Senior Clinical Research Director, Rare

Job Title: Senior Clinical Research Director – Cambridge, MA or Morristown, NJ About the Job Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI‑powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. As the Senior Clinical Research Director within the RARE Therapeutic Area, you will lead clinical development for one or several indications in the developmental program. The role requires medical leadership, organization skills and a strategic, operational focus. Main Responsibilities Provide medical expertise to the study team and conduct clinical studies from early phases to LCM programs. Collaborate with other medical and clinical scientific experts, DSDs, global safety officers, regulatory strategists and key functional representatives to deliver development strategy and prepare/assist regulatory interactions. Develop study‑level regulatory documentation (Abbreviated Protocol, Protocol, Amendment) and lead operational development activities such as pressure test, competitive intelligence, patient engagement, cluster feasibility, and study risk assessment. Provide appropriate medical input and support for all activities related to clinical study conduct, including responses to IRBs, HA questions, protocol scientific training, medical review of data, and collaboration with investigators. Develop the clinical portion of briefing regulatory documents, Common Technical Document for submission to FDA, EMA, PMDA, etc., and respond to authority questions. Serve as the medical reference in the Clinical Study team, ensuring medical relevance of data and mentoring other DMDs/DSDs/CSs in medical strategy. Key Responsibilities Lead clinical development plan strategies and prepare the clinical sections of integrated development plans (IDP). Contribute to the product value proposition (TVP), Target Product Profile (TPP) and market access strategy. Prepare internal governance documents and contribute to TPP, TVP and GPT documents related to indications. Collaborate with other DMDs/DSDs within the project, build consensus and coordinate action plans. Raise study or project‑level issues to the project head and propose corrective action plans. Collaborate with external partners, regulators, scientific experts and internal stakeholders. Provide operational expertise to the project clinical sub‑team as needed. Evaluate the relevant medical literature and competitive product status. Lead, support and oversee execution of clinical development and study activities. Communicate appropriately with all functional stakeholders and manage timelines, budgets, and risk plans. Develop protocols, informed consent forms, study committee charters, feasibility results and other clinical documents. Review and provide clinical input across different study documents and vendors’ RFPs. Provide medical/clinical input to study‑related documents such as study plans, risk management plans, monitoring plans, and training materials. Answer medical questions from Health Authorities, Ethics Committees, IRBs, and sites. Ensure quality of clinical data through continuous data validation and blinded data review. Ensure trial master file readiness and availability of mandatory trainings. Lead study‑specific committees (IDMC, steering committee, adjudication). Co‑Develop the Statistical Analysis Plan (SAP). Responsible for key results preparation and development/review of the clinical study report. Represent the project in regulatory interactions, write clinical sections of CTD, briefing documents, support registration and labeling, contribute to Investigator’s Brochure, CTA, IND, DSUR, DRMP, RMP, BLA/CTD, briefing packages and PSP/PIP. Ensure clinical data meets all necessary regulatory standards. Collaborate with Patient Safety GSO for safety signal detection and documentation. Assist advisory committee preparation and scientific data evaluation and authorship. Maintain collaborations with knowledge experts or advisory boards and serve as a clinical advisor to research teams. Qualifications Experience At least 4 years of experience in clinical development in the pharmaceutical industry, CRO, or medical experience in clinical development in a healthcare institution. Soft Skills Excellent verbal and written communication skills for functional and regulatory interactions. Exceptional problem‑solving and risk‑management capability. Quality‑focused, data‑driven and capable of developing good practices. Ability to handle multiple tasks and prioritize. Negotiation skills to secure operational resources. Mentoring skills and performance evaluation. Intercultural and international working skills. Openness to applying digital solutions. Technical Skills Understanding of pharmaceutical product development and life‑cycle management. Very good scientific and medical/clinical expertise. Expertise in clinical development methodology. Experience interacting with Health Authorities. Education Medical Doctor (MD) preferred: GP or specialist; training in pediatrics or pediatric neurology is a plus. Languages English fluent (spoken and written). Benefits & Compensation Salary range: $236,250.00 – $393,750.00, commensurate with experience. Health, wellness and preventive programs; at least 14 weeks of gender‑neutral parental leave. Eligibility for company employee benefits programs. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and affirmative action employers committed to a diverse and inclusive workforce. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, gender, sexual orientation, disability, veteran or military status, or any other characteristic protected by law. #J-18808-Ljbffr Sanofi