Clinical Research Director - Sanofi : Job Details

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 Investigators 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, inte...Clinical Research, Director, Clinical, Research, Development, Regulatory Affairs, Healthcare