Radioligand Therapies (RLT) Associate Director, Priority Accounts - Tri- State
Novartis AG 4.9
Associate director job at Novartis
#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. .
As a Radioligand Therapies (RLT) AssociateDirector, Priority Accounts, you'll partner with Neuroendocrine Tumors (NET) Centers of Excellence and health care system sites to drive impactful engagement. This role focuses on creating and executing strategic business plans for key accounts while collaborating with cross-functional teams to deliver institution-centric programs aligned with business priorities and compliance standards. You'll lead commercial strategies, foster strong relationships with senior stakeholders, and provide operational and financial insights to uncover new opportunities. Success in this position calls for expertise in institutional selling, healthcare systems, access navigation, and collaborative problem-solving.
About the Role
Key Responsibilities:
* Champion institutional advocacy for the adoption of the Radioligand Therapies (RLT) and Neuroendocrine Tumors (NET) brand to support appropriate product utilization.
* Build strong partnerships with Neuroendocrine Tumors Centers of Excellence and health care system sites to drive impactful engagement.
* Develop, coordinate, and execute strategic business plans for priority accounts, ensuring alignment with market dynamics and organizational goals.
* Cultivate relationships with clinical, operational, and administrative decision-makers to streamline care pathways, treatment protocols, and workflow solutions.
* Stay informed on market trends, customer economics, and access models, including payment programs and reimbursement strategies.
* Share knowledge of Novartis' offerings and ensure account administrators have access to relevant resources, while maintaining compliance.
* Collaborate with local teams to create tailored, institution-specific plans that reflect local market forces and opportunities.
* Deliver approved product and disease state presentations to clinicians and staff, fostering trust and collaboration across key partners.
* Conduct periodic needs assessments to identify opportunities and communicate actionable insights to cross-functional partners.
* Support team members in diagnosing business challenges and implementing strategies that optimize outcomes for Radioligand Therapies and Neuroendocrine Tumors accounts and affiliated health systems.
Essential Requirements:
* Bachelor's degree required from 4-year college or university.
* 8+ years' experience in pharmaceutical, biotech, healthcare, or similarly structured industries with large, geographically dispersed field teams. We also welcome candidates from other complex 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 strong ability to collaborate and work cross-functionally in a matrix environment to build effective strategic account plans aligned to customer and organization goals.
* Candidate must reside within territory or reside in a territory adjacent to the assigned geography. Ability to travel 60-80% over a broad geography is required, with the ability to drive and/or fly within the territory. Must have a valid driver's license.
Desirable Requirements:
* Strong knowledge of the Radioligand Therapies (RLT) platform and experience representing Radioligand Therapies products, with a proven ability to drive adoption at scale.
* Cross-functional experience in areas such as Marketing, Medical, Market Access, Reimbursement, or Sales Leadership, and prior engagement with assigned accounts.
Driving is an Essential Function of this Role: Meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving.
COVID-19 Vaccine Policy (customer-facing roles only): While Novartis does not require vaccination for COVID-19 or proof of a recent negative test result for COVID-19 at this time, employees working in customer-facing roles must adhere to and comply with customers' (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to **********************************.
For Field Roles with a Dedicated Training Period: The individual hired for this role will be required to successfully complete certain initial training, including home study in eight (8) or fewer hours per day and forty (40) or fewer hours per week.
Novartis Compensation Summary:
The salary for this position is expected to range between: $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?
$160.3k-297.7k yearly 12d ago
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Associate Director, AI Tech Lead
Novartis AG 4.9
Associate director job at Novartis
is East Hanover, NJ. About the Role The Insights and Decision Science (IDS) team is dedicated to enabling improved decision making at Novartis by leveraging superior data, AI, and innovative technology to identify actionable insights that drive enhanced performance. We collaborate closely with the US business, bringing insights and challenging ideas to empower smarter, data-driven decision-making. Reporting into the Director, AI Technology, the AssociateDirector for AI Tech Lead is crucial in driving the strategic integration of artificial intelligence into our product offerings, enhancing our competitive edge in the pharmaceutical industry.
This position plays a pivotal role in identifying and leveraging emerging opportunities in generative and agentic AI to support the broader IDS goals. By leading the development and prototyping of AI-based solutions, the AD transforms innovative ideas into market-ready products that align with the company's strategic objectives. This individual will interact directly with business users and IDS team to showcase tech capabilities, translate requirements to innovative solutions and options, and aid in the development of architecture and roadmaps to support use case prototypes or projects to host products created by the Data Science Team.
Major Accountabilities
* Develop and maintain strong, trust-based relationships with US business partners and IDS team members to understand their business objectives and provide tailored AI solutions
* Translate business requirements and objectives into technical requirements needed to assess feasibility and support prototype development
* Build solutions and roadmaps for innovative projects, focusing on quick/agile rollout of tools, testing, and iterating plans to improve and launch quickly
* Create detailed design frameworks that define how the application will be structured and how components will interact tools to support scalability and integration with existing platforms and systems
* Contribute credible insights to strategic reviews and analysis and apply whole market perspective to enable deep customer understanding
* Own the development of solution architecture to support use case prototypes
* Collaborate with a diverse team of individuals to pull-through solution roadmap and oversee the development of AI prototypes
* Support testing/UAT testing from key users / stakeholders across the business
* Ensure the prototype addresses key business questions such as improving patient outcomes or enhancing manufacturing processes
* Oversee rapid testing of PoC and MVP builds to reduce risk before full development
* Able to clearly articulate the potential benefits of AI models to address business needs with a wide range of audiences, including lay audiences
* Acts as an AI role model, championing a culture that embraces cutting-edge AI technologies and encourages experimentation and adoption of best practices
Experience:
Novartis seeks an experienced leader with have a proven track record in successfully building product prototypes, with a strong ability to engage with key stakeholders to gather and incorporate feedback. A deep understanding of how AI solutions can address critical business challenges, such as enhancing patient outcomes and optimizing research and development processes, is essential. The candidate should be adept at comprehensive design blueprints
Experience:
Novartis seeks an experienced leader with have a proven track record in successfully building product prototypes, with a strong ability to engage with key stakeholders to gather and incorporate feedback. A deep understanding of how AI solutions can address critical business challenges, such as enhancing patient outcomes and optimizing research and development processes, is essential. The candidate should be adept at comprehensive design blueprints and seamless integration of AI technologies. A commitment to driving continuous improvement in AI solutions, informed by data insights and industry trends, is vital to this role.
Additional qualifications are as follows:
* A bachelor's degree in related field is required; Master of Science and/or MBA preferred
* 6-8 years of experience in tech development in the healthcare industry, including full-stack development experience
* Extensive experience building relationships with stakeholders to translate AI and technology innovations into business value
* Highly proficient in building AI product prototypes, working in conjunction with data science teams
* Demonstrated ability to oversee the entire AI product development process, with experience creating solution roadmaps
* Strong data analytics, AI, and machine learning background
* Strategic planning capability combined with an outstanding ability to drive execution with a focus on directing operational enhancements to increase quality and effectiveness
* Proven teamwork, collaboration, and people management skills
* Ability to work in a dynamic, fast-paced, multifunctional environment
* Strong communication skills and experience explaining highly technical information to a wide range of audiences
The pay range for this position at commencement of employment is expected to be between: $126,000.00 and $234,000.00 a year; however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
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?
$126k-234k yearly 60d+ ago
Associate Director - Regional Clinical Research Lead
Eli Lilly and Company 4.6
Remote
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Purpose:
The Regional Clinical Research Lead (rCRL) leads the execution of clinical trials across a country/region/ globally for complex and high priority programs to enable global clinical trial delivery. The rCRL anticipates, mitigates and resolves risks to ensure timely delivery of clinical trial enrollment across the country / region(s) / globe. The rCRL is responsible to identify and execute process improvement opportunities using their understanding of cross functional interdependencies to enable end to end delivery of clinical programs. This rCRL role is based in and responsible for the United States region with a focus on Cardiometabolic Health (CMH) therapeutic areas.
Primary Responsibilities:
Clinical Trial Leadership
Accountable to gather the insights and represent the geographical complexity and leads the coordinated effort for delivery of large, complex and high priority programs within countries / regions / globally
Leverage deep expertise in regional trial execution to represent Investigator Engagement in cross functional clinical trial forums. Recognized as a Leader in Clinical Development, influencing study design and delivery and leads initiatives to drive improvements and deliver the portfolio
Anticipate, mitigate and resolve complex and key operational risks, driving to enable timely delivery of clinical trial enrollment commitments and database locks across a country/region or portfolio
Regional Leadership for inspection preparation and management. Proactively identify and drive for inspection readiness at all times.
Leverage deep scientific and disease expertise within a TA (s), understand regional and local treatment paradigms and patient access mechanisms to influence platform/protocol decisions to enable reliable enrollment and implementation.
Use insights from a broad range of sources including vendor oversight, best practices and metrics to identify and deliver functional process improvements.
Utilize strategic knowledge of the Lilly portfolio and priorities to lead targeted prospecting and anticipate future needs for Investigator engagement.
Clinical Investigator Management:
Leads CRLs in comprehensive Investigator management activities, including Investigator identification, qualification and selection, enrollment readiness, planning and execution through to database lock and close out for complex trials and portfolios across a country/region. Ownership for key hospitals / institutions / networks
Independently detects and leads potential opportunities to accelerate trial enrollment across a country/region/ globally. Proactively identifies risks and implements mitigations to ensure Investigator performance and Clinical Trial delivery
Leverages deep scientific, therapeutic area, and institutional/regional expertise to engage in scientific discussions with the investigator and institution personnel within a country / region
Owns strategic institutional/ Investigator relationships to optimize the delivery of clinical trial programs, including across therapeutic areas where applicable
Business Management and External Influence:
Lead across portfolio / program to establish and develop strong professional relationships to expand/maintain clinical research partnership opportunities
Understand cross functional interdependencies and identify opportunities for collaboration and process improvement, enabling end to end delivery of clinical programs
Drive required interactions between external and internal partners (inclusive of affiliate and regional interactions and initiatives as applicable)
Identify long and short-term customer, competitive and environmental trends and develop solutions to meet changing needs of customers and the business
Identify and lead mechanisms for sharing of technical, scientific, and operational expertise with a broad focus to build Investigator Engagement capability and knowledge within the CDDA
Coach & mentor roles within the CDDA organization
Engage with Regulatory bodies, Ethical Review Boards, and other relevant external bodies to influence and challenge internal and external factors shaping clinical trial execution. Ensure internal processes and procedures reflect and comply with country requirements.
