Senior Medical Director, Late Development

Senior Medical Director – Clinical Development Position SummaryA 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 ResponsibilitiesClinical Strategy & Trial DevelopmentApply disease?area expertise to guide clinical research strategy and trial developmentLead protocol development in collaboration with Clinical Operations and cross?functional partnersDrive creation and refinement of clinical development plansRegulatory & Scientific DocumentationPartner 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 finalizationSupport development of case report forms (CRFs) and data review plansMedical Monitoring & Data ReviewMonitor and interpret safety and efficacy data from ongoing clinical studiesServe as the primary clinical contact for trial sites, including eligibility assessments and AE managementScientific Communication & External EngagementDevelop clinical abstracts and present data at scientific meetings, site initiation visits, and protocol trainingsParticipate in advisory boards and scientific discussionsCross?Functional LeadershipRepresent Clinical Development on internal project teamsCollaborate with Business Development as the clinical subject matter expertRequirementsMedical degree (MD or equivalent) requiredExperience in Phase 3 clinical trial design, conduct, and execution preferredStrong understanding of oncology clinical trial design across Phases 1–3Experience with clinical data monitoring and comprehensive knowledge of drug development processesFamiliarity with GCP and ICH guidelinesDemonstrated ability to build strong cross?functional relationshipsCritical thinker with a solutions?oriented mindsetSelf?motivated, adaptable, and effective in a dynamic, fast?paced environmentStrong organizational skills and ability to navigate conflict constructivelyDiscipline(s): Life SciencesDuration: 2.0Job type: Permanent