Director, Clinical Science
Olema Oncology
August 30, 2026
On-site
Cambridge, MA
Clinical Research and Development
Director, Clinical Science
Responsibilities:
- Write technical and clinical documents (protocols, amendments, investigator’s brochures, and clinical sections of regulatory documents).
- Identify and track potential safety events within a trial.
- Work with investigators and oncology thought leaders to facilitate clinical synopses and protocol design.
- Evaluate safety, pharmacology, and efficacy of ongoing studies with the medical monitor and safety/pharmacology/clinical operations teams.
- Organize and perform study-level and subject-level analysis to develop strategies for Clinical Study Report (CSR) writing.
- Write and/or review product-specific abstracts/publications and support scientific meeting presentations.
- Maintain oncology clinical and technical expertise; attend relevant scientific meetings.
- Collaborate on enrollment packets, clinical development plans, and scientific presentations.
- Collaborate with Clinical Operations to develop Informed Consent Forms, Case Report Forms, and CRF instructions.
- Participate in ongoing clinical data review with cross-functional teams.
- Support development of agendas/training materials for site visits and investigator meetings.
Required/Preferred Qualifications & Skills:
- PhD or PharmD strongly preferred.
- Experience in oncology clinical development required; comprehensive knowledge of oncology clinical trial implementation and drug development process.
- Minimum 8 years’ biotech/pharmaceutical industry experience required.
- Strong knowledge of GCP and FDA/EMEA/CHMP regulations; other international regulatory familiarity is a plus.
- Excellent written and oral communication; strong attention to detail.
- Ability to work effectively in cross-functional teams; proactive problem-solving and urgency.
Compensation/Benefits (as stated):
- Base pay range: $220,000–$250,000 annually; total compensation includes equity, bonus, and benefits.
Application instructions:
- Olema doesn’t accept agency resumes.
Responsibilities:
- Write technical and clinical documents (protocols, amendments, investigator’s brochures, and clinical sections of regulatory documents).
- Identify and track potential safety events within a trial.
- Work with investigators and oncology thought leaders to facilitate clinical synopses and protocol design.
- Evaluate safety, pharmacology, and efficacy of ongoing studies with the medical monitor and safety/pharmacology/clinical operations teams.
- Organize and perform study-level and subject-level analysis to develop strategies for Clinical Study Report (CSR) writing.
- Write and/or review product-specific abstracts/publications and support scientific meeting presentations.
- Maintain oncology clinical and technical expertise; attend relevant scientific meetings.
- Collaborate on enrollment packets, clinical development plans, and scientific presentations.
- Collaborate with Clinical Operations to develop Informed Consent Forms, Case Report Forms, and CRF instructions.
- Participate in ongoing clinical data review with cross-functional teams.
- Support development of agendas/training materials for site visits and investigator meetings.
Required/Preferred Qualifications & Skills:
- PhD or PharmD strongly preferred.
- Experience in oncology clinical development required; comprehensive knowledge of oncology clinical trial implementation and drug development process.
- Minimum 8 years’ biotech/pharmaceutical industry experience required.
- Strong knowledge of GCP and FDA/EMEA/CHMP regulations; other international regulatory familiarity is a plus.
- Excellent written and oral communication; strong attention to detail.
- Ability to work effectively in cross-functional teams; proactive problem-solving and urgency.
Compensation/Benefits (as stated):
- Base pay range: $220,000–$250,000 annually; total compensation includes equity, bonus, and benefits.
Application instructions:
- Olema doesn’t accept agency resumes.