Influence internal and external customers/partners to identify opportunities and implement strategies for improving technologies, processes, products, and services.
Minimum Qualification Requirements:
Bachelor's degree or equivalent in a scientific or health-related field
Minimum of 5 years' experience in the pharmaceutical industry and/or clinical research, including 3 years as a CRL (or equivalent role) and strong working knowledge of Good Clinical Practice
Deep therapeutic expertise and knowledge of the clinical research landscape; ability to acquire and maintain additional therapeutic expertise to support portfolio needs
Proficiency in country regulatory guidelines/requirements
Strong self-management and organizational skills; ability to manage workload, set personal priorities and adjust as needed
Demonstrated strategic agility & broad business acumen
Demonstrated leadership behaviors with ability to accept challenges, seek opportunities to remove barriers, influence without authority, and lead in areas of uncertainty
Other Information/Additional Preferences:
Strong communication (both verbal and written) and language skills to break down complexity into clear and concise messaging
Demonstrated ability to enhance/improve customer experience
Fluent in English as well as required language to conduct day-to-day business
Strong teamwork and interpersonal skills, including ability to work in cross-cultural teams
Demonstrated decision-making ability
Ability to identify, develop and implement creative solutions
Travel required (up to 50%)
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$115,500 - $204,600
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
$115.5k-204.6k yearly Auto-Apply 2d ago
Delivery Operations Head- Vaccines
Sanofi 4.3
Morristown, NJ jobs
Job Title: Delivery Operations Head- Vaccines
About the Job
Join the team protecting half a billion lives every year with next-gen science, mRNA innovation, and AI-driven breakthroughs. In Vaccines, you'll help advance prevention on a global scale - and shape the future of immunization.
The Marketing & Commercial Strategy team designs and executes customer-centric solutions to maximize the potential of our innovative vaccine portfolio and future pipeline. This goes beyond delivering best-in-class (BIC) and first-in-class (FIC) assets-it requires managing complex product operations and creating competitive customer experience advantages. The team comprises marketing, early commercial leadership, and product operations.
The Product Operations function provides a strategic edge by
embedding operational excellence into brand value propositions
and ensuring best-in-class customer experiences. The leader of this team is accountable for integrating product demand into global processes, managing partnerships with distribution networks, executing complex delivery requirements across the portfolio, and designing innovative delivery solutions. These efforts are critical to achieving the U.S. Vaccines budget and directly impact over $3B in annual revenue
About Sanofi:
We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.
Main Responsibilities:
Leadership & Team Management
Lead and develop a team of 7 employees, fostering a culture of accountability, collaboration, and continuous improvement.
Set clear goals, monitor performance, and provide coaching to ensure team success.
Operational Strategy & Execution
Collaborate with franchise teams to develop and embed operational excellence into brand value propositions for different customer segments like Public, Retail, Health systems and Independent
Define and implement enterprise-wide operational strategies that ensure timely, compliant, and cost-effective vaccine supply across all distribution channels, balancing financial stewardship with quality and regulatory requirements.
Lead and influence cross-functional teams-both directly and indirectly- to deliver innovative, scalable solutions that address current challenges and anticipate future organizational needs, ensuring alignment with corporate objectives, customer expectations, and budgetary constraints.
Drive end-to-end process optimization and operational scalability, enabling sustainable growth and supporting complex product launches in a dynamic, highly regulated environment.
Establish and enforce accountability frameworks across multiple business units, integrating fiscal responsibility into operational decision-making to ensure budget adherence, cost optimization, and risk mitigation under tight timelines and evolving market conditions.
Cross-Functional Collaboration
Forge strategic partnerships with Industrial Affairs, Brand Marketing, Sales, Customer Service, North America Distribution, Finance, and Executive Leadership to ensure operational plans are fully aligned with overarching business priorities and compliance requirements.
Serve as the primary operational liaison to commercial teams, driving seamless execution and accountability across multiple functions with competing priorities.
Establish governance frameworks that clarify roles, responsibilities, and decision-making authority, ensuring transparency and adherence to organizational objectives.
Navigate complex interdependencies between supply chain, commercial, and financial functions to mitigate risk, optimize performance, and deliver on time-sensitive commitments in a highly regulated environment.
Supply Assurance
Ensure uninterrupted product availability across all vaccine portfolios by proactively identifying risks, managing contingencies, and implementing mitigation strategies in a dynamic, highly regulated environment.
Oversee integrated inventory planning, demand forecasting, and distribution strategies, balancing global supply constraints, market variability, and compliance requirements to meet diverse customer needs.
Establish accountability frameworks for cross-functional teams, ensuring transparency in decision-making and alignment with financial, operational, and regulatory objectives.
Drive scenario planning and risk modeling to anticipate disruptions and maintain resilience across complex supply networks.
Governance & Reporting
Develop and maintain KPIs to monitor operational performance and supply chain health.
Provide regular updates to senior leadership on operational status, risks, and mitigation plans.
About You
Required Qualifications
Bachelor's degree in business, supply chain, or related field; advanced degree preferred.
10+ years of experience in operations, supply chain, or related roles, preferably in pharmaceuticals or vaccines.
A minimum of 5 years of progressive leadership/people management experience is required.
Experience working with global supply chain and manufacturing groups.
Proven leadership experience managing teams and driving cross-functional initiatives.
Strong analytical, strategic thinking, and problem-solving skills with experience developing operational value propositions for end customer groups
Excellent communication and stakeholder management abilities.
This position may require up to 30% overall business travel.
Preferred Qualifications:
Strategic Thinking: Ability to develop and execute long-term operational strategies aligned with business objectives.
Leadership: Proven capability to inspire, coach, and lead teams toward achieving ambitious goals.
Collaboration: Skilled in building strong relationships across diverse functions and influencing without authority.
Analytical Skills: Strong ability to interpret data, identify trends, and make informed decisions.
Adaptability: Comfortable navigating ambiguity and driving change in a dynamic environment.
Communication: Exceptional verbal and written communication skills for engaging stakeholders at all levels.
Problem-Solving: Ability to anticipate challenges and implement proactive solutions.
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
#GD-SP
#LI-SP
#LI-Onsite
#vhd
Pursue
progress
, discover
extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
North America Applicants Only
The salary range for this position is:
$159,750.00 - $230,750.00
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
$159.8k-230.8k yearly Auto-Apply 38d ago
Associate Director Quantitative Data Modeling
Sanofi 4.3
Morristown, NJ jobs
Job Title: AssociateDirector Quantitative Data Modeling About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.
The Quantitative Pharmacology (QP) organization at Sanofi is dedicated to ensuring the safe and effective therapeutic treatment of patients by applying sound pharmacokinetic (PK) and pharmacodynamic (PD) principles to accelerate and optimize drug development.
Within QP, the Pharmacometrics group employs Model-Informed Drug Discovery and Development (MIDD) approaches to support decision making throughout the drug development continuum. This includes guiding dose selection and study design, de-risking potential drug-drug interactions, quantifying benefit-risk relationships, and contributing to regulatory submissions and interactions from first-in-human studies through life-cycle management.
This position, based in Morristown, NJ, requires the successful candidate to be onsite three days per week. The AssociateDirector will play a key role in advancing Sanofi's internal pipeline across multiple therapeutic areas by conducting a broad spectrum of model-based analyses, spanning population PK and PK/PD modeling, disease progression modeling, and advanced methodologies such as data analytics, machine learning, and mechanistic modeling. The incumbent will contribute to data-driven decision making and the application of innovative modeling strategies with minimal supervision.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Main Responsibilities:
AssociateDirector is expected to be equipped with multifaceted quantitative expertise applied to drug development including:
* Ability to formulate drug development questions and develop modeling and simulation strategies for optimizing model-informed drug development in all stages of development, ranging from first in human dosing through life cycle management.
* Conduct with minimal supervision model-based analyses such as population pharmacokinetics (PPK), PK/PD, exposure response, model-based meta-analysis, clinical trial simulations and disease progression modeling to drive internal pipeline forward.
* Conduct innovative quantitative methodologies such as data analytics, machine learning and mechanistic modeling as needed.
About You
Required Experiences
* Strong quantitative skills including but not limited to mathematics, statistics, data science, AI/ML, etc.
* Deep and extensive experience with advanced population modeling approaches (e.g. PPK, PKPD, etc. ) and complex methodologies such data analytic, AI/ML and mechanistic modeling.
* Proficiency in conducting model-based analyses using standard pharmacometrics software (e.g., NONMEM, R, Monolix, etc.)
* Proficiency in integrating and analyzing internal and external data to support decision making and to generate scientific insights.
* Strong written and verbal communication skills, interdisciplinary collaboration, problem scoping and planning.
* Good knowledge of industry best practices, global regulatory, processes, standards of drug development.
Demonstrate the following scientific competencies:
* Serve as M&S representative for clinical development projects.
* Act as a subject matter expert addressing technical and theoretical issues in the M&S area.
* Be able to operate in a multicultural environment and participate in international teams.
* Prepare and issue stand-alone M&S reports with minimal review.
* Summarize documents for submission to regulatory agencies, including but not limited to the FDA and EMA
* Prepare abstracts, posters and manuscripts for external presentation and/or publication.
* Present at external scientific meetings as appropriate
* Identify skill-sets necessary to advance career development.
* Ensure that all assigned project activities are performed in compliance with current departmental SOP's, guidelines, industry best practices and regulatory guidelines, and are conducted following acceptable scientific rationale.
Qualifications
* Ph.D. with or without post-doctoral experience in pharmacometrics, biopharmaceutics, pharmaceutical sciences, mathematics, statistics, data science, computational biology, chemical/biomedical engineering, system pharmacology, computer science or closely related discipline plus at least 5 years of industrial experience with a record of increasing responsibility and independence
* Technical expertise in several of the following areas ranging from classic translational and population PK modeling, PK/PD modeling, exposure-response modeling, clinical trial simulation, drug-disease modeling, PBPK modeling, to advanced complex methodologies such as data analytics, machine learning and mechanistic modeling.
