Senior Medical Director, Oncology Clinical Development

Verastem Oncology; Boston (MA); On-site; USD 260,000 - 360,000; Full time

Job summary

Verastem Oncology seeks a Medical Director/Senior Medical Director to provide medical leadership for late-stage solid tumor trials, focusing on the VS-7375 KRAS G12D program. You will lead medical aspects of Phase 3 trials, oversee monitoring, and contribute to regulatory filings.

The role demands experience in late-phase oncology trials, robust regulatory content for NDA/MAA submissions, and strong cross-functional collaboration to advance oncology programs. Travel up to 25% may be required.

Qualifications

• Medical degree (MD or equivalent).
• 5+ years biotech/pharma oncology industry experience in oncology clinical development.
• Demonstrated experience in design, conduct, medical monitoring, and interpretation of Phase 3 pivotal studies.
• Hands-on experience contributing clinical content to NDA/MAA submissions and health authority interactions.
• Strong knowledge of GCP, FDA/EMA requirements, RECIST, survival endpoints, and AE grading.
• Excellent communication, writing, and presentation skills; ability to lead cross-functional teams.
• Ability to travel up to 25%.

Responsibilities

• Lead the design and medical execution of assigned late-phase solid tumor trials in collaboration with cross-functional teams.
• Partner with Clinical Operations to plan studies, timelines, budgets, and risk management; monitor progress and data quality.
• Serve as primary medical monitor and contact for trials; guide clinical management per protocol.
• Provide medical oversight of monitoring activities, safety review, and protocol deviations.
• Collaborate on pharmacovigilance for adverse events and safety signals; support DSMC reviews.
• Contribute to ongoing data reviews and ensure clean datasets for analyses and reporting.
• Interpret integrated efficacy/safety data to inform development decisions and regulatory filings.
• Author and review clinical study documents and regulatory submissions; ensure consistent narrative.

Skills

MD or equivalent

Oncology clinical development

Phase 3 experience

NDA/MAA clinical content

GCP/regulatory knowledge

Communication/presentation

Travel readiness

Education

Medical degree (MD or equivalent)

Job description

Verastem Oncology seeks a Medical Director/Senior Medical Director to provide medical leadership for late-stage solid tumor trials, focusing on the VS-7375 KRAS G12D program. You will lead medical aspects of Phase 3 trials, oversee monitoring, and contribute to regulatory filings.

The role demands experience in late-phase oncology trials, robust regulatory content for NDA/MAA submissions, and strong cross-functional collaboration to advance oncology programs. Travel up to 25% may be required.