We are seeking a Senior Medical Director to lead late-stage clinical development programs in Oncology, including pivotal Phase III trials and registration-enabling studies. This individual will play a key role in shaping and executing clinical strategy, serving as Medical Monitor, supporting regulatory submissions and commercialization efforts, and partnering cross-functionally to advance oncology assets successfully.
This position is based onsite in the South San Francisco, CA or Cambridge, MA area.
Key Responsibilities
Clinical Trial Leadership: Provide medical leadership for the design and execution of late-stage clinical trials, including pivotal and confirmatory studies. Partner closely with Clinical Operations to ensure studies are conducted in alignment with scientific objectives, patient safety standards, and regulatory requirements.
Medical Monitoring: Serve as Medical Monitor for Phase III and registration trials, ensuring patient safety, protocol compliance, and timely medical oversight. Review safety data, support data monitoring activities, and act as a primary medical contact for study teams and investigators.
Clinical Strategy: Contribute medical and scientific leadership to clinical development strategy, regulatory submissions, and lifecycle planning across oncology programs.
Cross-Functional Collaboration: Work closely with Regulatory Affairs, Clinical Operations, Pharmacovigilance, Biostatistics, Medical Affairs, and Commercial teams to align clinical execution with broader business objectives.
External Engagement: Represent the organization in interactions with investigators, key opinion leaders, regulatory authorities, and external collaborators.
Data Analysis & Interpretation: Analyze clinical trial data and real-world evidence to identify trends, assess efficacy and safety signals, and support data-driven decision-making. Translate findings into actionable insights that inform clinical strategy, regulatory submissions, and program advancement.
Lifecycle Management: Support strategies for label expansion, post-marketing commitments, and long-term product differentiation.
Regulatory Support: Lead preparation of regulatory documents, participate in global health authority interactions, and contribute to risk management planning throughout the development lifecycle.
Business Development Support: Provide clinical expertise for licensing opportunities, partnerships, and due diligence activities.
Stakeholder Leadership: Build strong cross-functional relationships, challenge ideas constructively, and drive decisions grounded in scientific evidence.
Scientific Leadership: Maintain a current understanding of oncology trends, the competitive landscape, and regulatory developments to inform program strategy.
Additional Requirements: Ability to work across multiple time zones and travel up to 30%.
Qualifications
Required
Preferred