* Strong background in different M&S software such as NONMEM, R, Monolix, Phoenix NLME, PUMAS, Matlab, PKsim, SimCYP, SAS, Python, C/C++, Julia
* Excellent oral and written communication skills and strong problem-solving skills
Why Choose Us?
* Bring the miracles of science to life alongside a supportive, future-focused team.
* Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
* Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
* Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
#GD-SA
#LI-SA
#LI-Onsite
#vhd
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
North America Applicants Only
The salary range for this position is:
$148,500.00 - $247,500.00
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
$148.5k-247.5k yearly Auto-Apply 17d ago
Associate Director, Forecasting (Tzield -T1D)
Sanofi Group 4.3
Morristown, NJ jobs
**Job Title:** AssociateDirector, Forecasting (Tzield -T1D) **About the Job** Ready to push the limits of what's possible? Join Sanofi in one of our corporate functions, and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world. ** **
The AssociateDirector, Forecasting, will lead, create vision, and implement processes associated with patient-based specialty drug demand forecasts for the General Medicines business unit. The role will use in-depth knowledge and expertise to build and implement best-in-class forecast practices and procedures, ensuring timeliness and alignment with brand and business objectives. This role will lead forecasting efforts for core specialty and infusion products for US General Medicines, currently focused exclusively on Tzield.
**About Sanofi:**
We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.
**Main Responsibilities:**
+ Lead strategic brand forecast for core US General Medicines biologics products distributed through specialty and infusion (Currently Tzield).
+ Use in-depth knowledge of specialty drug forecasting to create vision and implement processes for patient-based specialty drug demand forecasts, ensuring accuracy, timeliness, and alignment to brand and business objectives.
+ Lead the process of synthesizing relevant market research, secondary analytics, and competitive data into guiding forecast assumptions.
+ Identify brand franchise risks and opportunities to demand and provide associated sensitivity analyses.
+ Proactively identify gaps in specialty forecasting capabilities and implement innovative solutions via systems, tools, and processes.
+ Be a key leader in the strategic brand planning process.
+ Lead scenario-based analyses to develop and inform strategies, mitigate risk, and take advantage of identified opportunities.
+ Facilitate and lead cross-functional collaboration with a vast array of stakeholders, including Marketing, Market Access, and Finance, to ensure coordinated assumptions to forecast (e.g., market events, pricing, and gross-to-net impacts, etc.)
+ Produce and deliver executive-level presentations to a local and global audience.
**About You**
**Requirements:**
+ Bachelor's degree in a relevant field. Advanced degree preferred.
+ 6+ years of analytical experience in the Biotech/Pharmaceutical industry, with significant time spent in specialty product forecasting.
+ Deep expertise in US specialty Rx forecasting. Rare disease and/or Immunology category experience strongly preferred.
+ Exceptional stakeholder management with a demonstrated ability to lead directly or through influence in a complex global matrixed environment.
+ Ability to interact, influence, and communicate with all levels in the organization.
+ Proactive mindset with the ability to lead through and embrace ambiguity without guidance.
+ In-depth knowledge of contemporary forecasting techniques, models, and approaches.
+ Hands-on skills - Excel, BI platforms, data visualization tools, niche forecasting platforms, etc.
+ Understanding of epidemiology data and concepts.
+ Financial literacy and high business acumen.
+ Relationship-oriented, cultivates good working relationships with peers and managers.
**Why Choose Us?**
+ Bring the miracles of science to life alongside a supportive, future-focused team.
+ Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or a lateral move, at home or internationally.
+ Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
+ Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs, and at least 14 weeks' gender-neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
\#GD-SG
\#LI-GZ
\#LI-Onsite
\#vhd
**Pursue** **_progress_** **, discover** **_extraordinary_**
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video (************************************************** and check out our Diversity Equity and Inclusion actions at sanofi.com (************************************************************************ !
_US and Puerto Rico Residents Only_
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
_North America Applicants Only_
The salary range for this position is:
$147,000.00 - $245,000.00
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (********************************************************************************************************* .
Global Terms & Conditions and Data Privacy Statement (***************************************************************
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting ************** or via our movie We are Sanofi (*****************************
As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (************************************************
$147k-245k yearly 38d ago
Associate Director, Forecasting (Tzield -T1D)
Sanofi 4.3
Morristown, NJ jobs
Job Title: AssociateDirector, Forecasting (Tzield -T1D) About the Job Ready to push the limits of what's possible? Join Sanofi in one of our corporate functions, and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world.
The AssociateDirector, Forecasting, will lead, create vision, and implement processes associated with patient-based specialty drug demand forecasts for the General Medicines business unit. The role will use in-depth knowledge and expertise to build and implement best-in-class forecast practices and procedures, ensuring timeliness and alignment with brand and business objectives. This role will lead forecasting efforts for core specialty and infusion products for US General Medicines, currently focused exclusively on Tzield.
About Sanofi:
We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.
Main Responsibilities:
* Lead strategic brand forecast for core US General Medicines biologics products distributed through specialty and infusion (Currently Tzield).
* Use in-depth knowledge of specialty drug forecasting to create vision and implement processes for patient-based specialty drug demand forecasts, ensuring accuracy, timeliness, and alignment to brand and business objectives.
* Lead the process of synthesizing relevant market research, secondary analytics, and competitive data into guiding forecast assumptions.
* Identify brand franchise risks and opportunities to demand and provide associated sensitivity analyses.
* Proactively identify gaps in specialty forecasting capabilities and implement innovative solutions via systems, tools, and processes.
* Be a key leader in the strategic brand planning process.
* Lead scenario-based analyses to develop and inform strategies, mitigate risk, and take advantage of identified opportunities.
* Facilitate and lead cross-functional collaboration with a vast array of stakeholders, including Marketing, Market Access, and Finance, to ensure coordinated assumptions to forecast (e.g., market events, pricing, and gross-to-net impacts, etc.)
* Produce and deliver executive-level presentations to a local and global audience.
About You
Requirements:
* Bachelor's degree in a relevant field. Advanced degree preferred.
* 6+ years of analytical experience in the Biotech/Pharmaceutical industry, with significant time spent in specialty product forecasting.
* Deep expertise in US specialty Rx forecasting. Rare disease and/or Immunology category experience strongly preferred.
* Exceptional stakeholder management with a demonstrated ability to lead directly or through influence in a complex global matrixed environment.
* Ability to interact, influence, and communicate with all levels in the organization.
* Proactive mindset with the ability to lead through and embrace ambiguity without guidance.
* In-depth knowledge of contemporary forecasting techniques, models, and approaches.
* Hands-on skills - Excel, BI platforms, data visualization tools, niche forecasting platforms, etc.
* Understanding of epidemiology data and concepts.
* Financial literacy and high business acumen.
* Relationship-oriented, cultivates good working relationships with peers and managers.
Why Choose Us?
* Bring the miracles of science to life alongside a supportive, future-focused team.
* Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or a lateral move, at home or internationally.
* Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
* Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs, and at least 14 weeks' gender-neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
#GD-SG
#LI-GZ
#LI-Onsite
#vhd
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
North America Applicants Only
The salary range for this position is:
$147,000.00 - $245,000.00
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
$147k-245k yearly Auto-Apply 39d ago
Associate Director, Data Science - Market Access
Sanofi 4.3
Morristown, NJ jobs
Job Title: AssociateDirector, Data Science - Market Access About the Job Join the team transforming care for people with immune challenges, rare diseases, cancers, and neurological conditions. In Specialty Care, you'll help deliver breakthrough treatments that bring hope to patients with some of the highest unmet needs.
Join Sanofi in one of our US Market Access Shared Services functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world. Work collaboratively with matrix partners to manage the strategic attainment of product access and appropriate reimbursement at key customers by participating in and overseeing the negotiation process of financial terms, as well as documented terms and conditions, for assigned customers.
About Sanofi:
We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.
Main Responsibilities:
As the AssociateDirector of Data Science, you will lead the development and delivery of advanced analytics solutions to support market access and pricing decisions. You will perform sophisticated analyses on patient longitudinal data, develop interactive dashboards and reports, and translate complex data into actionable insights for stakeholders. Your role will involve partnering with various departments to support strategic initiatives and leveraging analytics capabilities to enhance data-driven decision-making. Core responsibilities of the role are as follows:
* Design, develop, and deploy predictive models and analytical solutions using Dagster/Airflow and DBT workflows to drive data-informed market access and pricing decisions. Hands on experience with R and/or Python is required.
* Architect and maintain scalable datasets that integrate with existing data engineering infrastructure and support cross-functional analytical needs
* Create interactive dashboards and reports using business intelligence tools that translate complex data into actionable insights for stakeholders
* Perform advanced statistical analysis on patient longitudinal data and large customer datasets to identify trends, patterns, and strategic opportunities
* Develop and implement machine learning algorithms to enhance forecasting capabilities and predictive analytics across market access functions
* Collaborate closely with the data engineering team, SQL developers, and analytics product management to ensure data quality, pipeline efficiency, and business alignment
* Serve as the technical bridge between data engineering infrastructure and business-facing analytics, ensuring seamless integration of analytical solutions
* Partner cross-functionally with Pricing, Contract Development, Value and Access, Account Management, Finance, Forecasting, and Data Management teams to drive strategic initiatives
* Communicate complex analytical findings through compelling data narratives and visualizations tailored to diverse audiences
* Continuously evaluate and implement emerging methodologies and technologies in data science to advance the team's predictive capabilities
About You
Experience:
* 5+ years of experience in data science or advanced analytics within Pharmaceutical or Payer organizations
5+ years of hands-on experience building and deploying predictive models and machine learning solutions on large-scale datasets
* Demonstrated experience working with workflow orchestration tools (Dagster, Airflow, or similar) to productionize analytical models
* Proven track record of translating business problems into data science solutions that drive measurable outcomes
* Experience collaborating with data engineering teams and contributing to data pipeline development
Technical Skills:
* Advanced proficiency in Python or R for statistical modeling, machine learning, and data analysis
* Experience with ML frameworks (scikit-learn, TensorFlow, PyTorch, XGBoost, etc.) and predictive modeling techniques
* Hands-on experience with workflow orchestration platforms (Dagster, Airflow, Prefect, or similar)
* Proficiency in SQL for complex data manipulation and working with relational databases
* Expertise in data visualization tools (Tableau, Power BI, or similar) and creating executive-level dashboards
Experience with cloud platforms (Kubernetes) and modern data stack technologies
* Strong foundation in statistical methods, experimental design, and A/B testing
* Understanding of MLOps principles and model deployment best practices
Domain Knowledge:
* Deep understanding of pharmaceutical market access, pricing strategies, and reimbursement dynamics
* Experience analyzing longitudinal patient data, claims data, and formulary datasets
* Working knowledge of the US healthcare system, payer landscape, and regulatory environment
* Familiarity with healthcare data standards (e.g., NDC, HCPCS, ICD codes, IQVIA)
Soft Skills:
* Exceptional problem-solving abilities with a structured, hypothesis-driven approach
* Strong communication skills with ability to translate complex technical concepts for non-technical stakeholders
* Proven ability to manage multiple analytical projects simultaneously and meet deadlines
* Collaborative mindset with experience working across data engineering, product management, and business teams
* Detail-oriented with strong organizational and project management capabilities
* Self-directed learner who stays current with emerging data science methodologies and technologies
* Ability to mentor and provide technical guidance to developers and junior analysts
Education:
* BA or BS Degree
* Advanced Degree
Why Choose Us?
* Bring the miracles of science to life alongside a supportive, future-focused team.
* Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or a lateral move, at home or internationally.
* Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
* Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs, and at least 14 weeks' gender-neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
#GD-SG
#LI-GZ
#LI-Onsite
#vhd
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
North America Applicants Only
The salary range for this position is:
$148,500.00 - $214,500.00
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
$148.5k-214.5k yearly Auto-Apply 2d ago
Associate Director, Strategic Products and Portfolio Planning
Sanofi 4.3
Morristown, NJ jobs
Job Title: AssociateDirector, Strategic Products and Portfolio Planning
About the Job
Join the team protecting half a billion lives every year with next-gen science, mRNA innovation, and AI-driven breakthroughs. In Vaccines, you'll help advance prevention on a global scale - and shape the future of immunization.
Our organization in North America is growing fast, and we're always looking for talented professionals to join our Commercial Strategy and Marketing Operations & Excellence team.
Why Join Our Team?
Our Commercial Operations team aims for excellence. We offer a diverse and dynamic environment that's growing at pace. Over the next two years, we aim to grow our US business by $1 billion-and this role will be instrumental in achieving that ambition.
The AssociateDirector of Strategic Projects & Portfolio Planning will serve as a key strategic advisor within the Commercial Strategy and Marketing Operations & Excellence team, shaping long-term portfolio priorities and driving initiatives that position our business for sustainable growth. Reporting to the Head of Commercial Strategy and Marketing Operations & Excellence, this role combines strategic foresight with analytical rigor to influence senior leadership decisions and accelerate commercial excellence.
The ideal candidate thrives in fast-paced environments, seamlessly moving between high-level strategy and detailed analysis. You will navigate ambiguity, connect disparate information, and communicate effectively with senior stakeholders. This role offers significant visibility and growth potential for a high-performing professional looking to make a lasting impact.
About Sanofi:
We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.
Main Responsibilities
Analytics & Insights
Design and implement analytics on business performance and market dynamics to inform strategic decisions.
Synthesize data from multiple sources into actionable commercial and market insights.
Establish and maintain metrics, data sets, and KPIs to provide leadership with real-time visibility.
Collaborate across functions on analytics projects, including competitive intelligence and business performance tracking.
Strategic Thinking
Lead strategic assessments of market trends, competitive landscape, and portfolio performance to inform commercial strategy.
Partner with senior leadership to define portfolio priorities and evaluate new opportunities.
Develop market assessments and strategic presentations that provide comprehensive views of business performance and growth potential.
Senior Leadership Support
Act as a trusted advisor to senior leaders on strategic and analytic projects.
Prepare executive-level presentations for business reviews and leadership meetings.
Anticipate leadership needs and proactively deliver scenario analyses and insights that shape decision-making.
Cross-Functional Collaboration
Build strong relationships across sales, market access, marketing, and finance teams to ensure alignment on data and strategy.
Lead cross-functional working groups to address complex business challenges and drive consensus.
Project Management & Execution
Lead high-priority strategic initiatives from concept through implementation.
Manage complex projects with multiple workstreams and dependencies.
Develop clear project plans with milestones, deliverables, and accountability.
Bring structure and clarity to ambiguous business problems.
Communication & Influence
Create compelling, executive-level narratives that distill complex analyses into actionable recommendations.
Influence decision-makers through data storytelling and business case development.
Act as a thought leader, challenging assumptions and shaping strategic conversations at the highest levels.
About You
Qualifications
2-4 years of experience at a top-tier management consulting firm, with exposure to pharmaceutical/healthcare projects preferred.
Demonstrated expertise in data analysis, market assessment, strategic planning, and competitive intelligence.
Proven ability to translate complex market dynamics into actionable portfolio strategies.
Superior communication skills with the ability to influence senior leadership.
Exceptional project management capabilities with experience driving strategic initiatives.
Strong business acumen and commercial mindset.
Advanced proficiency in PowerPoint, Excel, and analytical tools.
Bachelor's degree required; MBA or other advanced degree preferred.
Language
Excellent English written and verbal communication skills.
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
#GD-SP
#LI-SP
#LI-Onsite
#vhd
Pursue
progress
, discover
extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
North America Applicants Only
The salary range for this position is:
$147,000.00 - $212,333.33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
$147k-212.3k yearly Auto-Apply 58d ago
Associate Director, Established Products Legacy Portfolio
Sanofi 4.3
Morristown, NJ jobs
Job Title: AssociateDirector, Established Products Legacy Portfolio
About the Job
Join the team transforming how healthcare is delivered for chronic and specialty conditions worldwide. In General Medicines, you'll help drive meaningful outcomes in diabetes, transplant, and immunology - with the scale and urgency patients deserve.
Sanofi's purpose of chasing the miracles of science to improve people's lives is aligned with 3 main objectives (I) keep fueling our pipeline (II) make Sanofi a modern science driven healthcare company (III)serving our patients.
As the AssociateDirector of Established Products Legacy Portfolio at Sanofi, you will support commercial efforts within a critical business unit responsible for managing a diverse portfolio of pharmaceutical products. Your strategic vision, market expertise, and leadership skills will drive the success of Synvisc and multiple Legacy Brands. The demand for effective pharmaceutical products remains high despite generic competition. This position requires a dynamic individual who can drive operational synergies, manage financial aspects and support various innovative initiatives. Your role as the AssociateDirector of US Established Products Legacy Portfolio will directly impact patient outcomes and contribute to our market success.
About Sanofi:
We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.
Main Responsibilities:
Portfolio Strategy:
Develop and execute tailored strategies for Synvisc and multiple Legacy Brands.
Monitor generic competition and market trends for each product.
Identify opportunities to differentiate our offerings and maintain competitive advantage.
Understand and evaluate the unique commercial dynamics for each franchise.
Work closely with Head of Essentials and Divestiture to identify opportunities to prune and divest products.
Financial Management:
Evaluate financial performance, pricing strategies, and resource allocation.
Optimize profitability while ensuring patient affordability.
Stakeholder Engagement:
Build strong relationships with healthcare professionals, payers, and distributors.
Collaborate with cross-functional teams to align strategies.
Risk Mitigation:
Assess risks related to generic competition, regulatory changes, and market shifts.
Develop risk mitigation plans to safeguard product performance.
About You
Qualifications:
Bachelor's degree in business, Life Sciences, or a related field (MBA preferred).
Minimum of 7 years related experience.
Proven experience in pharmaceutical leadership, specifically within product portfolio management.
Strong understanding of commercial operations, market access, and financial analysis.
Excellent communication, negotiation, and strategic thinking skills.
Critical Qualities:
Think Sanofi First:
Inspire trust through empathy and authenticity. Build and cultivate meaningful, powerful networks, within and outside Sanofi. Strong interpersonal, influencing, and motivating skills
Strategic Thinking:
Stay current with external trends to integrate insights into strategies and achieve sustainable competitive advantage. Well organized, highly motivated, process-driven, results-oriented personality
Share Sanofi's purpose, vision & strategy:
Take action to move Sanofi forwards, act for patients and customers, and demonstrate desire to bring the miracles of science to life to people
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
#GD-SG
#LI-GZ
#LI-Onsite
#vhd
Pursue
progress
, discover
extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
North America Applicants Only
The salary range for this position is:
$147,000.00 - $212,333.33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
$147k-212.3k yearly Auto-Apply 47d ago
Associate Director, Strategic Products and Portfolio Planning
Sanofi Group 4.3
Morristown, NJ jobs
**Job Title:** AssociateDirector, Strategic Products and Portfolio Planning **About the Job** Join the team protecting half a billion lives every year with next-gen science, mRNA innovation, and AI-driven breakthroughs. In Vaccines, you'll help advance prevention on a global scale - and shape the future of immunization.
Our organization in North America is growing fast, and we're always looking for talented professionals to join our **Commercial Strategy and Marketing Operations & Excellence** team.
**Why Join Our Team?**
Our Commercial Operations team aims for excellence. We offer a diverse and dynamic environment that's growing at pace. Over the next two years, we aim to grow our US business by **$1 billion** -and this role will be instrumental in achieving that ambition.
The **AssociateDirector of Strategic Projects & Portfolio Planning** will serve as a key strategic advisor within the **Commercial Strategy and Marketing Operations & Excellence** team, shaping long-term portfolio priorities and driving initiatives that position our business for sustainable growth. Reporting to the Head of Commercial Strategy and Marketing Operations & Excellence, this role combines strategic foresight with analytical rigor to influence senior leadership decisions and accelerate commercial excellence.
The ideal candidate thrives in fast-paced environments, seamlessly moving between high-level strategy and detailed analysis. You will navigate ambiguity, connect disparate information, and communicate effectively with senior stakeholders. This role offers significant visibility and growth potential for a high-performing professional looking to make a lasting impact.
**About Sanofi:**
We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.
