Senior Medical Director, Early Clinical Development
900 Chesapeake Drive Redwood City, CA 94063 US
Job Description
The Position
Reporting directly to the VP, Clinical Development, the candidate will assume the primary role of providing clinical oversight for one or more early-phase clinical trials.
Key Responsibilities
• Drive clinical trial protocol development and execution through regulatory filings
• Provide clinical leadership to allow for initiation of US and global trials in collaboration with regulatory and clinical operations team members
• Interact seamlessly with biomarker translational scientists to inform and refine clinical product development and strategy
• Participate in the development of the clinical strategic plan for Bolt pipeline
• Prepare, present, and manage materials for external advisory boards to guide protocol and product development
• Provide medical guidance to investigators on managing patients on clinical protocols
• Oversee clinical data and safety assessments
• Medical Monitoring
• Participate as the medical monitor on study teams and lead the development of clinical protocols required to support product development, validation, and commercialization; including, but not limited to, the adoption and development of novel approaches for the demonstration of clinical validation and utilit
• Provide the overall strategic clinical direction and medical leadership for Oncology development-stage programs, serving as the medical expert on all clinical and medical matters
Job Requirements
• Medical Degree (MD) from a recognized academic institution with 6-8 years of experience in the pharmaceutical industry
• Oncology board certification and holds a license to practice medicine
• Strong track record in solid tumor clinical trials, experience in early phase oncology trials
• Experience establishing and working with various committees, such as data monitoring committees, safety review committees
• Record of excellence in patient care
• Strong communication, organization, and interpersonal skill
• Proven track record in managing clinical trials
*300k-375k range
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