Global Clinical Development Strategy Expert
Sanofi
August 26, 2026
Remote friendly (Swiftwater, PA)
United States
$178,500 - $257,833.33 USD yearly
Clinical Research and Development
Role Summary:
Global Clinical Development Strategy Expert in Global Clinical Development, leading clinical development strategy and execution for clinical trials, primarily in Acne therapeutic vaccine development and New Targets projects.
Key Responsibilities:
- Define and present a strategic clinical development plan aligned with global R&D/franchise strategy and regulatory needs for governance endorsement.
- Lead the Clinical Team and support cross-functional areas (monitoring, data management, biostatistics, medical writing, pharmacovigilance, regulatory affairs).
- Manage clinical development from early-stage through licensure; provide 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 clinical trial 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 existing SOPs.
- Build and maintain networks of internal/external collaborators, opinion leaders, investigators, and competent authorities.
Qualifications & Experience:
- 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 expertise in vaccine/therapeutics development and clinical strategy (academia, non-profit, government, or industry).
- Experience with GCP/ICH.
- Proven ability to lead transversal teams; strong interpersonal skills.
- Experience with regulatory submissions and interactions with health authorities.
Skills (Preferred/Welcome):
- Background in clinical immunology (welcome).
- Expertise in Dermatology, Infectious Diseases, Pediatrics, or Internal Medicine (preferred).
- Therapeutic vaccine experience, especially dermatology (Acne) and later-stage development (highly valued).
- Excellent English oral/written communication.
- Autonomy, ability to drive change and empower others; work effectively with diverse stakeholders.
Benefits:
- Health and wellbeing benefits, including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.
Application Instructions:
- Ready to get started? Join Sanofi’s mission.
Global Clinical Development Strategy Expert in Global Clinical Development, leading clinical development strategy and execution for clinical trials, primarily in Acne therapeutic vaccine development and New Targets projects.
Key Responsibilities:
- Define and present a strategic clinical development plan aligned with global R&D/franchise strategy and regulatory needs for governance endorsement.
- Lead the Clinical Team and support cross-functional areas (monitoring, data management, biostatistics, medical writing, pharmacovigilance, regulatory affairs).
- Manage clinical development from early-stage through licensure; provide 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 clinical trial 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 existing SOPs.
- Build and maintain networks of internal/external collaborators, opinion leaders, investigators, and competent authorities.
Qualifications & Experience:
- 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 expertise in vaccine/therapeutics development and clinical strategy (academia, non-profit, government, or industry).
- Experience with GCP/ICH.
- Proven ability to lead transversal teams; strong interpersonal skills.
- Experience with regulatory submissions and interactions with health authorities.
Skills (Preferred/Welcome):
- Background in clinical immunology (welcome).
- Expertise in Dermatology, Infectious Diseases, Pediatrics, or Internal Medicine (preferred).
- Therapeutic vaccine experience, especially dermatology (Acne) and later-stage development (highly valued).
- Excellent English oral/written communication.
- Autonomy, ability to drive change and empower others; work effectively with diverse stakeholders.
Benefits:
- Health and wellbeing benefits, including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.
Application Instructions:
- Ready to get started? Join Sanofi’s mission.