Metacrine is a dynamic, clinical-stage biotech company headquartered in San Diego, CA. The company is focused on building an innovative pipeline of drugs to treat liver and gastrointestinal (GI) diseases.
We are looking for a highly motivated individual to lead Clinical Operations. Reporting to the Chief Medical Officer, the Executive Director of Clinical Operations (EDCO) will provide strategic leadership of all clinical operations activities at Metacrine. Additionally, the EDCO will manage and foster the growth of the clinical operations group.
- Support and supervise the activities of direct reports in trial conduct
- If appropriate, assume lead operational role in select studies
- Identify and resolve clinical operations issues related to data management, monitoring, timelines, drug distribution, safety assessment, regulatory compliance, and review of trial master files
- Partner with clinical development scientists/physicians to ensure successful data collection, analysis, and reporting
- Proactively manage trial timelines and budgets to ensure that studies are completed on-time and within budget
- Ensure compliance of clinical study sites to protocols and applicable regulations
- Bachelor’s degree in a field related to biomedical research
- 10+ years in clinical operations/development, with 3+ years in a start-up biotech environment
- Prior therapeutic experience in liver, GI or metabolic diseases a plus
- Knowledgeable with FDA and EMA regulations, Good Clinical Practice, and ICH guidance
- Proven ability to work collaboratively in a fast-paced, matrix environment
- Established track record in CRO/vendor management, including timeline/budget management and d negotiation skills
- Managerial experience in recruiting, motivating and mentoring the growth of clinical operations team members
- 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.