Clinical Research Director

Clinical Research Director – Job description

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

• 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.

• 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

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

• 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.

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.