Director, Early Clinical Development – Immunology, MD
Bristol Myers Squibb
Google Cloud Platform
Medical Director / Senior Medical Director, Clinical Development
PATHOS
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteJob Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Design, execution, oversight, and analysis of clinical trials
- Medical monitoring and medical review of trial data, including reviewing eligibility data
- Clinical site interactions: address medical questions, provide site education, safety management, and assess safety-related SAEs
- Draft clinical protocols and provide medical strategic oversight of protocol development (study design, patient populations, eligibility, safety risks & mitigation)
- Fulfill GCP and compliance obligations and maintain required training
- Contribute to Clinical Strategy and Clinical Development Plans for company assets
- Provide oversight and medical accountability for clinical trials
- Identify and build relationships with principal investigators and KOLs; support novel clinical trial designs and statistical analyses
- Support executional delivery of clinical studies (site activation, enrollment status, adjudication for protocol violations, medical validation/data clean-up)
- Interact with Health Authorities & IRBs/ECs as Clinical Program Lead
- Draft and author clinical content for CSRs, regulatory reports, briefing books, and submission documents
- Stay current on competitive compounds and provide recommendations on strategy changes
- Maintain clinical and scientific reputation in pertinent modalities and diseases
- Report to the Head of Clinical Development and collaborate with R&D, Translational Medicine, Biomarker, and cross-functional teams
Requirements
- MD is required (or a US-equivalent)
- Sub-specialty training in Medical Oncology (preferred)
- 5 or more years of Biotech/Pharma industry experience in Oncology Clinical Trial development and execution, preferably in solid tumors in Phase I/II/III
- Experience in the drug development process, delivering and executing on effective clinical trial plans and protocols
- Leadership and mentorship skills with a hands-on (working leader) approach
- Proven ability to lead teams, especially in a remote/virtual environment, and cross-functionally
- Ability to travel up to 30% (domestic and international)
- Knowledge of GCP and compliance obligations for clinical conduct
