Information Content Generation:** + Oversee the creation, review, and approval of high-quality medical information content, including standard response letters, FAQs, global core content, and scientific response documents. + Ensure all content is scientifically accurate, evidence-based, and compliant with internal policies and external regulatory requirements. + Collaborate cross-functionally with Medical Affairs, Clinical Development, Regulatory, Legal, and Commercial teams to ensure consistency and alignment of messaging across channels. + Drive the development and implementation of content governance frameworks, version control processes, and global-to-local adaptation strategies. + Manage external vendors and medical writing agencies to ensure timely and high-quality content delivery. + Provide leadership and mentorship to a team of medical writers, content strategists, and reviewers, fostering a culture of excellence and continuous improvement. + Monitor and analyze content performance and stakeholder feedback to inform future content strategy and optimization. + Consider technology and AI to support workflow improvement **Cross-Functional Leadership** + Act as a thought leader and senior advisor on core CNS team meetings, aligning communication plans with CNS BU Medical Strategy and influencing enterprise-wide decisions + Partner closely with the US Field Medical Affairs Lead to ensure the field medical team is equipped with scientifically accurate, consistent, and compliant content aligned to US strategy + Support launch readiness for new indications or pipeline assets, including data dissemination and stakeholder education + Ensure all communication activities adhere to relevant company SOPs, GPP (Good Publication Practices), ICMJE guidelines, and global regulatory/legal requirements, establishing governance frameworks to ensure compliance across the function **Qualifications** **Education and Experience:** + Advanced scientific degree is required (PharmD, MD, PhD, or equivalent) with a strong understanding of clinical development and medical science, preferably in Neuroscience or a related CNS field + Minimum of 10 years of experience in Medical Affairs, Medical Communications, or Publication Planning within the pharmaceutical or biotechnology industry + Minimum of 5 years of progressive experience directing, developing, and providing executive leadership to a team of direct reports within a global communications function + Demonstrated track record of defining and directing enterprise-level global and/or US communication strategies for a marketed or late-stage development product, preferably in CNS therapeutic areas + Proven experience in managing complex budgets, directing large-scale initiatives, shaping workforce planning, and managing agency and vendor relationships on a global scale + Previous experience overseeing or leading medical information groups is a plus. **Skills and Competencies:** + Strong leadership and delegation skills, ability to manage performance, and foster a culture of scientific excellence and accountability at the departmental and cross-functional level + Superior skills in translating long-term business and clinical goals into actionable, measurable, and integrated medical communication strategies that influence enterprise-level decision-making + Demonstrated ability to manage multiple complex projects simultaneously, set clear priorities, and direct organizational processes to ensure operational excellence across varied functional responsibilities (publications, content, congress) + Excellent written and verbal communication skills, with the ability to influence and align senior leadership on complex scientific and strategic priorities while engaging cross-functional partners **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 $230,720.00 - Maximum $345,000.00, 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.

The Senior Director, Medical Communications, Nephrology & Immunology directs and provides strategic leadership for the global scientific communication strategy for the assigned Nephrology & Immunology therapeutic area and product portfolio. This includes directing the development and dissemination of all core scientific and medical content (e.g., global slide decks, congress abstracts/presentations, publications, medical information, and medical education materials) to ensure scientific accuracy, consistency, and alignment with the overall Nephrology & Immunology Medical Affairs strategy. The role is a key leadership position within the Nephrology & Immunology Unit (BU) Medical Affairs team, influencing and engaging internal stakeholders, external experts, and the broader scientific community. The role reports directly into the Executive Director, Nephrology & Immunology Business Unit Lead. **** **Key Responsibilities:** **Global Scientific Communication Strategy** + Define, direct, and oversee a comprehensive medical communications strategy and tactical plan for the Nephrology & Immunology portfolio aligned to the overall medical strategy (developed by the medical strategy team) + Collaborate with the Nephrology & Immunology BU Lead and cross-functional teams (e.g., Global Integrated Evidence & Innovation, Clinical Development, Regulatory, Commercial) to ensure global and US alignment + Shape the scientific narrative for the therapeutic area, ensuring consistency across publications, congresses, and external engagements + Drive innovation in how scientific data is communicated, including digital transformation and real-time engagement models **Content Development Oversight** + Provide executive oversight for and ensure the strategic alignment of all Nephrology & Immunology medical affairs communication materials, including but not limited to + Scientific Communications Platform (SCP) + Global Publications Strategy + Global Medical Publications Plan + Core Disease State Deck + Core Field Materials + Medical Publications + Integrated Medical Communications Planning + New Data Reporting + Medical Information Content Generation **Publications Strategy** + Direct strategic vision and ensure execution of the global publication plan for Nephrology & Immunology assets, ensuring successful presentation of clinical data at major international congresses and in peer-reviewed journals + Direct agency and vendor relationships to deliver publication deliverables **Congress Planning** + Set strategic priorities for congress participation and direct the planning and execution of Medical Affairs activities at major scientific congresses (e.g., booth content, symposia, internal debriefs) + Ensure coordinated scientific communication objectives and cross-functional alignment in close collaboration with Medical Excellence & Operations (ME&O) roles **Cross-Functional Leadership** + Act as a thought leader and senior advisor on core Nephrology & Immunology team meetings, aligning communication plans with Nephrology & Immunology BU Medical Strategy and influencing enterprise-wide decisions + Partner closely with the Global Field Medical Affairs Lead to ensure the global field medical team is equipped with scientifically accurate, consistent, and compliant content aligned to US strategy + Support launch readiness for new indications or pipeline assets, including data dissemination and stakeholder education + Ensure all communication activities adhere to relevant company SOPs, GPP (Good Publication Practices), ICMJE guidelines, and global regulatory/legal requirements, establishing governance frameworks to ensure compliance across the function + Consider technology and AI to support workflow improvement + Manage and mentor a team of medical writers and communication professionals, fostering excellence, innovation, and continuous development. **Qualifications** **Education and Experience:** + Advanced scientific degree is required (PharmD, MD, PhD, or equivalent) with a strong understanding of clinical development and medical science, preferably in a Nephrology & Immunology related field + Minimum of 10 years of experience in Medical Affairs, Medical Communications, or Publication Planning within the pharmaceutical or biotechnology industry + Minimum of 5 years of progressive experience directing, developing, and providing executive leadership to a team of direct reports within a global communications function + Demonstrated track record of defining and directing enterprise-level global communication strategies for late-stage assets and an emerging portfolio, preferably in Nephrology & Immunology therapeutic areas + Proven experience in managing complex budgets, directing large-scale initiatives, shaping workforce planning, and managing agency and vendor relationships on a global scale + Previous experience overseeing or leading medical information groups is a plus **Skills and Competencies:** + Strong ability to present to executive leadership team + Strong leadership and delegation skills, ability to manage performance, and foster a culture of scientific excellence and accountability at the departmental and cross-functional level + Superior skills in translating long-term business and clinical goals into actionable, measurable, and integrated medical communication strategies that influence enterprise-level decision-making + Demonstrated ability to manage multiple complex projects simultaneously, set clear priorities, and direct organizational processes to ensure operational excellence across varied functional responsibilities (publications, content, congress) + Excellent written and verbal communication skills, with the ability to influence and align senior leadership on complex scientific and strategic priorities while engaging cross-functional partners + Knowledge of digital platforms and tools for medical content delivery and engagement **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 $225,490.00 - Maximum $337,180.00, 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.

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:** + Provide global vision and strategic direction for establishing and validating clinical bioanalytical methods for PK, PD and immunogenicity across diverse modalities and biology, in close collaboration with the preclinical BA/BM group. + Testing and reporting in clinical studies in partnership with Clinical Operations and Data Management. + Develop and strengthen PK and biomarker bioanalysis capabilities by aligning strategy with operational feasibility to meet clinical development objectives. + Build and maintain effective working relationships with key internal stakeholders, including Clinical Pharmacology, Translational Medicine, and Modeling & Simulation/Pharmacometrics. + Meet or exceed all Astellas Development/ corporate goals for clinical study timelines/ deadlines. + Expand global bioanalysis capabilities across research and development functions, with a strong focus on collaboration with the preclinical BA/BM group. + Contribute to interaction with regulatory authorities related to Bioanalysis issues and registration. + Leadership position with direct reports. **Responsibilities and Accountabilities:** + To define, develop and lead the establishment of global bioanalysis standards that upon implementation, guarantee the generation and availability of appropriate Bioanalysis contributions across all phases of development and at registration + Responsible to implement biomarker/ PK activities within the majority of planned clinical studies. + Ensure that all activities associated with Bioanalytical work is documented and archived. + Responsible for interfacing and collaborating with key Research and Development functions + Responsible for optimal allocation and management of expertise and resources + At the project level, ensure that clinical tests are precise/ accurate and robust. These tests would satisfy regulatory bodies and would additionally follow local guidances. + Reports to Head, Translational & Biomedical Science + Have direct reporting PK and Biomarker Bioanalysis scientists who are responsible for providing contributions to individual projects + Staff from the section will work on 15 - 30 projects from P0 through registration. **Required** + Advanced degree (Ph.D. or equivalent) with at least 8 years experience in an industry setting, in drug research/development, with demonstrated track record of application of PK/ PD and biomarkers approaches across multiple modalities. + Demonstrated successful program leadership and multi-project coordination + Solid understanding of regulatory interactions with the FDA and other global regulatory agencies. + Ability to influence and deliver results in a cross-functional team environment with strong leadership. + Excellent written and verbal communication skills **Preferred** + Proven management experience with demonstrated leadership capabilities. + Experience in drug development for complex modalities such as bispecific antibody, ADC, cell therapy, mRNA, gene therapy. + Background in research activities and/or bioanalytical or analytical work, including hands-on experience in bioanalytical laboratory settings. + Have the ability to troubleshoot/ develop and validate novel bioanalytical methods for the measurement of drug, metabolites and biomarkers in collaboration with CROs/ academic collaborators + International recognition as an expert in the field. **Salary Range** $229,600 - $360,800 (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 Category Translational and Biomedical Science Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans