Global Switch Medical Strategy Lead
- Location: Morristown, NJ /Hybrid
About the job
Are you ready to shape the future of Consumer Health? Your skills could be critical in helping our teams accelerate progress. Join our Safety team as a Global Switch Medical Strategy Lead where you will responsible for managing the portfolio of switch products. Provides support to the Global Switch Team and cross-functional teams on medical aspects including assessing new switch assets.
This role involves developing and executing medical strategies for multiple global programs for both development and lifecycle, interacting with cross-functional teams, and collaborating with internal and key external stakeholders. The individual will also be responsible for defining and executing the medical roadmap in alignment with the switch strategy. Works together with the Switch Science Lead and project team(s) in helping drive the medical strategy. The individual will manage few medical experts working on programs as direct reports.
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The ideal candidate is an experienced leader, who has a deep medical knowledge, experienced in clinical research including phase 3/4 clinical trials with demonstrated ability to work in a matrix environment and implement operational medical excellence. The individual must have a strong understanding of technical requirements for switch. Proven experience in clinical and consumer behavior studies for switches is strongly desired. Knowledge and experience outside the US are desired.
Opella, the Consumer Healthcare business unit of Sanofi, is the purest and third-largest player globally in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market.
We have an unshakable belief in the power of self-care and the role it can play in creating a healthier society and a healthier planet.
That's why we want to make self-care as simple as it should be by being consumer-led always, with science at our core.
Through our unique and balanced portfolio of more than 100 loved brands, including 15 global and local high-growth challengers such as Allegra, Dulcolax and Buscopan, we deliver our mission: helping more than half a billion consumers worldwide take their health in their hands.
This mission is brought to life by an 11,000-strong team, 13 best-in-class manufacturing sites, and 4 specialized science and innovation development centers.
We are also proud to be the first major fast-moving consumer healthcare company to achieve B Corp certification.
Join us on our mission. Health. In your hands.
Main responsibilities:
- Lead Medical Strategy Development - Drive the creation of global medical strategies for Rx-to-OTC switch programs, collaborating with science, regulatory, and commercial teams to ensure alignment.
- External Expert Engagement - Manage collaboration with external experts by leading advisory board meetings and advisory committee activities to gather insights and support switch strategies.
- Medical Leadership in Clinical Programs - Serve as the medical lead for switch programs and clinical studies (e.g., Actual Use Trials), ensuring compliance with clinical, regulatory, and safety requirements.
- Health Authority Engagement - Provide medical leadership in Health Authority meetings, contributing to and reviewing briefing packages to ensure successful regulatory interactions.
- Dossier and Risk Management - Contribute to global registration dossier development (DSUR/PSUR, PBRER, RMP) and lead risk mitigation strategies to achieve timely regulatory approvals.
- Switch Program Evidence & Publications - Develop innovative evidence-generation strategies and robust publication plans to support benefit-risk assessments and the success of switch programs.
- Cross-Functional Collaboration - Collaborate with internal stakeholders (R&D, regulatory, safety, medical affairs, commercial) to drive switch-related clinical trials, assess market opportunities, and contribute to innovation pipeline strategies.
About you
- Education/Training - A technical associate's degree or equivalent documented training in
- Advanced Degree - An advanced degree such as MS, PhD, or PharmD is required; an MD is preferred for this position.
- Extensive Experience - 15+ years of relevant experience, with at least 5 years in Medical Affairs, including exposure to switch programs and consumer behavioral studies.
- Switch Product Expertise - Significant experience in the development of switch products, including clinical development, consumer studies, and regulatory processes for switch programs.
- Global/Regional Experience - Experience in global or regional roles with a strong understanding of regulatory landscapes and cross-market switch assessments.
- Specialized Knowledge - Expertise in clinical and consumer studies relevant to switch products, drug-device combination products, and advisory committee or board meetings.
- Leadership and Collaboration - Proven track record of managing direct reports, working cross-functionally, and leading cross-departmental projects with a strategic and consumer-focused mindset.
- Communication and Adaptability - Strong written and verbal communication skills, with the ability to adapt to a changing regulatory environment and drive medical strategies aligned with business needs.
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.