Senior Clinical Research Director

Sanofi•Morristown, MA

7d•Onsite

About The Position

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. We are looking for a Senior Clinical Research & Development (CRD) to join our Rheumatology/Transplant clinical development team, playing a pivotal leadership role in shaping and advancing our clinical programs. If you are a medically trained expert with a passion for immunoscience and a drive to mentor, collaborate, and innovate, this is your opportunity to make a meaningful impact at scale. 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. Together, we chase the miracles of science to improve people’s lives.

Requirements

Understanding of pharmaceutical product development and life cycle management gained through approximately 4 years of clinical development and medical experience.
Excellent scientific and medical/clinical expertise.
Excellent expertise in clinical development methodology and design of clinical studies.
Excellent communication skills (verbal and written) for interactions across functional areas and with key regulatory agencies.
Demonstrated capability to challenge decisions and the status quo with a risk-management approach.
Ability to negotiate to ensure operational resources are available for continued clinical conduct.
Fluency in written and spoken English.
Excellent teaching skills with a demonstrated ability to assist and train others.
Ability to work effectively within a matrix model.
Strong international/intercultural working skills.
Open-minded and adaptable to new digital solutions.
MD or equivalent medical degree is required (DO, MBBS).
Medical training or clinical development experience in rheumatology, hematology, transplant, or immunology.
At least 4 years in the pharmaceutical industry (experience in late-stage clinical development preferred).
English fluency (spoken and written).

Responsibilities

Serve as a senior medical and scientific leader within the Rheumatology/Transplant team.
Act as a mentor for other CRDs and Clinical Scientists within the same project or therapeutic area.
Provide leadership, build consensus, and coordinate action plans with other CRDs and stakeholders to resolve project-related study issues.
Anticipate potential issues by sharing lessons learned across project and study teams.
Raise study or project-level issues to TA Heads as relevant, and share pertinent information within and beyond project teams.
Collaborate with functions to ensure a uniform, aligned operational approach (e.g., harmonizing study documents, endpoints, protocols).
Interact with other CRDs in the project, Global Project Head, PV Representatives, Regulatory, and other key functional representatives.
Provide medical expertise to clinical studies (except select Exploratory Pharmacology studies) and/or registries, including protocol development, Key Results, and Clinical Study Reports.
Support other clinical development activities such as pressure testing and cluster feasibility, medical review and validation of clinical data, and study risk assessment.
Contribute to the clinical part of submission dossiers, including Common Technical Documents for FDA & EMA submissions, filings in Japan and China, and responses to health authority questions.
Provide appropriate medical input and support for all activities related to clinical studies, including medical training, feasibility assessments, medical review of data, and medical information for study teams, medical advisors, Clinical Project Leaders from Clinical Study Units, and investigators.
Serve as the medical reference within the Clinical Study team, ensuring the medical relevance and integrity of clinical data.