Global Clinical Development Strategy Expert

As a Global Clinical Development Strategy Expert within our Global Clinical Development Department, you will be a key member of the Project Team and Clinical Team, responsible for clinical development strategy and execution in the context of Acne therapeutic vaccine development and New Targets projects, with potential extension to other vaccine areas.

Responsibilities

• Define the strategic clinical development plan in line with global R&D strategy, franchise strategy, and regulatory needs, and present for endorsement with appropriate governance committees.
• Lead the Clinical Team and support different functions (monitoring, data management, biostatistics, medical writing, pharmacovigilance, regulatory affairs) with expertise and leadership.
• Manage the clinical development process from early-stage development through licensure, providing clinical leadership for evidence generation that supports licensure and commercialization.
• Work closely with the pharmacovigilance department to define safety surveillance processes during clinical development and design the safety risk management plan.
• Lead preparation of key clinical documents for clinical trials (protocols, reports), CTD submissions, and interactions with governance bodies, external experts, and competent authorities.
• Ensure operational development processes align with Sanofi Standard Operating Procedures and help review and improve current SOPs.
• Build and maintain a strong network of internal and external collaborators, opinion leaders, investigators, and competent authorities.

Requirements

• MD with specialization in Dermatology, Infectious Diseases, Pediatrics, Internal Medicine, or related field; or PhD in a life science area (Biology, Immunology, Pharmacology, or related field) with extensive clinical development experience.
• 5-10+ years of experience in clinical development with demonstrated expertise in vaccine or therapeutics development and clinical strategy in academia, non-profit, government, or industry.
• Experience working according to GCP/ICH guidelines.
• Proven ability to lead and manage transversal teams with excellent interpersonal skills.
• Experience with regulatory submissions and interactions with health authorities.

Skills

• Background in clinical immunology is welcome.
• Expertise in Dermatology, Infectious Diseases, Pediatrics, or Internal Medicine preferred.
• Experience with therapeutic vaccines, particularly for dermatological conditions such as Acne, and any later stage development is highly valued.
• Excellent oral and written communication skills in English.
• Considerable degree of autonomy with ability to act for change and empower others.
• Ability to work in diverse environments with different stakeholders.

Benefits

• Structured career paths designed for both scientific and leadership advancement.
• Opportunities to collaborate beyond your area of expertise with diverse teams across science, clinical, and digital fields.
• Thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.

Sanofi is an R&D-driven, AI-powered biopharma company committed to improving lives through innovative medicines and vaccines. We offer a supportive, future-focused team environment with opportunities for growth at home or internationally.