Senior Clinical Research Director
Sanofi
August 07, 2026
On-site
Cambridge, MA
$236,250 - $393,750 USD yearly
Clinical Research and Development
Role Responsibilities
- Report to Global Project Head (GPH) or Principal Clinical Lead (PCL); coordinate with CRDs, Pharmacovigilance, Regulatory, and key stakeholders.
- Provide medical expertise for clinical studies (excluding select Exploratory Pharmacology) and/or registries (e.g., protocol, Key Results, Clinical Study Report).
- Support clinical development activities (feasibility, medical review/validation of clinical data, study risk assessment).
- Contribute to Extended synopsis and Protocol; clinical submission dossier content (CTD for FDA/EMA, filings for Japan/China, health authority Q&A).
- Provide medical input/support for study-related activities (medical training, feasibility, data review, medical information for teams, investigators).
- Serve as medical reference for the Clinical Study team; ensure medical relevance of clinical data.
- Lead clinical development plan and clinical sections of integrated development plans (IDP).
- Review/validate protocols and amendments; review ICF/WSI and TDF; oversee timelines/budgets/contingency and execution in line with GCP/laws/SOPs.
- Lead study committees (e.g., IDMC, steering, adjudication); co-develop SAP with biostats; key results preparation; develop clinical study report.
- Regulatory/safety document contributions (e.g., clinical sections of IB, CTA, IND, DSUR, INDAR, DRMP, RMP; BLA/CTD clinical sections; briefing packages; PSP/PIP) and advisory committee preparation.
- Participate in manuscript/abstract authorship; support advisory board planning and collaborations; assist with ad hoc clinical advisory tasks.
Qualifications/Requirements & Skills
- MD (or equivalent).
- Fluent English (spoken/written).
- Medical Oncology or Hematology/Oncology specialist.
- At least 4 years in pharma/biotech clinical development.
- Computer skills.
- Strong scientific/medical expertise; expertise in clinical development and study methodology.
- Excellent communication across functions and with regulators; risk-management mindset; ability to negotiate resources.
- Teaching/training skills; matrix-model experience; international/intercultural working skills; open-mindedness to digital solutions.
Benefits (explicitly stated)
- Health and wellbeing benefits; at least 14 weeks gender-neutral parental leave.
Application Instructions
- Not specified.
- Report to Global Project Head (GPH) or Principal Clinical Lead (PCL); coordinate with CRDs, Pharmacovigilance, Regulatory, and key stakeholders.
- Provide medical expertise for clinical studies (excluding select Exploratory Pharmacology) and/or registries (e.g., protocol, Key Results, Clinical Study Report).
- Support clinical development activities (feasibility, medical review/validation of clinical data, study risk assessment).
- Contribute to Extended synopsis and Protocol; clinical submission dossier content (CTD for FDA/EMA, filings for Japan/China, health authority Q&A).
- Provide medical input/support for study-related activities (medical training, feasibility, data review, medical information for teams, investigators).
- Serve as medical reference for the Clinical Study team; ensure medical relevance of clinical data.
- Lead clinical development plan and clinical sections of integrated development plans (IDP).
- Review/validate protocols and amendments; review ICF/WSI and TDF; oversee timelines/budgets/contingency and execution in line with GCP/laws/SOPs.
- Lead study committees (e.g., IDMC, steering, adjudication); co-develop SAP with biostats; key results preparation; develop clinical study report.
- Regulatory/safety document contributions (e.g., clinical sections of IB, CTA, IND, DSUR, INDAR, DRMP, RMP; BLA/CTD clinical sections; briefing packages; PSP/PIP) and advisory committee preparation.
- Participate in manuscript/abstract authorship; support advisory board planning and collaborations; assist with ad hoc clinical advisory tasks.
Qualifications/Requirements & Skills
- MD (or equivalent).
- Fluent English (spoken/written).
- Medical Oncology or Hematology/Oncology specialist.
- At least 4 years in pharma/biotech clinical development.
- Computer skills.
- Strong scientific/medical expertise; expertise in clinical development and study methodology.
- Excellent communication across functions and with regulators; risk-management mindset; ability to negotiate resources.
- Teaching/training skills; matrix-model experience; international/intercultural working skills; open-mindedness to digital solutions.
Benefits (explicitly stated)
- Health and wellbeing benefits; at least 14 weeks gender-neutral parental leave.
Application Instructions
- Not specified.