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Salary: USD 275,000 - 300,000 / annual
Olema Oncology is a clinical-stage biopharmaceutical company developing novel therapies for breast cancer and other oncology indications. The company's lead product candidate, palazestrant, is a complete estrogen receptor antagonist (CERAN) and selective estrogen receptor degrader (SERD) currently in two pivotal Phase 3 clinical trials for ER+/HER2- metastatic breast cancer. Top-line data from the OPERA-01 trial is expected in Q1 2027, with potential commercial launch in 2028. The company also has a follow-on candidate, OP-3136, a KAT6 inhibitor in early clinical development.
As Medical Director, Clinical Development, you will serve as the 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. Working 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.
Key responsibilities include: providing medical leadership and expertise on registration-enabling studies for palazestrant in combination therapies; partnering across functions to define and implement clinical development strategies for multiple programs; serving as the medical expert and point of contact for clinical and scientific questions; participating in interactions with investigators, academic collaborators, thought leaders, and regulatory authorities; maintaining strong clinical and scientific acumen through ongoing engagement with the oncology community; providing medical oversight and partnering with CROs for the palazestrant program; contributing to development and execution of clinical protocols, amendments, investigator brochures, study reports, abstracts, and manuscripts; ensuring scientific rigor and data integrity in partnership with internal teams and CRO teams; evaluating safety, pharmacology, and efficacy data to inform program strategy; contributing to regulatory submissions and communications; collaborating with preclinical and translational scientists on biomarker strategies; and supporting data generation, publication planning, and external communication of study results.
The role is based in Cambridge, MA and may require up to 20% travel.
REQUIREMENTS:
- MD (US Board Certified) required
- Board certification in Oncology, Hematology/Oncology, or related specialty; significant academic or industry experience required
- Minimum 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 designing and managing clinical studies in oncology; strong experience as a PI or academic breast cancer expert 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 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
- 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
- Skilled relationship builder who thrives in a dynamic, mission-driven environment
- Committed to continuous learning, professional growth, and the development of others
