Senior Medical Director, Clinical Development

Role Summary

Senior Medical Director, Clinical Development overseeing oncology physician leadership for palazestrant, guiding registration-enabling studies, ensuring scientific rigor and patient-centric decision-making, and contributing to biomarker development and external communications. Based in San Francisco, CA or Cambridge, MA with up to 20% travel.

Responsibilities

• Lead registration-enabling studies for palazestrant in combination with other therapies, including study design, regulatory engagement, and investigator collaboration
• Partner across functions to define and implement clinical development strategies and plans for multiple programs
• Serve as the primary medical expert and point of contact for clinical and scientific questions across internal and external stakeholders
• Represent Olema in interactions with investigators, academic collaborators, thought leaders, and regulatory authorities
• Maintain strong clinical and scientific acumen through ongoing engagement with the oncology community and key scientific meetings
• Provide medical oversight and partner with CROs for Phase 3 programs and ensure alignment with Olema’s values, SOPs, and ethical standards
• Lead the development and execution of clinical protocols, amendments, investigator brochures, study reports, abstracts, and manuscripts
• Ensure scientific rigor and data integrity in partnership with cross-functional internal teams (i.e. Clinical Operations, Biostatistics, Safety) and CRO teams
• Evaluate safety, pharmacology, and efficacy data from ongoing and completed studies to inform program strategy and decision-making
• Contribute to regulatory submissions and communications
• Collaborate with preclinical and translational scientists to develop and integrate biomarker strategies
• Support data generation, publication planning, and external communication of study results

Qualifications

• MD required
• Board certification in Oncology, Hematology/Oncology, or related specialty; significant experience in breast cancer may substitute
• A minimum of 5+ years of direct biotech or pharmaceutical experience in clinical development, with leadership in late-phase studies
• Strong understanding of breast cancer treatment paradigms; experience with ER+/HER2- disease preferred

Experience

• Proven success in designing, leading, and managing late-phase (registrational) studies in oncology; experience as a PI or academic breast cancer expert is also valued
• Deep understanding of the drug development process and ability to translate strategy into action—meeting milestones, managing budgets, and adapting to change
• Strong knowledge of GCP, FDA, and EMA/CHMP regulations; familiarity with other global regulatory standards is advantageous
• Effective leadership in a matrixed environment, influencing without authority and driving cross-functional alignment
• Exceptional communication skills—able to convey complex clinical data with clarity and purpose to both scientific and non-scientific audiences
• Demonstrated problem-solving ability with urgency, focus, and creativity
• Proven record of building collaborative, high-performing teams and partnerships
• Highly organized, detail-oriented, and adaptable to fast-paced, evolving priorities

Attributes

• Strategic, decisive, and collaborative leader who inspires confidence and trust
• Strong communicator with credibility among internal teams and external stakeholders
• Relationship builder who thrives in a dynamic, mission-driven environment
• Committed to lifelong learning and continuous professional growth