Senior Medical Director, Clinical Development

Role Summary

Senior Medical Director, Clinical Development, reporting to the SVP of Clinical Development, serving as the Oncology Physician Lead for palazestrant and driving advancement of Olema’s late-stage clinical pipeline. Responsibilities include guiding registration-enabling studies, shaping study design, evaluating clinical data, and engaging with regulatory authorities, investigators, and key opinion leaders. Role may be 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 (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

• Required: MD; Board certification in Oncology, Hematology/Oncology, or related specialty; significant experience in breast cancer may substitute
• Required: Minimum of 5+ years of direct biotech or pharmaceutical experience in clinical development, with leadership in late-phase studies
• Required: Strong understanding of breast cancer treatment paradigms; experience with ER+/HER2- disease preferred
• Preferred: Proven success in designing, leading, and managing late-phase (registrational) studies in oncology; experience as a PI or academic breast cancer expert
• Preferred: Deep understanding of the drug development process and ability to translate strategy into action—meeting milestones, managing budgets, and adapting to change
• Preferred: Strong knowledge of GCP, FDA, and EMA/CHMP regulations; familiarity with other global regulatory standards is advantageous
• Preferred: Effective leadership in a matrixed environment, influencing without authority and driving cross-functional alignment
• Preferred: Exceptional communication skills—able to convey complex clinical data with clarity to scientific and non-scientific audiences
• Preferred: Demonstrated problem-solving ability with urgency, focus, and creativity
• Preferred: Proven record of building collaborative, high-performing teams and partnerships
• Preferred: Highly organized, detail-oriented, and adaptable to fast-paced, evolving priorities

Skills

• Strategic, decisive, and collaborative leadership
• Superior written and verbal communication across scientific and non-scientific audiences
• Cross-functional collaboration and relationship-building in a matrix environment
• Deep oncology domain expertise, especially in ER+/HER2- breast cancer
• Regulatory knowledge and ability to contribute to submissions and communications

Education

• MD required

Additional Requirements

• Role location: San Francisco, CA or Cambridge, MA
• Up to 20% travel