Global Clinical Development Strategy Expert
Sanofi
August 26, 2026
Remote friendly (Waltham, MA)
United States
$178,500 - $257,833.33 USD yearly
Clinical Research and Development
Key Responsibilities:
- Define and present the strategic clinical development plan aligned with global R&D, franchise, 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 supporting licensure and commercialization.
- Partner with pharmacovigilance to define safety surveillance processes and design the safety risk management plan.
- Lead preparation of key clinical documents (protocols, reports), CTD submissions, and interactions with governance bodies, external experts, and competent authorities.
- Ensure operational processes align with Sanofi SOPs and help review/improve SOPs.
- Build and maintain a network of internal/external collaborators, opinion leaders, investigators, and competent authorities.
Qualifications:
- MD specializing in Dermatology, Infectious Diseases, Pediatrics, Internal Medicine, or related field; or PhD (Biology, Immunology, Pharmacology, or related) with extensive clinical development experience.
- 5–10+ years clinical development experience with vaccine/therapeutics development and clinical strategy (academia, non-profit, government, or industry).
- Experience working per GCP/ICH guidelines.
- Experience with regulatory submissions and interactions with health authorities.
Skills/Preferences:
- Background in clinical immunology (welcome); Dermatology/Infectious Diseases/Pediatrics/Internal Medicine expertise preferred.
- Experience with therapeutic vaccines, particularly acne (highly valued).
- Excellent English communication; autonomy, leadership, and ability to work with diverse stakeholders.
Benefits (explicitly stated):
- At least 14 weeks’ gender-neutral parental leave; health and wellbeing benefits.
- Define and present the strategic clinical development plan aligned with global R&D, franchise, 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 supporting licensure and commercialization.
- Partner with pharmacovigilance to define safety surveillance processes and design the safety risk management plan.
- Lead preparation of key clinical documents (protocols, reports), CTD submissions, and interactions with governance bodies, external experts, and competent authorities.
- Ensure operational processes align with Sanofi SOPs and help review/improve SOPs.
- Build and maintain a network of internal/external collaborators, opinion leaders, investigators, and competent authorities.
Qualifications:
- MD specializing in Dermatology, Infectious Diseases, Pediatrics, Internal Medicine, or related field; or PhD (Biology, Immunology, Pharmacology, or related) with extensive clinical development experience.
- 5–10+ years clinical development experience with vaccine/therapeutics development and clinical strategy (academia, non-profit, government, or industry).
- Experience working per GCP/ICH guidelines.
- Experience with regulatory submissions and interactions with health authorities.
Skills/Preferences:
- Background in clinical immunology (welcome); Dermatology/Infectious Diseases/Pediatrics/Internal Medicine expertise preferred.
- Experience with therapeutic vaccines, particularly acne (highly valued).
- Excellent English communication; autonomy, leadership, and ability to work with diverse stakeholders.
Benefits (explicitly stated):
- At least 14 weeks’ gender-neutral parental leave; health and wellbeing benefits.