**Main Responsibilities**
**Analytics & Insights**
+ Design and implement analytics on business performance and market dynamics to inform strategic decisions.
+ Synthesize data from multiple sources into actionable commercial and market insights.
+ Establish and maintain metrics, data sets, and KPIs to provide leadership with real-time visibility.
+ Collaborate across functions on analytics projects, including competitive intelligence and business performance tracking.
**Strategic Thinking**
+ Lead strategic assessments of market trends, competitive landscape, and portfolio performance to inform commercial strategy.
+ Partner with senior leadership to define portfolio priorities and evaluate new opportunities.
+ Develop market assessments and strategic presentations that provide comprehensive views of business performance and growth potential.
**Senior Leadership Support**
+ Act as a trusted advisor to senior leaders on strategic and analytic projects.
+ Prepare executive-level presentations for business reviews and leadership meetings.
+ Anticipate leadership needs and proactively deliver scenario analyses and insights that shape decision-making.
**Cross-Functional Collaboration**
+ Build strong relationships across sales, market access, marketing, and finance teams to ensure alignment on data and strategy.
+ Lead cross-functional working groups to address complex business challenges and drive consensus.
**Project Management & Execution**
+ Lead high-priority strategic initiatives from concept through implementation.
+ Manage complex projects with multiple workstreams and dependencies.
+ Develop clear project plans with milestones, deliverables, and accountability.
+ Bring structure and clarity to ambiguous business problems.
**Communication & Influence**
+ Create compelling, executive-level narratives that distill complex analyses into actionable recommendations.
+ Influence decision-makers through data storytelling and business case development.
+ Act as a thought leader, challenging assumptions and shaping strategic conversations at the highest levels.
**About You**
**Qualifications**
+ 2-4 years of experience at a top-tier management consulting firm, with exposure to pharmaceutical/healthcare projects preferred.
+ Demonstrated expertise in data analysis, market assessment, strategic planning, and competitive intelligence.
+ Proven ability to translate complex market dynamics into actionable portfolio strategies.
+ Superior communication skills with the ability to influence senior leadership.
+ Exceptional project management capabilities with experience driving strategic initiatives.
+ Strong business acumen and commercial mindset.
+ Advanced proficiency in PowerPoint, Excel, and analytical tools.
+ Bachelor's degree required; MBA or other advanced degree preferred.
**Language**
+ Excellent English written and verbal communication skills.
**Why Choose Us?**
+ Bring the miracles of science to life alongside a supportive, future-focused team.
+ Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
+ Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
+ Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
\#GD-SP
\#LI-SP
\#LI-Onsite
\#vhd
**Pursue** **_progress_** **, discover** **_extraordinary_**
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video (************************************************** and check out our Diversity Equity and Inclusion actions at sanofi.com (************************************************************************ !
_US and Puerto Rico Residents Only_
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
_North America Applicants Only_
The salary range for this position is:
$147,000.00 - $212,333.33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (********************************************************************************************************* .
Global Terms & Conditions and Data Privacy Statement (***************************************************************
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting ************** or via our movie We are Sanofi (*****************************
As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (************************************************
$147k-212.3k yearly 57d ago
Associate Director, US HEOR & RWE
Eisai 4.8
Nutley, NJ jobs
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
The AssociateDirector is responsible for supporting the development of strategies for assigned product(s) and execution of health economics, outcomes research and real-world evidence (HEOR & RWE) research to generate product value data to support Eisai business, including the development of communication tools. This role primarily focuses on late-stage pipeline and marketed products, interfaces with cross-functional teams including marketing, market access, and medical affairs to help develop HEOR strategy, and partners with HEOR field team in the development of external communication materials. The AssociateDirector facilitates coverage, reimbursement and appropriate utilization based on generation and communication of quality data.
Essential Functions
Support the formulation of HEOR and RWE strategies aligned with the business and patient needs to develop compelling value proposition that drives optimal access and utilization of Eisai marketed products in the United States.
Align health economics and outcomes research strategies, timelines and budgets with medical affairs, marketing, market access and global value and access teams. Projects will be prioritized to achieve effective utilization of resources; strategy will be aligned to the global business needs.
Partner with Field HEOR to develop the payer communication strategies, content and tools of product-specific health economic and outcomes value propositions. Support Eisai's recognition as a credible and forthright contributor to the assessment and optimal use of healthcare resources, and an advocate for patient access to appropriate therapeutic alternatives.
Execute all aspects of HEOR and RWE projects to meet the Eisai needs of key external stakeholders and internal business partners.
Effectively communicate and network to establish and maintain strong relationships with KOLs for HEOR and RWE related collaborations.
Monitor current methodological, clinical practice and professional guidelines, as they relate to health economics and outcomes, for the appropriate and optimal conduct of research and evaluations. Research project results have to be effective in ensuring that decision making will meet the needs of patients, providers and payers as well as optimize access to Eisai's products and appropriate medical care
Travel to national and international meetings and conferences to support the business needs.
Requirements
Doctoral degree (PhD, PharmD, MD) in health services research, public health, epidemiology, statistics, health economics, medicine, pharmacy administration or related field.
A minimum of 5 years' experience in RWE/Outcomes Research/Epidemiological Research/Health Economics either within biopharmaceutical industry and/or provider/payer organizations.
Demonstrated applied research experience in conducting health economic, health related quality of life, and/or health services research studies.
Experience in the design and execution of HEOR and RWE studies, including the writing of protocols and analytic plans for prospective and retrospective studies, analyzing and collecting patient-reported outcomes, claims and EMR databases.
Application of health economic models for product value assessment and comparison.
Strong scientific communication record in terms of the development of tools for field medical teams, conference presentations and manuscripts.
Demonstrated ability to work collaboratively in and lead cross-functional teams.
Development of professional relationships with customers, key opinion leaders and peers.
Strategic and conceptual skills to develop innovative approaches for demonstrating product value and differentiation
Preferred Knowledge
CNS therapeutic areas.
Knowledge of pharmaceutical development and lifecycle management.
Knowledge of regulatory and industry guidelines in the delivery of health care information in promotional and non-promotional settings and dissemination of health outcome studies and economic evaluations.
Background in statistics, epidemiology, and public health.
Pharmaceutical and reimbursement environment, especially as related to neuroscience.
Experience with utilization of outcomes studies in managed care or large healthcare organization environment.
Eisai Salary Transparency Language:
The annual base salary range for the AssociateDirector, US HEOR & RWE is from :$185,600-$243,600Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan.
Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.
Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit **********************************************************
Certain other benefits may be available for this position, please discuss any questions with your recruiter.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
Right To Work
E-Verify Participation
$185.6k-243.6k yearly Auto-Apply 9d ago
Associate Director, Regulatory Affairs CMC and Digital Transformation
Daiichi Sankyo 4.8
Ridgefield, NJ jobs
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Job Summary
The AssociateDirector, RACMC, is responsible for the regulatory CMC (Chemistry, Manufacturing and Controls) activities from early development to post-approval phase for biological, Cell and Gene Therapy, small molecule, Vaccines, and/or si RNA drug projects consistent with the company goals. Participate on G-RACMC teams and support or lead on Component teams and/or serve as G-RACMC lead or regional submission lead. Provide regulatory guidance and strategy to CMC sub-team and G-RA teams along with other functional teams leading to sound scientific development programs and successful registration for new compounds. Performs collaborative authoring with other RACMC regional team members and subject matter experts for Health Authority (HA) submission, HA meetings, and responses to HA queries. Support company goals to building filing strategies that lead to efficient submission timeline and approvals in assigned region.
Digital Transformation Responsibilities: The AssociateDirector, Digital Transformation (within Regulatory CMC), will serve as a strategic leader and change agent driving the organization's transition toward structured CMC data and next-generation digital capabilities. This role is critical to enabling the future of regulatory submissions, modernizing end-to-end CMC data management, and positioning the company for global competitiveness in an increasingly data-driven biopharmaceutical landscape. Experience with ICH M42(R2) and Ich M16 (SPQA) is preferred.
Responsibilities
* Organize and manage the preparation (content and format) of all types of submissions to Health Authorities.
* Coordinates activities required for timely and accurate reporting of information to existing submissions.
* Supervise the identification and compilation of required documentation for submission.
* Prioritizes workload. Evaluate content and adequacy of submissions and identify deficiencies against regulatory guidance's or internal data bases.
* Facilitate and support liaison activities with functional groups within Daiichi Sankyo, Inc. related to assigned products/project areas such as the clinical supplies organization, Reg Operations, Medical Affairs and labelling.
* Participates in meetings with Health Authorities.
* Prepares internal functional teams for these interactions to build strong relationships with FDA and secure successful meeting outcomes.
* Coordinates preparation, authors, and finalizes meeting materials to include meeting requests, briefing books and meeting minutes.
* Keep current with Regulatory guidelines and assists in educating the organization on evolving Regulatory Affairs CMC (RACMC) issues and regulations through internal technical seminars, global forums or trip reports.
* Participates on external industry consortiums (DS Consortium and Biophorum) to understand industry standards and contribute to policies and or standards. Identifies areas for process /procedure improvements and works on improvement implementation.
* Provides training on evolving regulations. This could involve Global RACMC teams or cross-functional initiatives within the company.
* Lead the transition to structured CMC data, including data standards, metadata models, and systems that support machine-readable regulatory submissions.
* Drive digital modernization by implementing tools for structured content authoring, automated data transfer, and data-driven dossier creation.
* Enable automation, AI, and analytics to reduce manual data handling, improve data integrity, and enhance decision-making across CMC functions.
* Partner cross-functionally with CMC, Quality, Manufacturing, Technical Operations, Regulatory, and IT to ensure alignment and readiness for structured data capabilities.
* Manage organizational change, including capability building, training, and communication to support adoption of new digital processes.
* Monitor global regulatory and industry trends and lead internal initiatives that position the company for future structured submission expectations and digital regulatory innovations.
Qualifications
Education Qualifications
* Bachelor's Degree Life Science Degree required Master's Degree preferred PharmD preferred
Experience Qualifications
* 7 or More Years in the pharmaceutical industry with significant experience in scientific/regulatory fields required
* Experience in Digital Transformation within Regulatory CMC required
* Experience in international Regulatory Affairs- CMC preferred
* Experience with ICH M42(R2) and Ich M16 (SPQA) is preferred.
