Senior Medical Director

At Verastem Oncology, we address urgent needs of patients living with cancers driven by RAS/MAPK pathway mutations, a key driver of tumor growth and treatment resistance. FDA approval of AVMAPKI FAKZYNJA CO-PACK delivered the first therapy for women living with recurrent KRAS-mutated low-grade serous ovarian cancer, a rare cancer with significant unmet need. We’ve launched this novel/novel combination therapy in the U.S. and are exploring pathways for Europe and Japan.

We continue to advance our pipeline of drugs to help block cancer cell survival, inhibit tumor growth, and overcome treatment resistance. This is an exciting opportunity to shape the future of cancer care and make a meaningful impact in the lives of patients.

We are seeking a Medical Director/Senior Medical Director (level dependent on qualifications) to provide medical and scientific leadership for late-phase solid tumor clinical development, with a focus on the VS-7375 KRAS G12D ON/OFF inhibitor program. This individual will lead the medical aspects of assigned Phase 3 pivotal trial(s), oversee medical monitoring, and contribute directly to regulatory filing and marketing authorization activities.

The role requires demonstrated experience conducting late-phase oncology trials and preparing clinical content for regulatory submissions within a cross-functional, matrixed team.

• Lead the design and medical execution of assigned late-phase solid tumor trials in collaboration with Clinical Science, Clinical Operations, Biostatistics, Regulatory Affairs, and other study team members.

• Partner with Clinical Operations to establish study plans, timelines, resource needs, and budget inputs; monitor progress against milestones, identify risks, and resolve clinical issues affecting enrollment, trial conduct, data quality, and study completion.

• Serve as the primary medical monitor and medical contact for assigned trials. Respond to investigator inquiries, assess eligibility questions, provide consistent protocol interpretation, and guide clinical management of study participants in accordance with the protocol.

• Provide medical oversight of internal and external medical monitoring activities, including CRO support. Review emerging safety and efficacy data, clinically significant laboratory findings, and protocol deviations, and elevate issues requiring action.

• Collaborate with Pharmacovigilance on medical review of adverse events, serious adverse events, and emerging safety signals; characterize the safety profile, assess benefit-risk, and develop risk mitigation measures. Support independent data monitoring committee reviews and follow-up actions.

• Partner with Clinical Science, Data Management, Biostatistics, and Statistical Programming to conduct ongoing clinical data reviews, resolve medical queries, and support clean, complete datasets for interim analyses, database lock, and final reporting.

• Interpret and integrate efficacy, safety, pharmacology, and translational data to inform development decisions, indication expansion, and the clinical evidence supporting regulatory filings.

• Author and review protocols, amendments, investigator brochures, informed consent forms, clinical study reports, and clinical sections of regulatory submissions. Work with cross-functional teams to ensure consistency of the clinical narrative and supporting evidence.

• Directly contribute to New Drug Application (NDA) and, as applicable, Marketing Authorization Application (MAA) preparation and filing. Develop and review clinical summaries and benefit-risk assessments, and support integrated efficacy and safety analyses and responses to health authority questions.

• Partner with Regulatory Affairs to prepare briefing documents…