Senior Medical Director

Company Profile:

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.

Summary

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.

Responsibilities

- 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 escalate 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 and clinical presentations for health authority meetings; participate in agency interactions and support submission review activities and inspection readiness.

- Build productive relationships with investigators, key opinion leaders, external medical advisors, and internal stakeholders. Lead clinical presentations at investigator meetings and advisory boards, communicate program updates to leadership, and contribute to abstracts, manuscripts, and scientific presentations.

Required Qualifications

- Medical degree (MD or equivalent).

- At least 5 years of biotechnology or pharmaceutical industry experience in  oncology clinical development, including direct responsibility for late-phase solid tumor trials. Role level will reflect the depth and scope of relevant experience.

- Demonstrated experience in design , conduct, medical monitoring, and interpretation of Phase 3 pivotal studies, including trial delivery through key analyses and clinical study reporting.

- Hands-on experience contributing clinical content to at least one oncology marketing application (NDA or equivalent), including submission preparation and filing, with direct involvement in health authority interactions and responses to agency questions.

- Strong knowledge of Good Clinical Practice, the global drug development process, FDA and EMA requirements, and oncology efficacy and safety assessments, including RECIST, survival endpoints, and adverse event grading.

- Sound medical judgment and the ability to interpret complex data, assess benefit-risk, resolve clinical issues, and communicate clear recommendations to investigators and cross-functional teams.

- Demonstrated ability to work independently and collaboratively in a matrixed environment, manage competing priorities, and achieve clinical development milestones in a fast-paced biotechnology setting.

- Excellent interpersonal, written communication, presentation, and influencing skills, with the ability to build effective internal and external relationships.

- Ability to travel up to 2 5 % of the time.