Travel Requirements
* Ability to travel up to 10% of the time.
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Salary Range:
USD$159,440.00 - USD$239,160.00
Download Our Benefits Summary PDF
$159.4k-239.2k yearly 3d ago
Associate Director, Global Value & Access
Eisai 4.8
Nutley, NJ jobs
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
The Global AssociateDirector, will lead projects and contribute to the payer evidence strategy for key products in the Neurology or Oncology portfolio under the direction of the GV&A Executive Director and in collaboration with other GV&A and cross functional team members. This is an experienced and seasoned individual, who has worked at least 5 years in the pharmaceutical industry or consulting within the area of health outcomes and health economics and with a Global remit.
The role requires a strong technical background in evaluating clinical data and leading HEOR analyses such as systematic literature reviews, indirect treatment comparison, network meta analysis and various data syntheses including compiling and reviewing reports and presentations for internal and external payer use. A pre-requisite for this role is strong collaboration, communication and training skills to adeptly explain and disseminate strategy, projects and results. Experience and interest in building and maintaining internal stakeholder relationships is key.
It is expected that the AssociateDirector will work independently to complete analyses while proactively providing updates to the project team and according to timelines and requirements. The candidate should have a good working knowledge of the range of healthcare reimbursement systems and reimbursement guidelines.
This position is ideal for a candidate with a strong modeling and analytic background, desiring more exposure to reimbursement and value strategy development.
Essential Functions
Key deliverables development:
Global economic models and report
Country adaptations of economic models
Indirect treatment comparisons, network meta analyses
Post-hoc trial analyses
Global value dossiers
Literature reviews
Strategic business functions:
Collaborations with other departments (biostats, clinical, medical, commercial)
Strategic evidence gap assessment
Contribution to product evidence generation plan
Management of project vendors
Contract & budget tracking
Requirements
A postgraduate degree such as PhD, Pharm D, MPH in the area of Health Outcomes, or equivalent level of demonstrated experience is required.
5+ years' experience in health outcomes is required.
Previous Global HEOR / market access experience is required.
Previous experience in Alzheimer's / dementia is preferred
Competence in carrying out a variety of HEOR studies using a range of standard techniques
Ability to work cross-functionally within teams
Strong Excel modelling skills
Effective analytical/problem solving skills, including generation of original and innovative ideas and solutions
Action-oriented, customer-focused, with effective prioritization, goal-setting and time management skills
Experience in the design and programming of claims analysis and observational studies is desirable
Effective interpersonal skills; projection of professional image and credibility; teamwork oriented and inclusive
Record of peer-reviewed publication of original work in HEOR is desirable
Eisai Salary Transparency Language:
The annual base salary range for the AssociateDirector, Global Value & Access is from :$178,200-$233,900Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan.
Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.
Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit **********************************************************
Certain other benefits may be available for this position, please discuss any questions with your recruiter.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
Right To Work
E-Verify Participation
$178.2k-233.9k yearly Auto-Apply 37d ago
Associate Director, Value & Access, Neurology
Eisai 4.8
Nutley, NJ jobs
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
The AssociateDirector, Value & Access actively participates in planning and execution of Market Access strategy and manages assigned marketing initiatives for all channels (including strategy and tactics for new product launches and new indications; value propositions, key messaging, and pull-through initiatives for assigned portfolio of new and existing products; development and roll-out of communication plans). Additional responsibilities include but are not limited to the following:
Responsibilities:
Collaborate with cross-functional teams (e.g., brand, HEOR, market research, sales, regulatory, legal, field market access teams) to develop aligned market access strategies with measurable tactical programs.
Guide and participate in market research related to market access needs, including value proposition and market access landscape research.
Represent own projects in cross-functional meetings (e.g., CRC, PMRC, brand, market access meetings) to share market access views and strategies for brand, and provide advice to optimize cross-functional outcomes (e.g., medical, legal, alliance partners).
Provide oversight to external partner/vendor deliverables in line with defined objectives and scope for assigned products, and address critical escalations as warranted.
Provide inputs to overall development of market access brand plans and related scope/budget, monitor plans in line with budget, and address deviations.
Qualifications:
Bachelor's degree in sciences/business/finance or related field (MBA preferred); with 10+ years of relevant experience in pharma/biotech industry.
Experience across multiple channels (Medicare, Medicaid, Commercial, IDN's, GPO, SP, etc.) in supporting decision makers' efforts to launch pipeline of products and maximize current marketed brands.
Experience with leveraging brands patient's journey and translate into market access strategies, with measurable tactical programs; and managing marketing initiatives.
Experience working with core market access data tools, and developing and implementing data-driven strategies.
Experience launching novel products and managing established products in market access channels.
Experience establishing valid metrics; collecting information and identifying potential opportunities; prioritizing and implementing strategies.
Experience working in a collaborative decision-making environment and building advocacy for one's perspective through data analytics and networking.
Proven experience in earlier role.
Eisai Salary Transparency Language:
The annual base salary range for the AssociateDirector, Value & Access, Neurology is from :$178,200-$233,900Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan.
Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.
Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit **********************************************************
Certain other benefits may be available for this position, please discuss any questions with your recruiter.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
Right To Work
E-Verify Participation
**Job Title:** AssociateDirector, Cross-portfolio Analytics - Vaccines **About the Job** Ready to push the limits of what's possible? Join Sanofi in one of our corporate functions, and you can play a vital role in the performance of our entire business while helping to make a meaningful impact on millions around the world.
Currently, Sanofi has the most robust pipeline and forthcoming product launches in the company's history. As the next phase of our Play-To-Win strategy, Sanofi must effectively support this pipeline to bring our vision of delivering scientific miracles to patients worldwide to life. Thus, modernizing the Sanofi operational structure is also required. In line with this, project DRIVE is shepherding change throughout the organization and has created the development of the Go-to-Market Capabilities (GTMC) team within the company.
The new GTMC organization is charged with delivering best-in-class capabilities to bring speed and increased value to commercial operations. It will refine priorities across products, markets, and the pipeline through dynamic resource allocation and efficiencies. Silos that existed between business units, as well as duplicative and overlapping resources, will be replaced with standardized processes and tools. Operating with a One Sanofi mindset and entrepreneurial spirit, GTMC will accelerate and enhance key capabilities to do more with less, facilitating the best-informed strategic decision-making across the organization.
The GTMC organization aims to:
+ Centralize Go-to-Market operational tasks across GBUs
+ Standardize best-in-class capabilities, strengthen global support, and implement a better vertical reporting structure within GTMC from local to global
+ Define ways of working, bringing clarity on the interactions across GBUs, Digital, and Commercial executional support teams from Sanofi hubs to optimize process excellence and efficiency
The **AssociateDirector, Cross-portfolio Analytics - Vaccines,** will be responsible for the reporting and presenting Sanofi's portfolio performance and integrated insights to leadership. As a member of the Insights and Analytics (I&A) team, this individual will be an integral partner to the Sanofi brand teams, focusing on analyzing the performance of launched assets and preparing for future launches. This individual will be responsible for proactively identifying areas of opportunity by utilizing claims, SP, and CRM data.
This position will report to the Director Customer and GTM Strategy Analytics Vaccines and will be based in Morristown, NJ.
**About Sanofi:**
We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system, combined with our innovative pipeline, enables us to develop medicines and vaccines that treat and protect millions of people worldwide. Together, we chase the miracles of science to improve people's lives.
**Main Responsibilities:**
+ Act as a strategic partner to the brand team leadership in key activities, such as brand planning, performance reviews, new indication launches, and assessment of new initiatives
+ Partner with the brand team to develop and measure KPIs associated with brand strategy and tactics
+ Lead development and maintenance of KPI reports for the commercial team, covering Marketing, Sales, PSS, and Market Access functions
+ Synthesize brand performance metrics into a cohesive narrative, and deliver strategic insights to Commercial leadership
+ Support new launches through the leadership of behavioral segmentation and targeting
+ Perform ad-hoc national and sub-national analyses to proactively identify areas of opportunities and threats, leveraging marketing tactic utilization, sales execution, and customer adoption metrics
+ Partner with Analytics leads across Sanofi's portfolio to collaborate on Franchise performance insights and deep dives
+ Partner with Advanced Analytics colleagues to support optimization of promotional spend (e.g., marketing mix analyses) and better understand/impact key business levers (e.g., application of AI / ML models to understand patient conversion, predict HCP product selection, etc.)
+ Liaison with external vendors in the production of sub-national Sales Force Effectiveness reports
+ Create dashboards to synthesize information and enable business decisions
+ Coordinate with data management to ensure insights are based on reliable, high-quality information
+ Coach junior team members for onboarding, upskilling and Sanofi-specific processes/data
+ Lead the Hub team day-to-day on projects in a matrix management structure
**About You**
**BASIC QUALIFICATIONS:**
+ BA / BS with a minimum of 7 years of experience in pharmaceutical Brand / Advanced Analytics, Forecasting, and/or Sales Operations; equivalent combination of education (MS / MA / MBA / PhD) and/or consulting experience may be considered
+ Proven business acumen, with strong communication & presentation skills
+ Well-developed strategic thinking ability, with the capacity to synthesize disparate sources of data to provide a coherent narrative and actionable insights
+ Strong analytical skills, with the ability to design, develop, and execute analyses to answer complex business questions
+ Life sciences analytics experience, with understanding of best practices and ability to access and manipulate large data sets via cloud-based data warehouse/analytics platforms
+ Experience with programming languages (e.g., SQL, R, Python, etc.) and data science principles
+ Experience with key pharmaceutical data sources and analytics platforms, including:
o National-level sales/demand data (e.g., IQVIA NPA & NSP)
o Longitudinal HCP & patient-level claims (e.g., IQVIA, Symphony, Komodo, etc.)
o Specialty pharmacy/patient services data (e.g., Capgemini / LiquidHub)
o CRM systems (e.g., Veeva, Salesforce, etc.)
o Data management & analysis platforms (e.g., Databricks, Snowflake, etc.)
o Data visualization/business intelligence tools (e.g., Power BI, Tableau, Qlik, etc.)
o MS Office applications (Excel, PowerPoint, Word)
**PREFERRED QUALIFICATIONS:**
+ Master's Degree or MBA preferred
+ Experience in relevant Therapeutic Area
+ Ability to thrive in a fast-paced environment, comfortable with ambiguity, and with a track record of delivering exceptional results
+ Excellent project management and prioritization skills, able to deftly balance multiple projects/priorities
+ Ability to work in a matrixed environment with many cross-functional partners to understand and influence key business decisions
+ Experience in applying AI / Machine Learning/data science methodologies to address complex quantitative questions and derive action
**Why Choose Us?**
+ Bring the miracles of science to life alongside a supportive, future-focused team.
+ Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or a lateral move, at home or internationally.
+ Enjoy a thoughtful and well-crafted rewards package that recognizes your contributions and amplifies your impact.
+ Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs, and at least 14 weeks' gender-neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
\#GD-SG
\#LI-GZ
\#LI-Onsite
\#vhd
**Pursue** **_progress_** **, discover** **_extraordinary_**
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video (************************************************** and check out our Diversity Equity and Inclusion actions at sanofi.com (************************************************************************ !
_US and Puerto Rico Residents Only_
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
_North America Applicants Only_
The salary range for this position is:
$125,250.00 - $180,916.66
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (********************************************************************************************************* .
Global Terms & Conditions and Data Privacy Statement (***************************************************************
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting ************** or via our movie We are Sanofi (*****************************
As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (************************************************
Job Title: AssociateDirector, Cross-portfolio Analytics - Vaccines
About the Job
Ready to push the limits of what's possible? Join Sanofi in one of our corporate functions, and you can play a vital role in the performance of our entire business while helping to make a meaningful impact on millions around the world.
Currently, Sanofi has the most robust pipeline and forthcoming product launches in the company's history. As the next phase of our Play-To-Win strategy, Sanofi must effectively support this pipeline to bring our vision of delivering scientific miracles to patients worldwide to life. Thus, modernizing the Sanofi operational structure is also required. In line with this, project DRIVE is shepherding change throughout the organization and has created the development of the Go-to-Market Capabilities (GTMC) team within the company.
The new GTMC organization is charged with delivering best-in-class capabilities to bring speed and increased value to commercial operations. It will refine priorities across products, markets, and the pipeline through dynamic resource allocation and efficiencies. Silos that existed between business units, as well as duplicative and overlapping resources, will be replaced with standardized processes and tools. Operating with a One Sanofi mindset and entrepreneurial spirit, GTMC will accelerate and enhance key capabilities to do more with less, facilitating the best-informed strategic decision-making across the organization.
The GTMC organization aims to:
Centralize Go-to-Market operational tasks across GBUs
Standardize best-in-class capabilities, strengthen global support, and implement a better vertical reporting structure within GTMC from local to global
Define ways of working, bringing clarity on the interactions across GBUs, Digital, and Commercial executional support teams from Sanofi hubs to optimize process excellence and efficiency
The AssociateDirector, Cross-portfolio Analytics - Vaccines, will be responsible for the reporting and presenting Sanofi's portfolio performance and integrated insights to leadership. As a member of the Insights and Analytics (I&A) team, this individual will be an integral partner to the Sanofi brand teams, focusing on analyzing the performance of launched assets and preparing for future launches. This individual will be responsible for proactively identifying areas of opportunity by utilizing claims, SP, and CRM data.
This position will report to the Director Customer and GTM Strategy Analytics Vaccines and will be based in Morristown, NJ.
About Sanofi:
We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system, combined with our innovative pipeline, enables us to develop medicines and vaccines that treat and protect millions of people worldwide. Together, we chase the miracles of science to improve people's lives.
Main Responsibilities:
Act as a strategic partner to the brand team leadership in key activities, such as brand planning, performance reviews, new indication launches, and assessment of new initiatives
Partner with the brand team to develop and measure KPIs associated with brand strategy and tactics
Lead development and maintenance of KPI reports for the commercial team, covering Marketing, Sales, PSS, and Market Access functions
Synthesize brand performance metrics into a cohesive narrative, and deliver strategic insights to Commercial leadership
Support new launches through the leadership of behavioral segmentation and targeting
Perform ad-hoc national and sub-national analyses to proactively identify areas of opportunities and threats, leveraging marketing tactic utilization, sales execution, and customer adoption metrics
Partner with Analytics leads across Sanofi's portfolio to collaborate on Franchise performance insights and deep dives
Partner with Advanced Analytics colleagues to support optimization of promotional spend (e.g., marketing mix analyses) and better understand/impact key business levers (e.g., application of AI / ML models to understand patient conversion, predict HCP product selection, etc.)
Liaison with external vendors in the production of sub-national Sales Force Effectiveness reports
Create dashboards to synthesize information and enable business decisions
Coordinate with data management to ensure insights are based on reliable, high-quality information
Coach junior team members for onboarding, upskilling and Sanofi-specific processes/data
Lead the Hub team day-to-day on projects in a matrix management structure
About You
BASIC QUALIFICATIONS:
BA / BS with a minimum of 7 years of experience in pharmaceutical Brand / Advanced Analytics, Forecasting, and/or Sales Operations; equivalent combination of education (MS / MA / MBA / PhD) and/or consulting experience may be considered
Proven business acumen, with strong communication & presentation skills
Well-developed strategic thinking ability, with the capacity to synthesize disparate sources of data to provide a coherent narrative and actionable insights
Strong analytical skills, with the ability to design, develop, and execute analyses to answer complex business questions
Life sciences analytics experience, with understanding of best practices and ability to access and manipulate large data sets via cloud-based data warehouse/analytics platforms
Experience with programming languages (e.g., SQL, R, Python, etc.) and data science principles
Experience with key pharmaceutical data sources and analytics platforms, including:
o National-level sales/demand data (e.g., IQVIA NPA & NSP)
o Longitudinal HCP & patient-level claims (e.g., IQVIA, Symphony, Komodo, etc.)
o Specialty pharmacy/patient services data (e.g., Capgemini / LiquidHub)
o CRM systems (e.g., Veeva, Salesforce, etc.)
o Data management & analysis platforms (e.g., Databricks, Snowflake, etc.)
o Data visualization/business intelligence tools (e.g., Power BI, Tableau, Qlik, etc.)
o MS Office applications (Excel, PowerPoint, Word)
PREFERRED QUALIFICATIONS:
Master's Degree or MBA preferred
Experience in relevant Therapeutic Area
Ability to thrive in a fast-paced environment, comfortable with ambiguity, and with a track record of delivering exceptional results
Excellent project management and prioritization skills, able to deftly balance multiple projects/priorities
Ability to work in a matrixed environment with many cross-functional partners to understand and influence key business decisions
Experience in applying AI / Machine Learning/data science methodologies to address complex quantitative questions and derive action
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or a lateral move, at home or internationally.
Enjoy a thoughtful and well-crafted rewards package that recognizes your contributions and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs, and at least 14 weeks' gender-neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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Pursue
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, discover
extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
North America Applicants Only
The salary range for this position is:
$125,250.00 - $180,916.66
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Job Summary
Position will be a member of the Risk Management Center of Excellence office who will help manage risk management initiatives and activities defined by leadership. Individual will provide strategic advice, teachings, and support related to risk management planning, risk management sciences, and risk management tools and resources.
Job Description
Responsibilities
Strategic Advice and Support to Global Product Teams:
* Provides expert, strategic advice on the creation and submission of RMPs and REMS.
* Own and maintain the process for creating RMPs.
* Provides expert, strategic advice on executing the requirements of RMP/REMS (including acquiring appropriate tools and competent vendors).
* Guides and supports teams on tracking submissions (and following the status of submissions).
* Guides in creating assessment reports.
* Guides and supports with the alignment of RMPs, labels in key regions (US, EU, Japan) and periodic reports.
Risk Management Champion:
* Serves as member of the Risk Management office to provide knowledge of regulator and industry trends related to risk management.
* May draft and/or propose changes to SOPs/SOIs related to risk management.
* Keeps management aware of any gaps in risk management planning, creation, and execution Lead/Manage RMP initiatives.
* Lead and/manage RMP initiatives and activities related to risk management planning, risk management sciences, and risk management tools and resources.
* Risk Management Compliance & Inspection Readiness Champion.
* Serve as member of Risk Management office to ensure risk management activities allow for effective preparation for inspections/audits.
* Serve a key support during Risk Management Inspections.
Qualifications
Education Qualifications
* Bachelor's degree in healthcare related field required
* PharmD or PhD preferred
Experience Qualifications
* 4 or more years of relevant experience in risk management and project management required
Travel Requirements
* Ability to travel up to 20% of the time. Domestic and International travel.
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Salary Range:
USD$150,800.00 - USD$226,200.00
Download Our Benefits Summary PDF
$150.8k-226.2k yearly 3d ago
Associate Director, Global Submission Management
Eisai 4.8
Nutley, NJ jobs
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
The AssociateDirector of Global Submission Management (GSM) is responsible for leading, managing, strategizing, and overseeing the planning, preparation, coordination, and delivery of global regulatory submissions in compliance with applicable regulations and standards. This role involves providing hands-on operational support for submission activities while ensuring strategic alignment and process optimization across different regions. It also includes resource planning, budgeting, vendor management, and technical oversight to support the objectives of Global Regulatory Operations. The AssociateDirector will collaborate with the Heads of Submissions Management for the EU and Japan as needed and utilize “Follow-the-sun” processes to ensure submission timelines are met regardless of the region.
The AssociateDirector, Global Submission Management (GSM, is responsible for the effective operation of Global Submission projects, ensuring the consistent application of global procedures and standards, and proactively assessing process performance for necessary optimizations. The AssociateDirector serves as the primary liaison between R&D functions, acting as the submission lead for designated global applications (e.g., INDs, NDAs, MAAs, supplements, amendments, and variations), to facilitate cross-functional logistics and communication that support submission planning. This role provides submission leadership by managing the operational aspects of global regulatory submissions to produce high-quality, time-sensitive deliverables in accordance with agreed-upon submission timelines. Additionally, the AD oversees the process for creating and updating the Global Regulatory Operations Submission Content Plan (GSCP) for major regulatory submission final deliverables, ensuring compliance with applicable regulatory agency regulations, guidelines, and specifications (e.g., FDA, EMA, HC, PMDA, Emerging Markets, ICH, CDISC) within defined timelines.
