Sanofi · 12 hours ago
Clinical Research Director
Cambridge, MA
Full-time
Onsite
Lead/Staff, Director/Executive
2+ years expSanofi is an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. The Clinical Research Director will oversee the development and execution of clinical trials in the Immunology and Inflammation Therapeutic Area, ensuring compliance with regulatory standards and contributing to the clinical strategy and planning.
BiotechnologyHealthcarePharmaceuticalLife ScienceHealth CareTherapeutics
Responsibilities
Has and maintains deep scientific, technical and clinical expertise in the immunology/ transplant/ hematology field
Has a demonstrated track record in clinical development, with Phase 3 experience being an advantage
Understands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interest – Knowledge on antibody is a plus
Critically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive products
Maintains visibility within the immunology/ transplant field to maintain credibility with internal and external stakeholders
Contributes to the development of the clinical strategy and plan
Leads the development of the Abbreviated Protocol and Protocol development
Represents the clinical function on Clinical Study Teams and other teams as appropriate
Provides input into the Translational Medicine Plan that defines the biomarker strategy and other aspects to increase the knowledge about the pathway and effects of the drug
Ensure that all development activities are targeted towards timely achievement (e.g. Abbreviated Protocol and protocol before study start, committees management and centralized monitoring during study, and KRM & CSR preparation at study end)
Interacts with opinion leaders and external consultants
Represents the Division at key regulatory agency meetings as the medical spokesperson for the studies and project
Ensures clinical data meets all necessary regulatory standards
Supports registrations, label submissions and modifications (contributes to IB, DSUR, Briefing Package for Health Authorities)
Participates in Advisory Committee preparation
Ensures timely submission and dissemination of clinical data
Supports the planning of advisory board meetings
Establishes and maintains appropriate collaborations with knowledge experts
In addition to the above activities the CRD must ensure that all activities of the Global Project Team (GPT) are conducted in compliance with current regulations, laws and guidance from FDA, EMEA, and CHMP, as well as with Sanofi’s policies and procedures
Qualification
Required
Medical Doctor with hematology/ transplant clinical expertise preferred
At least 2 years' experience in pharmaceutical drug development or clinical research
Proven record of scientific achievement as evidenced by presentations and publications in peer-reviewed journals and/or successful completion of major clinical studies or submissions is a plus
Strong scientific and academic background with deep understanding of the disease
Clinical research or pharmaceutical experience medicine experience in the immunology/hematology/transplant field
Knowledge of drug development and in immunology/ hematology/ transplant
Good networking ability in cross-cultural environment
Strong interpersonal, communication, presentation, and negotiation skills across all levels of the organization
Performance oriented with ability to work along agreed timelines and a focus on strategy and execution
Fluent in English (verbal and written communication)
Benefits
High-quality healthcare
Prevention and wellness programs
At least 14 weeks’ gender-neutral parental leave
Company
Sanofi
Sanofi is a global biopharma company focused on prescription drugs, vaccines, and treatments for chronic, rare, and infectious diseases.
10001+ employees
H1B Sponsorship
Sanofi has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (101)
2024 (68)
2023 (59)
2022 (78)
2021 (38)
2020 (38)
Funding
Current Stage
Public CompanyTotal Funding
$6.98BKey Investors
Blackstone Life SciencesEvotec
2025-10-28Post Ipo Debt· $3B
2025-06-17Post Ipo Debt· $1.72B
2025-03-05Post Ipo Debt· $1.62B
Leadership Team
Paul Hudson
Chief Executive Officer
Francois-Xavier Roger
Chief Financial Officer
Recent News
2026-02-13
WSJ.com: US Business
2026-02-13
Company data provided by crunchbase