Clinical Research Director

Overview

Job Title: Clinical Research Director

Location: Cambridge, MA, Morristown, NJ

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.

• 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 limited 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 results with external investigators and advisory boards, as appropriate.

• MD degree or equivalent, with Medical Oncology fellowship. Hematology/Oncology fellowship or experience (4+ years) in Oncology Development
• Expertise in pharmaceutical medicine based on industry experience (3+ years) or academic clinical research experience (3+ years)
• Experience in clinical development, late-stage 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

• 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.

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.