Senior Clinical Research Director, Rare

Job Title

Senior Clinical Research Director

Cambridge, MA or Morristown, NJ

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 (Senior CRD) within the RARE Therapeutic Area, you will be the expert clinical lead for one or several indications in the Development of an R&D program. The role requires medical leadership, organization skills and a strategically and operationally focused, resourceful individual. The Senior CRD shows capacity to arbitrate to create synergies within the team and with external stakeholders, very good emotional intelligence, self-motivation, solid analytical skills, and the ability to deliver multiple operational tasks.

Sanofi Global Development ambition is to be the industry-leading Development organization, using impactful therapeutic innovation that turns hope into reality for people. The RARE Therapeutic Area leads the development of therapies for rare inherited disorders by overseeing the portfolio of development projects and execution of the development programs through the multi-disciplinary Global Project Team (GPT). The Rare Neurometabolic Cluster oversees development projects and execution of the development programs of lysosomal storage with systemic and neurological manifestations, neuromuscular and neurodevelopmental disorders.

• 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, CRDs or DSDs in the project under the leadership of the Global Project Head, with the Global Safety Officer, Regulatory Strategist and other 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) for their project, lead other operational development activities pertaining to study start-up (e.g. pressure test, competitive intelligence, patient engagement, cluster feasibility, study risk assessment etc…)
• Provide appropriate medical input & 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 the Centralized monitoring, clinical and medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators
• Develop the clinical part of Briefing regulatory documents, Common Technical Document for submission to regulatory bodies (FDA, EMA, PMDA etc…) and answers to questions from health authorities.
• Be the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical data and able to act as mentor for other DMDs/DSDs/CSs, has the capacity to train them on the medical/scientific strategy by indication

• Responsible for the clinical development plans and clinical sections of integrated development plans (IDP)
• Contribute in the definition of the product value proposition (TVP), Target Product Profile (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
• Prepares Internal Governance documents and contributes to the medical aspects the TPP, TVP and other GPT documents related to one or several indications of the IDP in support of the GPH
• Collaborate with other DMDs/DSDs within the project, ensures leadership, builds consensus, coordinates action plans with stakeholders to resolve project-related issues, anticipates potential issues (sharing lessons learned) across the project or study teams
• Raise study or project-level issues to the project head and propose related corrective action plans
• Collaborates with external partners, regulators, scientific…