Senior Medical Director, Late Development

Role Summary

The Senior Medical Director, Late Development, will provide medical direction, management and review of clinical trials and product development. The role includes designing clinical development program plans, clinical protocol development, medical monitoring of trials, data analysis, and preparation of trial reports and regulatory documents. The individual may serve as Development Project Leader for a specific asset and must demonstrate deep expertise in late-stage clinical drug development, with strong written and verbal communication, cross-functional influence, and adaptability in a fast-paced environment. The position is based in South San Francisco and requires onsite presence four days per week.

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 collaboratively with Regulatory Affairs; drafts clinical scientific documents such as NDAs, Investigator Brochures, Annual Reports (DSUR), and other FDA/HA 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 (eligibility questions, AE management, etc.)
• Develops clinical abstracts, 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; late development experience 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 and ability to build relationships with colleagues and stakeholders
• Critical thinker with a solutions-oriented mindset
• Self-motivated to work effectively in a dynamic environment
• Strong organizational and conflict-resolution abilities

Skills

• Excellent written and verbal communication
• Ability to influence across functions and levels
• Cross-functional collaboration and project leadership
• Data analysis and regulatory documentation preparation

Education

• Medical degree (MD) required

Additional Requirements

• Onsite requirement: four days per week at South San Francisco headquarters
• COVID-19 vaccination required (subject to reasonable accommodations for medical or religious reasons, and/or as required by applicable law)