Metacrine is a dynamic, clinical-stage biotech company headquartered in San Diego, CA. The company is focused on building an innovative pipeline of best-in-class drugs to treat liver and gastrointestinal (GI) diseases.
We are looking for an Executive Director of Clinical Development (EDCD). This highly motivated individual will report to the Chief Medical Officer and be a key member of the clinical and development teams. In addition to leading the planning and execution of clinical trials, the EDCD will maintain external collaborations with Key Opinion Leaders (KOL) and provide input for relevant documents such as Clinical Protocols, Investigator Brochures, Clinical Trial Applications and IND filings.
- Lead developer of clinical trial protocols, study reports, and relevant regulatory/ethics committee documents
- Joint responsibility with clinical operations in selecting and managing contract research organizations (CROs) and other study vendors
- Planning and managing advisory boards, investigators meetings, and other clinical/scientific events
- Development and execution of clinical data communication/publication plan
- Collaboration with pre-clinical colleagues to assess the need for and design of appropriate preclinical experiments to support the development plan
- Analyses of development strategies and options for discovery pipeline programs
- MD or PhD in a field related to biomedical research
- 10+ years in clinical science/research/development, with 3+ years in a start-up biotech environment
- Prior therapeutic experience in liver, GI or metabolic diseases a plus
- Prior success in clinical trial design, data analysis, interpretation and clinical relevance
- Knowledgeable with FDA and EMA regulations, Good Clinical Practice, and ICH guidance
- Clear and precise verbal, presentation, and writing skills
- Proven ability to work collaboratively in a fast-paced, matrix environment
- Track record of creative problem-solving
- Ability to “roll up your sleeves” and individually contribute to specific timelines and goals
- Able to travel in U.S. and international up to 20% of the time
To apply for this position please submit a resume to firstname.lastname@example.org naming the position in the subject heading.