Clinical Research Director

Job Title: Clinical Research Director

Location: Morristown, NJ Cambridge, MA

About the Job

Ready to push the limits of what’s possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world.

The Clinical Research Director (CRD), Immunology & Inflammation (I&I) Therapeutic Area 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 for immunology in Dermatology,  incorporate new methodologies and pro-actively progress study execution. 

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?  

Main Responsibilities:

• Create the clinical development strategy for one or more assets and document it in the clinical development plan in collaboration with the global project team and internal partners such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing.

• Advance the CDP through internal management review.

• Leads a clinical subteam to design clinical studies and to create an abbreviated and full clinical study protocol.

• 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.

• Support drug registrations (contribution to submission dossiers label draft, regulatory response during the review process, Advisory Committee preparation).

• Contribute to data review, interpretation and publication of clinical study results.

• Represent Clinical Development at Health Authorities and incorporating advise into development strategy.

• Maintain or establish interaction with external scientific and clinical communities and to incorporate pertinent advice and learnings into the internal program.

• Align company position on clinical strategy with partner in alliance projects.

• translate biology into clinic in close collaboration with research and translational medicine.

• evaluate clinical aspects of business development opportunities as needed.

• apply high ethical standards and work with integrity.

Scientific and Technical Expertise:

• This position requires a strong scientific and clinical foundation in dermatology.  Advanced leadership skills and the ability to effectively collaborate with external partners, regulators, and diverse internal stakeholders and collaborators are essential prerequisites.

• Be experienced in advancing assets from discovery into clinical development.

• Have experience in novel approaches in translational medicine.

• Have and maintain deep scientific, technical and clinical knowledge in Dermatology.

• Demonstrated problem solving skills.

• Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule of interest and the respective therapeutic area.

• Be able to translate current understanding of disease pathogenesis into functional consequences