Clinical Research Director

Sanofi; Vitry-sur-Seine; Sur place; EUR 120 000 - 150 000; Plein temps

Résumé du poste

Sanofi in Vitry-sur-Seine, France is seeking a Clinical Research Director to lead clinical trial strategy within the development team. You will report to the Global Project Head and drive development plans across functions to bring compounds through life cycle management.

The role requires strong oncology experience, leadership in late-stage trials, and collaboration with Regulatory, Biostatistics, and Translational Medicine to shape development strategy and study execution.

Qualifications

• Oncology training (medical oncology or hematology/oncology fellowship) or MD with experience (4+ years) required.
• Experience in late-stage development and proven ability to design and execute clinical trials.
• Strong cross-functional collaboration with Clinical Operations, Biostatistics, Regulatory, Translational Medicine and Project Management.

Responsabilités

• Establishes or adapts the clinical development plan for programs with investigators and regulatory authorities.
• Leads the execution of clinical development and study activities, including protocol reviews and amendments.
• Reviews informed consent forms, subject information and trial disclosures.
• Oversees study committees and interprets study results for clinical study reports and summaries.
• Provides clinical guidance to other functions (Clinical Operations, Biostatistics, Translational Medicine).
• Contributes to regulatory and safety documents and discussions.

Connaissances

Oncology

Cross-functional teamwork

External investigators collaboration

Regulatory compliance

Clinical trial design

Formation

Oncology training or MD

Description du poste

Clinical Research Director - Job Description

Job title:

Clinical Research Director

• Location : Vitry-sur-Seine, France
• Hiring Manager : Ray Perez

About The Job

Join the engine of Sanofi’s mission - where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

Reporting to the Global Project Head, the CRD leads clinical trial strategy of assigned program(s) within the clinical development team, including interactions with Clinical Operations, Biostatistics, Regulatory, Translational Medicine, Project Management, New Product Planning and Pharmacovigilance to establish the development strategy and execute the development plan. The clinical development team further develops a compound through life cycle management.

About Sanofi

We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main Responsibilities

Establishes or adapts clinical development plan for the program(s) including discussions with clinical investigators, advisors and regulatory authorities and plans contingencies.

Leads, supports and oversees the execution of clinical development and studies activities, including but not limiting to:

• Authors abbreviated protocol.
• Reviews the final protocol and protocol amendments.
• Reviews the Informed Consent Form, Written Subject Information and Trial Disclosure Form.
• Reviews the study specific committee charters. Leads study specific committees with operational support.
• Leads the clinical interpretation of study results, contributes to clinical study reports and clinical summaries.
• Provides effective clinical guidance to other functions, including Clinical Operations, Biostatistics and Translational Medicine

Participates and contributes to regulatory and safety documents and discussions

• Reviews and/or contributes clinical sections of the Investigator Brochure, IND/IMPD filings, DSUR, development risk management plans
• Contributes to the clinical sections of the NDA/CTD, Briefing packages for regulatory meetings, PSP/PIP
• Participates in Advisory Committee preparation

Scientific data evaluation and authorship

• Authors clinical abstracts, presentations for conferences, and manuscripts, when appropriate
• Supports the planning of advisory board meeting. Presents and discusses development strategy and clinical study result with external investigators and advisory boards, as appropriate

Experience

About you

• Oncology training (medical oncology or hematology/oncology fellowship) or MD with experience (4+ years) is required.
• Pharmaceutical experience is required, 3+ years strongly preferred.
• Experience in late-stage clinical development strongly preferred.
• Demonstrated experience in clinical trial design and execution.
• Proven track record of working effectively with multifunctional teams to achieve project milestones.
• While industry experience is preferred, candidates with demonstrated excellence in academic clinical research and documented achievements may be considered with relatively less industry experience.

Soft And Technical Skills

• Deep understanding of oncology, particularly solid tumor biology
• Demonstrated ability to interact productively with external investigators
• Demonstrated ability to work with a multifunctional team to achieve project milestones
• Understanding of and willingness to meet applicable regulatory, quality and compliance standards

Education

• Oncology training (medical oncology or hematology/oncology fellowship) or MD with experience (4+ years) is required.

Languages

• Fluency in spoken and written English required (for global collaboration with US and European teams). French: Not required (nice to have for France-based positions). Spanish: Not required (nice to have for Spain-based positions).

What we offer

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.