Clinical Development Director — Immunology

Job title Development Medical Director (DMD) Location Cambridge, MA / 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. Our Team To support sustainable growth Sanofi Global Development ambition is to be the industry‑leading Development organization, using impactful therapeutic innovation that turns hope into reality for people. Therapeutic Areas lead the development of therapies by overseeing the portfolio of development projects and execution of the development programs through the multidisciplinary Global Project Team (GPT). Role Overview The Development Medical Director (DMD) is the medical expert in the Development of R&D programs. The role requires a well‑organized, strategically and operationally focused, resourceful individual with very good emotional intelligence, self‑motivation, solid analytical skills, and the ability to deliver to multiple tasks. Our Project Lunsekimig is a novel bi‑specific nanobody targeting both TSLP and IL‑13. Lunsekimig is in development across multiple immunology disease areas. We are seeking a highly motivated clinician‑scientist to lead clinical trials in the respiratory space. About Sanofi Sanofi is an R&D‑driven, AI‑powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Main responsibilities Provide medical expertise in the Study team to conduct the clinical studies from early phases to LCM programs. Collaborate with other medical and clinical scientific experts (DMDs, DSDs) under the leadership of the Global Project Head and key functional representatives to deliver development strategy and prepare/assist with regulatory bodies interaction. Develop the study‑level regulatory documentation (Abbreviated Protocol, Protocol, Amended protocol) and lead other development activities pertaining to study start‑up. Provide appropriate medical input and support for all activities related to clinical studies conduct such as answers to IRBs and HA questions, protocol scientific and medical training, medical review of data within the scope of centralized monitoring, clinical and medical information for the study team, and investigators. Contribute to the clinical part of Common Technical Document for submission to regulatory bodies (FDA, EMA, PMDA) and answer questions from health authorities. Serve as the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical data. Key responsibilities include: Leading the clinical development plan strategies Responsible for the clinical development plans and clinical sections of integrated development plans (IDP). Collaborate with other DMDs/DSDs within the project, build consensus and coordinate action plans with stakeholders to resolve project‑related issues and anticipate potential issues. Raise study or project‑level issues to the project head and propose corrective action plans. Contribute to the definition of the product value proposition, Target Product Profile (TPP) and market access strategy, and provide input on existing clinical needs and approaches to clinical development strategies for research projects. Collaborate with external partners, regulators, scientific experts and internal stakeholders. Provide operational expertise to the project clinical sub team as needed. Evaluate relevant medical literature and status from competitive products. Lead, Support and oversee the execution of clinical development and studies Collaborate and communicate appropriately with all function stakeholders and responsible for timelines, budgets and contingency/risk management plans. Develop abbreviated protocol, the final protocol and protocol amendments. Develop and review the Core Study Informed Consent Form, Study Committee Charters and key medical and clinical questions with the Global feasibility manager. Review and provide clinical input across study documents (Vendors RFPs, e‑CRF, eCOA). Provide medical/clinical input to study‑related documents such as study plans, risk management plan, monitoring plans. Participate in the elaboration of training material and presentations at investigator meetings and local teams trainings. Answer medical questions raised by HA, EC/IRBs, sites. Ensure quality of clinical data through continuous data validation and blinded data review during clinical trial conduct. Ensure trial master file documents readiness and mandatory trainings linked to the clinical function. Lead study specific committees (IDMC, steering committee, adjudication) with operational support. Co‑develop the SAP in collaboration with the biostatistical team. Develop and review the clinical study report. Responsibilities related to regulatory and safety documents and meetings Review and contribute to the clinical section of the Investigator’s brochure, CTA, IND, DSUR, DRMP, RMP. Write and review the clinical sections of the BLA/CTD, briefing packages and PSP/PIP. Ensure clinical data meets all necessary regulatory standards. Collaborate with the Patient Safety GSO to detect and document any safety signal. Participate in Advisory Committee preparation. Scientific Data evaluation and authorship Participate and author manuscripts and abstracts. Establish and maintain collaborations with knowledge experts or advisory boards. Contribute on an ad hoc basis to specific tasks such as evaluation of potential licensing candidates and serve as the clinical advisor to research teams. About you Experience At least 3 years previous experience in clinical development in the pharmaceutical industry or a CRO or medical experience in clinical development in a healthcare institution. Background in respiratory, allergy or immunology preferred. Soft skills Very good communication skills for interactions across functional areas and with key regulatory agencies. Excellent problem‑solving capability. Demonstrated capability to challenge decision and status quo with a risk‑management approach. Ability to negotiate to ensure operational resources are available for continued clinical conduct. Very good teaching skills, demonstrated ability to assist and train others. Ability to work within a matrix model. International/intercultural working skills. Open‑minded to apply new digital solutions. Technical skills Understanding of pharmaceutical product development and life‑cycle management. Very good scientific and medical/clinical expertise. Very good expertise in clinical development and methodology of clinical studies. Education MD (Doctor of Medicine) or equivalent patient‑care related medical degree (DO, international equivalents, etc.) required. Languages English fluent (spoken and written). Why Choose Us? Bring the miracles of science to life alongside a supportive, future‑focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well‑crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high‑quality healthcare, prevention and wellness programs and at least 14 weeks’ gender‑neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and affirmative action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital, domestic partnership or civil union status, sex, gender, gender identity or expression, affectional or sexual orientation, disability, veteran or military status or liability for military status, domestic violence victim status, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. The salary range for this position is $206,250.00 - $297,916.66. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in company employee benefit programs. Additional benefits information can be found through the provided links. #J-18808-Ljbffr Mass Digital Health