Senior Medical Director, Clinical Development

Role Summary

Senior Medical Director, reporting to the SVP of Clinical Development, will serve as the Oncology Physician Lead for palazestrant and play a pivotal role in advancing Olema’s late-stage clinical pipeline. You will guide registration-enabling studies by shaping study design, evaluating clinical data, and engaging with regulatory authorities, investigators, and key opinion leaders. You will partner with experienced physicians and cross-functional teams to ensure scientific rigor, data integrity, and patient-centric decision-making while contributing to biomarker development, publication planning, and external scientific communications. This role may be based in San Francisco, CA or Cambridge, MA and may require 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

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
• Proven success in designing, leading, and managing late-phase (registrational) studies in oncology; experience as a PI or academic breast cancer expert is 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 to 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

Skills

• Strategic, decisive, and collaborative leadership
• Strong communication and credibility with internal and external stakeholders
• Relationship-building in a dynamic, mission-driven environment
• Commitment to lifelong learning and continuous professional growth

Education

• MD required
• Board certification in Oncology, Hematology/Oncology, or related specialty

Additional Requirements

• Up to 20% travel