Medical Director, Clinical Development

Olema Oncology; Boston (MA); On-site; USD 275,000 - 300,000; Full time

Job summary

Olema Oncology, based in Cambridge, MA, seeks a Medical Director, Clinical Development to advance palazestrant and related programs in breast cancer. The role emphasizes regulatory engagement, study design, and cross-functional leadership across oncology teams.

You will shape registration-enabling studies, collaborate with thought leaders, and ensure scientific rigor while driving biomarker strategies and publication planning. This is a high-impact leadership role in a fast-growing company.

Qualifications

• MD (US Board Certified) is required.
• Board certification in Oncology or Hematology/Oncology; significant academic or industry experience.
• Minimum of 2+ years of biotech/pharmaceutical experience in clinical development, conducting clinical studies.
• Strong understanding of breast cancer treatment paradigms.

Responsibilities

• Lead registration-enabling studies for palazestrant with study design, regulatory engagement, and investigator collaboration.
• Define clinical development strategies and plans for multiple programs with cross-functional teams.
• Serve as the medical expert and point of contact for clinical and scientific questions across internal and external stakeholders.
• Interact 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.

Skills

Clinical development leadership

Designing oncology studies

Regulatory engagement

Cross-functional collaboration

Scientific communication

Education

MD (US Board Certified)

Board certification in Oncology

Job description

Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond. With our transformation into a fully integrated oncology company well underway, it’s an exciting time to be part of Team Olema.

Our lead product candidate, palazestrant, is a novel, orally available complete estrogen receptor antagonist (CERAN) and selective estrogen receptor degrader (SERD) currently in two pivotal Phase 3 clinical trials. We expect top-line data from OPERA-01, our ongoing Phase 3 trial of palazestrant as a monotherapy in patients with second- or third-line ER+/HER2- metastatic breast cancer (MBC), in Q1 2027 which, if positive, could lead to our first potential approval and commercial launch in 2028. OPERA-02, our Phase 3 trial of palazestrant in combination with ribociblib in patients with frontline ER+/HER2- MBC, is enrolling patients. Together with its mechanism of action, pharmacokinetic properties, and the potential to demonstrate activity in both ESR1 wild-type and mutant tumors, palazestrant could transform the metastatic breast cancer treatment paradigm and provide access to a $15 billion global market opportunity.

Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with the potential to generate further value and meaningfully impact the metastatic breast cancer treatment landscape – particularly in combination with palazestrant. We recently presented encouraging Phase 1 monotherapy data from this program across multiple solid tumor types, are advancing patient enrollment in the ongoing combination arms in MBC, and expect to initiate a Phase 1 study of OP-3136 in combination with Bayer’s darolutamide in metastatic castration-resistant prostate cancer by the end of this year.

Aspiring to transform the metastatic treatment paradigm is an ambitious endeavor that requires a resolute approach to developing better therapies and passionate colleagues dedicated to helping the patients we serve feel better, longer. Team Olema possesses a deep commitment to a shared purpose, the sustained pursuit of excellence, cultivating the courage required to advance our programs, the drive to succeed, and a collective capacity for adaptability through learning, growth, and evolution. We are a small group of nimble self-starters who bring consistency in our quest for the extraordinary every single day.

If you’re ready to be part of a tenacious, courageous, agile, and growing team, join us in making a profound impact, together – for our patients, for your career, and for what’s beyond.

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

• 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+ yearsof 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-$300,000annually, 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.

We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated.

We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants.