Clinical Research Director
Sanofi
August 07, 2026
Remote friendly (Cambridge, MA)
United States
$206,250 - $343,750 USD yearly
Clinical Research and Development
Main Responsibilities
- Establish or adapt clinical development plan for program(s), including discussions with clinical investigators, advisors, and regulatory authorities, and plan contingencies.
- Lead, support, and oversee clinical development and study execution, including:
- Author abbreviated protocol; review final protocol and amendments.
- Review informed consent form, written subject information, and trial disclosure form.
- Review study-specific committee charters; lead study-specific committees with operational support.
- Lead clinical interpretation of study results; contribute to clinical study reports and clinical summaries.
- Provide clinical guidance to Clinical Operations, Biostatistics, and Translational Medicine.
- Contribute to regulatory and safety documents/discussions:
- Review and/or contribute clinical sections of Investigator Brochure, IND/IMPD filings, DSUR, and development risk management plans.
- Contribute clinical sections of NDA/CTD, briefing packages for regulatory meetings, PSP/PIP.
- Participate in Advisory Committee preparation.
- Scientific Data Evaluation and Authorship:
- Author clinical abstracts, conference presentations, and manuscripts (as appropriate).
- Support advisory board planning; present/discuss development strategy and clinical study results.
Qualifications
- MD degree or equivalent.
- Hematology/Oncology fellowship OR minimum 4 years experience in Oncology Development.
- Expertise in pharmaceutical medicine with at least 3 years industry or academic clinical research experience.
- Experience in late-stage clinical development preferred.
- Demonstrated ability to interact with external investigators and work with multifunctional teams; understanding of regulatory, quality, and compliance standards.
Benefits (as stated)
- Health and wellbeing benefits, including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.
- Establish or adapt clinical development plan for program(s), including discussions with clinical investigators, advisors, and regulatory authorities, and plan contingencies.
- Lead, support, and oversee clinical development and study execution, including:
- Author abbreviated protocol; review final protocol and amendments.
- Review informed consent form, written subject information, and trial disclosure form.
- Review study-specific committee charters; lead study-specific committees with operational support.
- Lead clinical interpretation of study results; contribute to clinical study reports and clinical summaries.
- Provide clinical guidance to Clinical Operations, Biostatistics, and Translational Medicine.
- Contribute to regulatory and safety documents/discussions:
- Review and/or contribute clinical sections of Investigator Brochure, IND/IMPD filings, DSUR, and development risk management plans.
- Contribute clinical sections of NDA/CTD, briefing packages for regulatory meetings, PSP/PIP.
- Participate in Advisory Committee preparation.
- Scientific Data Evaluation and Authorship:
- Author clinical abstracts, conference presentations, and manuscripts (as appropriate).
- Support advisory board planning; present/discuss development strategy and clinical study results.
Qualifications
- MD degree or equivalent.
- Hematology/Oncology fellowship OR minimum 4 years experience in Oncology Development.
- Expertise in pharmaceutical medicine with at least 3 years industry or academic clinical research experience.
- Experience in late-stage clinical development preferred.
- Demonstrated ability to interact with external investigators and work with multifunctional teams; understanding of regulatory, quality, and compliance standards.
Benefits (as stated)
- Health and wellbeing benefits, including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.