Sanofi · 1 day ago
Senior Clinical Research Director, I&I
Bridgewater, NJ
Full-time
Onsite
Lead/Staff, Director/Executive
4+ years expSanofi is an innovative global healthcare company dedicated to improving people’s lives through science. The Senior Clinical Research Director will act as the primary clinical lead for programs, providing medical expertise and collaborating with various functions to ensure effective project execution.
Health CareLife SciencePharmaceuticalTherapeutics
Responsibilities
Act as a mentor for other CRDs and Clinical Scientists on a same project/TA
Collaborate with functions to ensure uniform, aligned operational approach (e.g harmonizing study documents, ES, protocols, etc). As relevant, within a project, ensure leadership, build consensus, coordinate action plans with other CRDs and stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams. He/she raises study or project-level issues to TA Heads, as relevant and shares relevant information within and beyond Project teams
Provide medical expertise to the clinical studies (except select Exploratory Pharmacology studies) and/or registries (eg: protocol, Key Results, Clinical Study Report)
Support other clinical development activities (e.g. pressure test and cluster feasibility, medical review and validation of clinical data, study risk assessment)
Contribute to the clinical part of submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions from health authorities
Provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators
Internal Governance: Preparation of Documents and Presentations for Internal Governance Meetings
Contribute in the definition of the product value proposition (TVP), TPP and market access strategy (in collaboration with respective functions) and the focus of the research strategy, by providing input on existing clinical needs and approaches to clinical development strategies for research projects
Represents his/her project at key regulatory agency meetings as the medical spokesperson for the studies and project Lead the strategy and structure of the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP Supports registrations, label submissions and modifications Take on as necessary the CRD role
Review and/or contribute in the the clinical section of the Investigator’s brochure, CTA, IND, DSUR, INDAR, DRMP, RMP
Contribute on an ad hoc basis to specific tasks such as the evaluation of potential in-licensing candidates for I&I therapeutic area and serves as the clinical advisor to research teams
Qualification
Required
At least 4 years in pharmaceutical industry or CRO, previous experience in clinical development
Preferred
Medical Doctor (MD) preferred: GP or specialist, English fluent (spoken and written)
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
$6.97BKey Investors
Blackstone Life SciencesEvotec
2025-10-28Post Ipo Debt· $3B
2025-06-17Post Ipo Debt· $1.74B
2025-03-05Post Ipo Debt· $1.59B
Leadership Team
Paul Hudson
Chief Executive Officer
Francois-Xavier Roger
Chief Financial Officer
Recent News
2026-01-06
BioWorld Financial Watch
2026-01-06
2026-01-06
Company data provided by crunchbase