Senior Medical Director, Clinical Development

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.

Key Responsibilities

Provide Medical Leadership and Expertise

• 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

Design and Deliver High-Impact Clinical Studies

• 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

Ideal Candidate Profile: Experienced Oncology Physician Leader

You are an accomplished clinical development physician who thrives on meaningful, challenging work and is motivated by the opportunity to make a lasting impact on patients’ lives. You combine deep clinical and scientific expertise with strategic vision, collaboration, and a hands-on approach to execution.

Knowledge

• 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

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

The base pay range for this position is expected to be $315,000 - $350,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

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