Clinical Research Director
Sanofi
August 29, 2026
On-site
Cambridge, MA
$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, regulatory authorities, and contingency planning.
- Lead, support, and oversee execution of clinical development and studies activities, including:
- Author abbreviated protocol; review final protocol and protocol 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.
- Participate in regulatory and safety documents/discussions, including review/contribution to clinical sections of Investigator Brochure, IND/IMPD filings, DSUR, development risk management plans; contribute to NDA/CTD clinical sections, regulatory meeting briefing packages, and 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 with external investigators and advisory boards (as appropriate).
Qualifications:
- MD degree or equivalent.
- Hematology/Oncology fellowship or minimum 4 years’ Oncology Development experience.
- Minimum 3 years industry or academic clinical research experience; expertise in pharmaceutical medicine.
- Experience in late-stage clinical development (preferred).
- Demonstrated ability to interact productively with external investigators.
- Demonstrated ability to work with cross-functional teams to achieve project milestones.
- Understanding of and willingness to meet applicable regulatory, quality, and compliance standards.
Benefits:
- Health and wellbeing benefits, including high-quality healthcare and prevention/wellness programs; at least 14 weeks’ gender-neutral parental leave.
- Establish or adapt clinical development plan for program(s), including discussions with clinical investigators, advisors, regulatory authorities, and contingency planning.
- Lead, support, and oversee execution of clinical development and studies activities, including:
- Author abbreviated protocol; review final protocol and protocol 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.
- Participate in regulatory and safety documents/discussions, including review/contribution to clinical sections of Investigator Brochure, IND/IMPD filings, DSUR, development risk management plans; contribute to NDA/CTD clinical sections, regulatory meeting briefing packages, and 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 with external investigators and advisory boards (as appropriate).
Qualifications:
- MD degree or equivalent.
- Hematology/Oncology fellowship or minimum 4 years’ Oncology Development experience.
- Minimum 3 years industry or academic clinical research experience; expertise in pharmaceutical medicine.
- Experience in late-stage clinical development (preferred).
- Demonstrated ability to interact productively with external investigators.
- Demonstrated ability to work with cross-functional teams to achieve project milestones.
- Understanding of and willingness to meet applicable regulatory, quality, and compliance standards.
Benefits:
- Health and wellbeing benefits, including high-quality healthcare and prevention/wellness programs; at least 14 weeks’ gender-neutral parental leave.