Clinical Research Director

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

About you

Experience:

• 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.

Chez Sanofi, la diversité et l’inclusion sont au cœur de notre fonctionnement et sont intégrées à nos Valeurs fondamentales. Nous sommes conscients que pour exploiter véritablement la richesse que la diversité nous apporte, nous devons faire preuve d'inclusion et créer un environnement de travail où ces différences peuvent s'épanouir et être développées pour améliorer le quotidien de nos collègues, patients et clients. Nous respectons et valorisons la diversité de nos collaborateurs, leurs parcours et leurs expériences dans un objectif d’égalité des chances pour tous.

Dans le cadre de son engagement diversité, Sanofi accueille et intègre des collaborateurs en situation de handicap.

The salary range for this position is :€76 000,00 - €101 333

La rémunération finale sera déterminée en fonction de l'expérience démontrée, des compétences, de la localisation et d'autres facteurs pertinents. Les employés peuvent être éligibles pour participer aux programmes d'avantages sociaux de l'entreprise.