Senior Medical Director, Clinical Development

Role Summary

Senior Medical Director, reporting to the SVP of Clinical Development, serving as the Oncology Physician Lead for palazestrant and playing a pivotal role in advancing Olema’s late-stage clinical pipeline. Guide registration-enabling studies by shaping study design, evaluating clinical data, and engaging with regulatory authorities, investigators, and key opinion leaders. Partner with 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. Role 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

• Required: MD
• Required: 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

Education

• MD

Skills

• Strategic, decisive, and collaborative leadership with the ability to inspire confidence and trust
• Excellent communication skills; ability to convey complex clinical data to scientific and non-scientific audiences
• Strong cross-functional collaboration and relationship-building in a matrixed environment
• Problem-solving with urgency, focus, and creativity
• Ability to translate clinical strategy into actionable plans and milestones

Additional Requirements

• Location: San Francisco, CA or Cambridge, MA
• Travel: Up to 20%