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Senior Medical Director, Late Development
Job
GQR
South San Francisco, CA (In Person)
Full-Time
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Job Description
Senior Medical Director - Clinical Development Position Summary A biotechnology organization focused on advancing precision medicine in oncology is seeking a Senior Medical Director to join its Clinical Development team. This individual will provide medical leadership across clinical programs, including trial design, protocol development, medical monitoring, data analysis, and preparation of regulatory documentation. The role may also include serving as a Development Project Leader, partnering cross?functionally to ensure successful execution of clinical strategy and study operations. This position is based onsite four days per week at the company's headquarters in the San Francisco Bay Area. Key Responsibilities Clinical Strategy & Trial Development Apply disease?area expertise to guide clinical research strategy and trial development Lead protocol development in collaboration with Clinical Operations and cross?functional partners Drive creation and refinement of clinical development plans Regulatory & Scientific Documentation Partner with Regulatory Affairs to draft and review clinical sections of regulatory submissions (e.g., NDA, Investigator Brochures, Annual Reports, Health Authority submissions) Contribute to Clinical Study Report (CSR) development and finalization Support development of case report forms (CRFs) and data review plans Medical Monitoring & Data Review Monitor and interpret safety and efficacy data from ongoing clinical studies Serve as the primary clinical contact for trial sites, including eligibility assessments and AE management Scientific Communication & External Engagement Develop clinical abstracts and present data at scientific meetings, site initiation visits, and protocol trainings Participate in advisory boards and scientific discussions Cross?
Functional Leadership Represent Clinical Development on internal project teams Collaborate with Business Development as the clinical subject matter expert Requirements Medical degree (MD or equivalent) required Experience in Phase 3 clinical trial design, conduct, and execution preferred Strong understanding of oncology clinical trial design across Phases 1-3 Experience with clinical data monitoring and comprehensive knowledge of drug development processes Familiarity with GCP and ICH guidelines Demonstrated ability to build strong cross?functional relationships Critical thinker with a solutions?oriented mindset Self?motivated, adaptable, and effective in a dynamic, fast?paced environment Strong organizational skills and ability to navigate conflict constructively
Functional Leadership Represent Clinical Development on internal project teams Collaborate with Business Development as the clinical subject matter expert Requirements Medical degree (MD or equivalent) required Experience in Phase 3 clinical trial design, conduct, and execution preferred Strong understanding of oncology clinical trial design across Phases 1-3 Experience with clinical data monitoring and comprehensive knowledge of drug development processes Familiarity with GCP and ICH guidelines Demonstrated ability to build strong cross?functional relationships Critical thinker with a solutions?oriented mindset Self?motivated, adaptable, and effective in a dynamic, fast?paced environment Strong organizational skills and ability to navigate conflict constructively