Clinical Research Director

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.

Job title

Location: Cambridge, MA

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.

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.

• 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

• MD degree or equivalent.
• Hematology/Oncology fellowship or minimum 4 years experience in Oncology Development.
• Expertise in pharmaceutical medicine based on minimum 3 years industry or academic clinical research experience.
• Experience in late-stage clinical development preferred.
• 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.

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.
• Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
• Help improve the lives of millions of people globally by making drug development quicker and more effective.
• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.