Global Clinical Development Strategy Lead, Vaccine

Sanofi

Waltham (MA)

On-site

USD 180,000 - 240,000

Full time

6 days ago

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Benefits offered by this job

Health insurance

Job summary

Sanofi seeks a Global Clinical Development Strategy Expert to drive clinical development strategy and execution for acne vaccine and related targets. You will lead a Clinical Team and collaborate across monitoring, data management, biostatistics, medical writing, pharmacovigilance, and regulatory affairs to ensure rigorous, compliant development.

You will shape the development plan, manage licensure evidence, and interact with authorities while upholding Sanofi SOPs and fostering external

Qualifications

MD or PhD with extensive clinical development experience.
Experience leading cross-functional clinical teams.
Proven track record in vaccine or therapeutics development.

Responsibilities

Define the strategic clinical development plan aligned with global R&D strategy and regulatory needs.
Lead the Clinical Team and support monitoring, data management, statistics, medical writing, pharmacovigilance and regulatory affairs.
Manage the clinical development process from early-stage to licensure and evidence generation.
Collaborate with pharmacovigilance to define safety surveillance and risk management plans.
Prepare key clinical documents (protocols, reports) and CTD submissions for authorities.
Ensure SOPs align with Sanofi standards and continuously improve processes.
Build a network of internal and external collaborators and authorities.