Essential Functions:
Leadership and Strategy
Provides leadership for the Global Submissions Team ensuring projects are appropriately resourced, partnering with other regional Submission Heads for additional support for resources when needed.
Provides the Regulatory Submission Management for a lead compound or submission project that has been identified as critical to Eisai's business success.
Provides management oversight for the Global Submission Management department, supporting the generation, and when necessary, the re-engineering of Eisai “Best Practices” related to global submission management and dossier development in pursuit of optimal processing performance while maintaining full compliance with Health Authority requirements and guideline.
Global Collaboration
Collaborates with the EU and Japan Heads of Submission Management to optimize resource allocation and implement “follow-the-sun” workflows for timely submissions across all regions.
Foster strong cross-regional communication and collaboration to support global objectives.
Promotes a culture of performance and teamwork, with a focus on staff development in technical skills, interpersonal skills, education, and training, enhancing competency and professionalism.
Maintains visibility within the organization by regularly presenting on various GSM-related topics. This includes showcasing the achievements, ongoing projects, and developments of the GSM organization, as well as emerging trends in eCTD regulatory submissions. Additionally, cultivate positive and constructive relationships with other members of the Global Regulatory Operations (GRO) team and regulatory colleagues.
Actively participates in agency/industry events regularly, staying abreast of current developments, trends, and technologies, fostering constructive business relations with other industry peers, Health Authority representatives, and critical business partners/vendors.
Analyzes trends and evaluates the impact of changes in Health Authority requirements for e-submissions, communicating these changes to the relevant areas within Eisai and driving the necessary changes to processes and procedures.
Ensure the timely completion of all administrative tasks for this position, including but not limited to monthly reports, performance objective setting, performance reviews, and training, for self and staff.
Hands-On Submission Support
Actively participates in submission planning and execution, including document compilation, publishing, and quality checks.
Provide technical oversight and troubleshooting for eCTD submissions and related systems.
Operational Excellence
Ensure consistent application of GSM global procedures and standards.
Proactively monitors and assess process performance, identifying opportunities for continuous improvement.
Requirements
Bachelor's degree in scientific or information technology field; advanced degree preferred
8+ years of pharmaceutical industry regulatory experience
5+ years of experience with submissions management, process development, standards development and compilation of electronic major submissions required
Proficient with U.S. and EU submission requirements including but not limited to Emerging Markets
Advance experience with the drug development process and eCTD regulatory submission standards
Expert understanding of Project Management concepts and techniques
Ability to apply SOPs regulations pertaining to electronic submissions
Ability to lead cross-functional team, establish effective relationships with team members and work well in a cross functional team environment
Advance experience creating timelines for the development and submission of drug filings to regulatory health authorities
Excellent organizational skills to support multi-task and manage submission timelines in a fast-paced environment with changing priorities
Well-organized with the ability to multi-task and work with minimal supervision
Ability to manage change to support organization's effectiveness by implementing change
Effectively communicates written and verbal communication skills
Demonstrates strong analytical, problem solving and critical thinking skills with the ability to analyze problems, identify alternative solutions and implement recommendations for resolution.
Certification is a plus (such as Regulatory Affairs Professional Society (RAPS)
Technical Skills Required
Advance working knowledge of global regulatory submission standards, publishing software, software validation concepts, and regulatory publishing best practices
Proficiency in eCTD publishing tools (e.g., Lorenz docu Bridge, Extedo eCTDmanager, or equivalent).
Strong understanding of ICH guidelines, regional regulatory requirements, and data standards (e.g., CDISC).
Extensive experience with Regulatory Information Management (RIM) systems and Document Management Systems (e.g., Veeva Vault, SharePoint, Documentum)
PowerPoint, SharePoint, XML, Adobe Acrobat, ISI Toolbox and eData transfer systems
Ability to troubleshoot technical issues related to electronic submissions and publishing.
We are open to remote-based, but the preference for this role is a hybrid work arrangement in Nutley, NJ with 3 days a week in office every week (Tuesday, Wednesday. Thursday).
Eisai Salary Transparency Language:
The annual base salary range for the AssociateDirector, Global Submission Management is from :$159,000-$208,700Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan.
Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.
Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit **********************************************************
Certain other benefits may be available for this position, please discuss any questions with your recruiter.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
Right To Work
E-Verify Participation
$159k-208.7k yearly Auto-Apply 47d ago
Associate Director, Global Submission Management
Eisai Us 4.8
Nutley, NJ jobs
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
The AssociateDirector of Global Submission Management (GSM) is responsible for leading, managing, strategizing, and overseeing the planning, preparation, coordination, and delivery of global regulatory submissions in compliance with applicable regulations and standards. This role involves providing hands-on operational support for submission activities while ensuring strategic alignment and process optimization across different regions. It also includes resource planning, budgeting, vendor management, and technical oversight to support the objectives of Global Regulatory Operations. The AssociateDirector will collaborate with the Heads of Submissions Management for the EU and Japan as needed and utilize "Follow-the-sun" processes to ensure submission timelines are met regardless of the region.
The AssociateDirector, Global Submission Management (GSM, is responsible for the effective operation of Global Submission projects, ensuring the consistent application of global procedures and standards, and proactively assessing process performance for necessary optimizations. The AssociateDirector serves as the primary liaison between R&D functions, acting as the submission lead for designated global applications (e.g., INDs, NDAs, MAAs, supplements, amendments, and variations), to facilitate cross-functional logistics and communication that support submission planning. This role provides submission leadership by managing the operational aspects of global regulatory submissions to produce high-quality, time-sensitive deliverables in accordance with agreed-upon submission timelines. Additionally, the AD oversees the process for creating and updating the Global Regulatory Operations Submission Content Plan (GSCP) for major regulatory submission final deliverables, ensuring compliance with applicable regulatory agency regulations, guidelines, and specifications (e.g., FDA, EMA, HC, PMDA, Emerging Markets, ICH, CDISC) within defined timelines.
Essential Functions:
Leadership and Strategy
* Provides leadership for the Global Submissions Team ensuring projects are appropriately resourced, partnering with other regional Submission Heads for additional support for resources when needed.
* Provides the Regulatory Submission Management for a lead compound or submission project that has been identified as critical to Eisai's business success.
* Provides management oversight for the Global Submission Management department, supporting the generation, and when necessary, the re-engineering of Eisai "Best Practices" related to global submission management and dossier development in pursuit of optimal processing performance while maintaining full compliance with Health Authority requirements and guideline.
Global Collaboration
* Collaborates with the EU and Japan Heads of Submission Management to optimize resource allocation and implement "follow-the-sun" workflows for timely submissions across all regions.
* Foster strong cross-regional communication and collaboration to support global objectives.
* Promotes a culture of performance and teamwork, with a focus on staff development in technical skills, interpersonal skills, education, and training, enhancing competency and professionalism.
* Maintains visibility within the organization by regularly presenting on various GSM-related topics. This includes showcasing the achievements, ongoing projects, and developments of the GSM organization, as well as emerging trends in eCTD regulatory submissions. Additionally, cultivate positive and constructive relationships with other members of the Global Regulatory Operations (GRO) team and regulatory colleagues.
* Actively participates in agency/industry events regularly, staying abreast of current developments, trends, and technologies, fostering constructive business relations with other industry peers, Health Authority representatives, and critical business partners/vendors.
* Analyzes trends and evaluates the impact of changes in Health Authority requirements for e-submissions, communicating these changes to the relevant areas within Eisai and driving the necessary changes to processes and procedures.
* Ensure the timely completion of all administrative tasks for this position, including but not limited to monthly reports, performance objective setting, performance reviews, and training, for self and staff.
Hands-On Submission Support
* Actively participates in submission planning and execution, including document compilation, publishing, and quality checks.
* Provide technical oversight and troubleshooting for eCTD submissions and related systems.
Operational Excellence
* Ensure consistent application of GSM global procedures and standards.
* Proactively monitors and assess process performance, identifying opportunities for continuous improvement.
Requirements
* Bachelor's degree in scientific or information technology field; advanced degree preferred
* 8+ years of pharmaceutical industry regulatory experience
* 5+ years of experience with submissions management, process development, standards development and compilation of electronic major submissions required
* Proficient with U.S. and EU submission requirements including but not limited to Emerging Markets
* Advance experience with the drug development process and eCTD regulatory submission standards
* Expert understanding of Project Management concepts and techniques
* Ability to apply SOPs regulations pertaining to electronic submissions
* Ability to lead cross-functional team, establish effective relationships with team members and work well in a cross functional team environment
* Advance experience creating timelines for the development and submission of drug filings to regulatory health authorities
* Excellent organizational skills to support multi-task and manage submission timelines in a fast-paced environment with changing priorities
* Well-organized with the ability to multi-task and work with minimal supervision
* Ability to manage change to support organization's effectiveness by implementing change
* Effectively communicates written and verbal communication skills
* Demonstrates strong analytical, problem solving and critical thinking skills with the ability to analyze problems, identify alternative solutions and implement recommendations for resolution.
* Certification is a plus (such as Regulatory Affairs Professional Society (RAPS)
Technical Skills Required
* Advance working knowledge of global regulatory submission standards, publishing software, software validation concepts, and regulatory publishing best practices
* Proficiency in eCTD publishing tools (e.g., Lorenz docu Bridge, Extedo eCTDmanager, or equivalent).
* Strong understanding of ICH guidelines, regional regulatory requirements, and data standards (e.g., CDISC).
* Extensive experience with Regulatory Information Management (RIM) systems and Document Management Systems (e.g., Veeva Vault, SharePoint, Documentum)
* PowerPoint, SharePoint, XML, Adobe Acrobat, ISI Toolbox and eData transfer systems
* Ability to troubleshoot technical issues related to electronic submissions and publishing.
We are open to remote-based, but the preference for this role is a hybrid work arrangement in Nutley, NJ with 3 days a week in office every week (Tuesday, Wednesday. Thursday).
Eisai Salary Transparency Language:
The annual base salary range for the AssociateDirector, Global Submission Management is from :$159,000-$208,700
Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan.
Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.
Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit **********************************************************
Certain other benefits may be available for this position, please discuss any questions with your recruiter.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
Right To Work
E-Verify Participation