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Senior Medical Director, Early Clinical Development

Redwood City, CA 94063

Posted: 11/01/2023 Employment Type: Direct Hire/Perm Job Category: Medical Affairs Job Number: 591339 Is job remote?: No Country: United States

Job Description

Senior Medical Director, Early Clinical Development

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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