Senior Medical Director, Clinical Development

Olema Pharmaceuticals•San Francisco, CA

45d•$315,000 - $350,000•Hybrid

About The Position

As the Senior Medical Director, reporting to the SVP of Clinical Development, you 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. Partnering closely with experienced physicians and cross-functional teams, you will ensure scientific rigor, data integrity, and patient-centric decision-making while contributing to biomarker development, publication planning, and external scientific communications. This is a unique opportunity to contribute at a pivotal moment in the program's trajectory and support the advancement of therapies for patients with ER-positive, HER2-negative breast cancer. This role may be based in either San Francisco, CA or Cambridge, MA and may require up to 20% travel.

Requirements

MD required
Board certification in Oncology, Hematology/Oncology, or related specialty; significant experience in breast cancer may substitute
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 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

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