Director, Clinical Science
Olema Oncology
August 30, 2026
On-site
Boston, MA
Clinical Research and Development
Director, Clinical Science
Role & Responsibilities (primarily):
- Write technical/clinical documents (protocols, amendments, investigator’s brochures, and clinical sections of regulatory documents)
- Identify and track potential safety events in trials
- Partner with investigators/thought leaders to facilitate design of clinical synopses and protocols
- Evaluate safety, pharmacology, and efficacy of ongoing studies in collaboration with the medical monitor and relevant teams
- Perform study-level and subject-level analysis to support clinical study report (CSR) strategy/writing
- Contribute to/review abstracts, publications, and scientific meeting presentations
- Maintain oncology clinical and technical expertise; attend pertinent scientific meetings
Additional responsibilities:
- Collaborate with the Medical Monitor on review of 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 site visits/investigator meetings via agendas, training materials, and presentations
- Ensure adherence to SOPs and ethical standards
Qualifications:
- PhD or PharmD strongly preferred
- Oncology clinical development experience required
- Comprehensive knowledge of oncology clinical trial implementation and drug development process
- Demonstrated understanding of clinical drug development to execute strategic plans and meet milestones
Required/Preferred Skills & Experience:
- 8+ years biotech/pharma industry experience
- Strong GCP and FDA, EMEA/CHMP regulatory knowledge; other international requirements a plus
- Excellent written and oral communication; strong attention to detail
- Cross-functional collaboration; self-starter in fast-paced environment
Benefits/Compensation:
- Base pay range: $220,000–$250,000 annually; total compensation includes equity, bonus, and benefits.
Application instructions: Not specified.
Role & Responsibilities (primarily):
- Write technical/clinical documents (protocols, amendments, investigator’s brochures, and clinical sections of regulatory documents)
- Identify and track potential safety events in trials
- Partner with investigators/thought leaders to facilitate design of clinical synopses and protocols
- Evaluate safety, pharmacology, and efficacy of ongoing studies in collaboration with the medical monitor and relevant teams
- Perform study-level and subject-level analysis to support clinical study report (CSR) strategy/writing
- Contribute to/review abstracts, publications, and scientific meeting presentations
- Maintain oncology clinical and technical expertise; attend pertinent scientific meetings
Additional responsibilities:
- Collaborate with the Medical Monitor on review of 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 site visits/investigator meetings via agendas, training materials, and presentations
- Ensure adherence to SOPs and ethical standards
Qualifications:
- PhD or PharmD strongly preferred
- Oncology clinical development experience required
- Comprehensive knowledge of oncology clinical trial implementation and drug development process
- Demonstrated understanding of clinical drug development to execute strategic plans and meet milestones
Required/Preferred Skills & Experience:
- 8+ years biotech/pharma industry experience
- Strong GCP and FDA, EMEA/CHMP regulatory knowledge; other international requirements a plus
- Excellent written and oral communication; strong attention to detail
- Cross-functional collaboration; self-starter in fast-paced environment
Benefits/Compensation:
- Base pay range: $220,000–$250,000 annually; total compensation includes equity, bonus, and benefits.
Application instructions: Not specified.