Senior Medical Director, Late-Phase Oncology & Regulatory

Physician Pivot; Boston (MA); In loco; USD 320.000 - 350.000; Tempo pieno

Descrizione del lavoro

Verastem Oncology seeks a Medical Director/Senior Medical Director to provide medical and scientific leadership for late-phase solid tumor clinical development, focusing on the VS-7375 KRAS G12D program. Leads medical monitoring, trial design, and regulatory content for NDA/MAA submissions within a cross-functional team.

The role requires 5+ years in oncology clinical development, experience with Phase 3 pivotal studies, and collaboration with Regulatory Affairs to prepare submissions and

Competenze

• 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.
• 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 travel up to 25% of the time.

Mansioni

• 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.

Conoscenze

Late-phase oncology trials

Clinical development

Medical monitoring

Regulatory submissions

Cross-functional collaboration

Formazione

MD or equivalent

Descrizione del lavoro

Verastem Oncology seeks a Medical Director/Senior Medical Director to provide medical and scientific leadership for late-phase solid tumor clinical development, focusing on the VS-7375 KRAS G12D program. Leads medical monitoring, trial design, and regulatory content for NDA/MAA submissions within a cross-functional team.

The role requires 5+ years in oncology clinical development, experience with Phase 3 pivotal studies, and collaboration with Regulatory Affairs to prepare submissions and