Senior Clinical Research Director, I&I (GI)
Sanofi
- Cambridge, MA
- Permanent
- Full-time
- Manage, coach and lead a team of Clinical Research Directors and Clinical scientists in the Early Development Team
- Develop strategies and clinical development plans for one or more early programs and support their implementation
- Support resources planning across the entire team
- Collaborate with functions to ensure an uniform, aligned operational approach. Within a project, ensure leadership, build consensus, coordinate action plans with the respective GPH and other CRDs and stakeholders to resolve project-related study issues and anticipate potential issues
- Lead clinical activities:
- Provide clinical expertise
- Support study related clinical activities, interaction with Health Authorities, provide medical input and support for all activities related to clinical studies
- Support BD activities as needed
- Supervise and manage Clinical Research Directors and Clinical Scientists to ensure appropriate support of projects within the pipeline
- Train and coach Clinical Research Directors and Clinical Scientists on all aspects of clinical development, implementation, and execution of clinical studies
- Assure adequate resourcing across projects
- Translate mechanism-of-actions into a clinical strategy by validating indications and development of a competitive clinical plan
- Support governance meetings through preparation of documents and presentations as needed
- Engage and collaborate with internal and external partners, regulators, and experts
- Develop protocols and execute phase 2 studies
- Assure successful execution of the clinical trials in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs)
- Publish and present study results and other data
- Clinical development in the field of immune driven diseases
- Understanding of pharmaceutical product development and life cycle management gained through ~5 years of development and medical experience
- Excellent communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies
- Strategic leadership and understanding of the drug development value chain
- Excellent teaching skills, demonstrated ability to assist and train others
- Ability to work within a matrix model
- International/ intercultural working skills
- Open-minded to apply new digital solutions
- Medical Doctor (MD): Gastroenterologist and/or experience in internal medicine and immune driven diseases
- Fluency in written and spoken English