Director, Clinical Science
Olema Oncology
June 27, 2026
On-site
San Francisco, CA
Clinical Research and Development
Director, Clinical Science
Role Responsibilities (primarily):
- Write technical and clinical documents including protocols, amendments, investigator’s brochures, and clinical sections of regulatory documents.
- Identify and track potential safety events within trials.
- Partner with investigators and oncology thought leaders to facilitate design of clinical synopses and protocols.
- Evaluate safety, pharmacology, and efficacy of ongoing studies with the medical monitor and safety/pharmacology/clinical operations teams.
- Perform study-level and subject-level analysis of clinical trial data to support Clinical Study Report (CSR) strategy/writing.
- Contribute to and/or review abstracts, publications, and materials for scientific meetings.
- Maintain clinical and technical expertise in oncology; attend relevant scientific meetings.
Additional responsibilities:
- Collaborate with the Medical Monitor on enrollment packets, clinical development plans, and scientific presentations.
- Work with Clinical Operations to develop Informed Consent Forms (ICFs), Case Report Forms (CRFs), and CRF instructions.
- Participate in ongoing clinical data review with cross-functional teams.
- Support development of agendas, training materials, and presentations for site visits and investigator meetings.
- Ensure adherence to SOPs and ethical standards by leading by example.
Qualifications / Requirements:
- PhD or PharmD required.
- Experience in oncology clinical development required.
- Minimum 8 years’ biotech/pharmaceutical industry experience required.
- Strong GCP knowledge and FDA and EMEA/CHMP regulations/guidelines knowledge.
Skills / Attributes:
- Knowledge of oncology clinical trial implementation and drug development process; ability to execute strategic plans and meet milestones.
- Strong attention to detail; excellent written and oral communication.
- Proactive problem-solving with urgency; effective cross-functional collaboration; self-starter.
Benefits:
- Base pay range: $220,000–$245,000 annually; total compensation includes equity and bonus, plus benefits (per summary of benefits available).
Application instructions:
- Not provided in the job posting content.
Role Responsibilities (primarily):
- Write technical and clinical documents including protocols, amendments, investigator’s brochures, and clinical sections of regulatory documents.
- Identify and track potential safety events within trials.
- Partner with investigators and oncology thought leaders to facilitate design of clinical synopses and protocols.
- Evaluate safety, pharmacology, and efficacy of ongoing studies with the medical monitor and safety/pharmacology/clinical operations teams.
- Perform study-level and subject-level analysis of clinical trial data to support Clinical Study Report (CSR) strategy/writing.
- Contribute to and/or review abstracts, publications, and materials for scientific meetings.
- Maintain clinical and technical expertise in oncology; attend relevant scientific meetings.
Additional responsibilities:
- Collaborate with the Medical Monitor on enrollment packets, clinical development plans, and scientific presentations.
- Work with Clinical Operations to develop Informed Consent Forms (ICFs), Case Report Forms (CRFs), and CRF instructions.
- Participate in ongoing clinical data review with cross-functional teams.
- Support development of agendas, training materials, and presentations for site visits and investigator meetings.
- Ensure adherence to SOPs and ethical standards by leading by example.
Qualifications / Requirements:
- PhD or PharmD required.
- Experience in oncology clinical development required.
- Minimum 8 years’ biotech/pharmaceutical industry experience required.
- Strong GCP knowledge and FDA and EMEA/CHMP regulations/guidelines knowledge.
Skills / Attributes:
- Knowledge of oncology clinical trial implementation and drug development process; ability to execute strategic plans and meet milestones.
- Strong attention to detail; excellent written and oral communication.
- Proactive problem-solving with urgency; effective cross-functional collaboration; self-starter.
Benefits:
- Base pay range: $220,000–$245,000 annually; total compensation includes equity and bonus, plus benefits (per summary of benefits available).
Application instructions:
- Not provided in the job posting content.