Full-Time

Global Switch Medical Strategy Lead

Confirmed live in the last 24 hours

Sanofi

Sanofi

10,001+ employees

Global healthcare provider of pharmaceuticals and vaccines

Biotechnology
Healthcare

Senior, Expert

Morristown, NJ, USA

Hybrid position requiring in-office presence.

Category
Physicians & Surgeons
Medical, Clinical & Veterinary
Requirements
  • A technical associate's degree or equivalent documented training
  • An advanced degree such as MS, PhD, or PharmD is required; an MD is preferred
  • 15+ years of relevant experience, with at least 5 years in Medical Affairs, including exposure to switch programs and consumer behavioral studies
  • Significant experience in the development of switch products, including clinical development, consumer studies, and regulatory processes for switch programs
  • Experience in global or regional roles with a strong understanding of regulatory landscapes and cross-market switch assessments
  • Expertise in clinical and consumer studies relevant to switch products, drug-device combination products, and advisory committee or board meetings
  • Proven track record of managing direct reports, working cross-functionally, and leading cross-departmental projects with a strategic and consumer-focused mindset
  • Strong written and verbal communication skills, with the ability to adapt to a changing regulatory environment and drive medical strategies aligned with business needs
Responsibilities
  • Drive the creation of global medical strategies for Rx-to-OTC switch programs, collaborating with science, regulatory, and commercial teams to ensure alignment
  • Manage collaboration with external experts by leading advisory board meetings and advisory committee activities to gather insights and support switch strategies
  • Serve as the medical lead for switch programs and clinical studies (e.g., Actual Use Trials), ensuring compliance with clinical, regulatory, and safety requirements
  • Provide medical leadership in Health Authority meetings, contributing to and reviewing briefing packages to ensure successful regulatory interactions
  • Contribute to global registration dossier development (DSUR/PSUR, PBRER, RMP) and lead risk mitigation strategies to achieve timely regulatory approvals
  • Develop innovative evidence-generation strategies and robust publication plans to support benefit-risk assessments and the success of switch programs
  • 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
Desired Qualifications
  • Proven experience in clinical and consumer behavior studies for switches is strongly desired
  • Knowledge and experience outside the US are desired

Sanofi provides healthcare solutions through the development of treatments and vaccines. The company focuses on research and development to create new medicines and improve existing ones, particularly in areas like immunology, oncology, and rare diseases. Sanofi's products include prescription medications, over-the-counter items, and vaccines, which are distributed to patients, healthcare professionals, and governments. What sets Sanofi apart from its competitors is its strong emphasis on scientific innovation and extensive R&D efforts, supported by strategic partnerships and a diverse product pipeline. The goal of Sanofi is to enhance health outcomes and improve the quality of life for people globally by delivering effective and safe healthcare solutions.

Company Stage

IPO

Total Funding

$2B

Headquarters

Paris, France

Founded

1973

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Simplify's Take

What believers are saying

  • Tolebrutinib's FDA Breakthrough Therapy designation boosts Sanofi's neurology portfolio.
  • Dupixent's EU approval for young children expands Sanofi's pediatric market.
  • Sanofi's partnership with BrightInsight accelerates digital health solution development.

What critics are saying

  • Liver enzyme elevations in tolebrutinib patients may affect market acceptance.
  • Increased competition in rare diseases from biotech startups challenges Sanofi.
  • Regulatory delays could impact Dupixent's approval for chronic spontaneous urticaria.

What makes Sanofi unique

  • Sanofi's Care4Rare program supports innovative solutions for rare diseases.
  • The MyWay app enhances patient engagement and medication adherence.
  • Sanofi's Muse AI tool optimizes patient recruitment in clinical trials.

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Benefits

Health Insurance

Professional Development Budget

Parental Leave