Global Clinical Development Strategy Expert

Key Responsibilities:
- Define and present the strategic clinical development plan aligned with global R&D strategy, franchise strategy, and regulatory needs.
- Lead the Clinical Team and support monitoring, data management, biostatistics, medical writing, pharmacovigilance, and regulatory affairs.
- Manage clinical development from early-stage through licensure, providing clinical leadership for evidence generation to support licensure and commercialization.
- Partner with pharmacovigilance to define safety surveillance processes and design the safety risk management plan.
- Lead preparation of key trial/registration documents (protocols, reports, CTD submissions) and interactions with governance bodies, external experts, and competent authorities.
- Ensure development processes align with Sanofi SOPs and help review/improve SOPs.
- Build and maintain networks of internal/external collaborators, opinion leaders, investigators, and competent authorities.

Qualifications:
- MD specializing in Dermatology, Infectious Diseases, Pediatrics, Internal Medicine (or related) OR PhD (Biology, Immunology, Pharmacology, or related) with extensive clinical development experience.
- 5–10+ years in clinical development with demonstrated vaccine/therapeutics strategy experience.
- Experience working according to GCP/ICH guidelines.
- Proven ability to lead and manage transversal teams.
- Regulatory submissions and health authority interaction experience.

Preferred Skills/Experience:
- Clinical immunology background.
- Expertise in Dermatology, Infectious Diseases, Pediatrics, or Internal Medicine.
- Experience with therapeutic vaccines, especially for acne (and later-stage development).
- Excellent English oral/written communication.
- Autonomy, change leadership, and ability to work with diverse stakeholders.

Benefits (if explicitly stated):
- Rewards package; high-quality healthcare; prevention and wellness programs; at least 14 weeks’ gender-neutral parental leave.