Senior Medical Director, Late Development

Role Summary

Senior Medical Director, Late Development responsible for providing medical direction, management and review of clinical trials and product development, including design of clinical development program plans, protocol development, medical monitoring, data analysis, and regulatory document preparation. May serve as Development Project Leader for a specific asset and collaborate across functions to ensure successful progress of projects and trials.

Responsibilities

• Applies disease knowledge to clinical research trial development
• Drives protocol development for clinical studies in collaboration with Clinical Operations and other clinical sub-team functions
• Drives preparation of clinical development plans in partnership with cross-functional team
• Works with Regulatory Affairs; drafts clinical scientific documents such as NDA, Investigator Brochures, Annual Reports (DSUR), and other submissions
• Contributes to CSR preparation and finalization
• Contributes to development of CRFs and data review plans
• Monitors and reviews safety and efficacy data in ongoing studies
• Serves as primary clinical point of contact for clinical trial sites
• Develops clinical abstracts and/or presents data at scientific meetings, SIVs, and conducts protocol training
• Develops and participates in advisory boards
• Acts as a clinical representative in cross-functional teams
• Serves as clinical partner to Business Development

Qualifications

• Medical degree required
• Experience in Phase 3 trial conduct, design, and execution; phase development preferred
• Thorough understanding of oncology clinical trial design (P1-P3)
• Experience and understanding of clinical trial data monitoring and all aspects of drug development
• Knowledge of GCP and ICH guidelines
• Proven self-starter and team player with strong interpersonal skills; ability to build effective relationships with colleagues and stakeholders
• Critical thinker with a solutions-oriented mindset
• Self-motivated to work in a dynamic environment
• Strong organizational and conflict-resolution abilities

Skills

• Clinical development and trial management
• Regulatory documentation and submissions
• Cross-functional collaboration and communication
• Data monitoring and analysis
• Scientific presentation and training

Education

• Medical degree

Additional Requirements

• Onsite presence required four days per week at South San Francisco headquarters