Medical Director, Clinical Development

About the Role >>> Medical Director, Clinical Development 

As the Medical Director, you will serve as an Oncology Physician for palazestrant and play a pivotal role in advancing Olema’s late and early-stage clinical pipeline in breast cancer. 

You will contribute to 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 will be based in Cambridge, MA and may require up to 20% travel. 

Key Responsibilities 

Provide Medical Leadership and Expertise 

• Contribute to 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 medical expert and point of contact for clinical and scientific questions across internal and external stakeholders 
• Participate 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 the palazestrant  program and ensure alignment with Olema’s values, SOPs, and ethical standards 
• Contribute to 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 bring clinical and scientific expertise, a collaborative mindset, and a hands-on approach to execution. You are also eager to grow professionally, broaden your leadership capabilities, and expand your career by taking on increasing responsibility and helping shape the future of Olema’s clinical development programs. 

Knowledge 

• MD (US Board Certified) is required 
• Board certification in Oncology, Hematology/Oncology, or related specialty; significant academic or industry experience 
• A minimum of 2+ years of direct biotech or pharmaceutical experience in clinical development, conducting  clinical studies; strong Academic background may substitute
• Strong understanding of breast cancer treatment paradigms

Experience 

• Experience in designing and managing clinical studies in oncology; strong experience as a PI or academic breast cancer expert is also valued 
•  Thorough understanding of the drug development process and ability to translate strategy into action—meeting milestones, and adapting to change 
• Strong knowledge of GCP, FDA, and EMA/CHMP regulations; familiarity with other global regulatory standards is advantageous 
• Demonstrated ability to operate effectively in a matrixed environment, influence without direct authority, and drive cross-functional alignment
• Exceptional communication skills—able to convey complex clinical data with clarity and purpose to both scientific and non-scientific audiences, verbal and written 
• Demonstrated problem-solving ability with urgency, focus, and creativity 
• Proven record of participating in collaborative, high- performing teams and partnerships 
• Highly organized, detail-oriented, and adaptable to fast-paced, evolving priorities 

Attributes 

• Thoughtful, decisive, and collaborative leader who inspires confidence and trust
• Systems thinker who can connect complex information, anticipate downstream impacts, and translate strategy into action
• Strong communicator who builds credibility with internal teams and external stakeholders
• A skilled relationship builder who thrives in a dynamic, mission-driven environment
• Committed to continuous learning, professional growth, and the development of others 

The base pay range for this position is expected to be $275,000 - $300,000 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.

#LI-MK1