Clinical Research Director (CRD), Rare Diseases

Job Title: Clinical Research Director (CRD), Rare Diseases

Grade: L4

Hiring Manager: Michelle Lee

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.

The Clinical Research Director (CRD), Rare Diseases Therapeutic Area, is responsible for creation and execution of the clinical development strategy for assigned projects/studies in this Therapeutic Area (TA). The CRD is responsible for the creation of the clinical development plan in alignment with the project strategy, its endorsement by governance and its execution in close collaboration with clinical operations. The CRD is expected to advance scientific and clinical knowledge and lead clinical study development in alignment with the asset scientific and business strategy. The role will support developing innovative therapies, particularly with an initial focus in the pulmonary space. The CRD is expected to contribute to the growth of the Rare Blood Disorders TA by both being a driver of clinical and scientific knowledge and advancing operational capabilities.

About Sanofi:
We’re 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.
 

Main Responsibilities:

• Create clinical development strategy and plans for one or more assets

• Lead and coordinate cross-functional teams to design, implement, and execute clinical development plans and studies 

• Align clinical development strategy with the global project team and internal partners, such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing

• Advance the clinical development plan through internal management review

• Lead a clinical sub team to design clinical studies and to create study protocols

• Execute the clinical development plan in close collaboration with clinical operations

• Advance scientific and clinical knowledge in rare diseases

• Incorporate new trial, scientific and digital methodologies

• Pro-actively progress study execution

• Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations

• Review documents supporting clinical development such as Investigator’s brochure, regulatory documents for IND / CTA, clinical sections of integrated development plans, and submission dossiers for regulatory approval

• Engage with health authorities (contribute to health authority submissions (such as new drug application) and timely response to regulatory reviews)

• Serve as a medical expert and provide strategic input to early-stage programs  

• Collaborate with external experts, key opinion leaders, and investigators to advance clinical research 

• Represent Sanofi at scientific conferences and regulatory meetings

Scientific and Technical Expertise:

• Has and maintains deep scientific, technical and clinical expertise in the therapeutic area

• Understands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interest

• Critically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive products

• Maintains visibility within the Therapy therapeutic area to maintain credibility with internal and external stakeholders

On Clinical Development, the CRD:

• Designs the global clinical development strategy (in close cooperation with other members of the team, particularly Regulatory Affairs end Health Economics) and leads the clinical development with regard to ongoing development activities and planned LCM for labelling changes

• Assessment of the Clinical benefit –risk profile during development and LCM on an ongoing basis, in strong collaboration with GPE and the CSO team

• Provides clinical input to the Target Product Profile

• Adjusts and updates the clinical strategy when necessary according to the project progression and infor