Director, Clinical Science
Olema Oncology
June 27, 2026
On-site
Cambridge, MA
Clinical Research and Development
Director, Clinical Science
Responsibilities:
- Write technical/clinical documents (protocols, amendments, investigator’s brochures, and regulatory clinical sections).
- Identify/track potential safety events within trials.
- Work with investigators/thought leaders to facilitate clinical synopses and protocol design.
- Evaluate safety, pharmacology, and efficacy of ongoing studies with the medical monitor and internal teams.
- Perform study- and subject-level clinical data analysis to support CSR strategy/writing.
- Contribute to/review abstracts, publications, and presentations for scientific meetings.
- Maintain oncology clinical science expertise; attend relevant scientific meetings.
- Collaborate on enrollment packets, clinical development plans, and scientific presentations.
- Help develop informed consent forms, case report forms, and CRF instructions.
- Participate in ongoing clinical data review and support site visits/investigator meetings (agendas, training, materials).
- Ensure adherence to SOPs and ethical standards.
Qualifications:
- PhD or PharmD required.
- Oncology clinical development experience required.
- 8+ years biotech/pharma industry experience required.
- Comprehensive knowledge of oncology clinical trial implementation and drug development process.
- Demonstrated understanding of GCP and FDA/EMEA/CHMP regulations; familiarity with other international requirements a plus.
Skills/Attributes:
- Strong attention to detail; cross-functional collaboration.
- Excellent written and oral communication.
- Proactive problem-solving with urgency; teamwork leadership.
- Self-starter in fast-paced environments.
Benefits/Compensation:
- Base pay range: $220,000–$245,000 annually; total compensation includes equity, bonus, and benefits.
Location/Travel:
- San Francisco, CA or Cambridge, MA; up to 20% travel.
Responsibilities:
- Write technical/clinical documents (protocols, amendments, investigator’s brochures, and regulatory clinical sections).
- Identify/track potential safety events within trials.
- Work with investigators/thought leaders to facilitate clinical synopses and protocol design.
- Evaluate safety, pharmacology, and efficacy of ongoing studies with the medical monitor and internal teams.
- Perform study- and subject-level clinical data analysis to support CSR strategy/writing.
- Contribute to/review abstracts, publications, and presentations for scientific meetings.
- Maintain oncology clinical science expertise; attend relevant scientific meetings.
- Collaborate on enrollment packets, clinical development plans, and scientific presentations.
- Help develop informed consent forms, case report forms, and CRF instructions.
- Participate in ongoing clinical data review and support site visits/investigator meetings (agendas, training, materials).
- Ensure adherence to SOPs and ethical standards.
Qualifications:
- PhD or PharmD required.
- Oncology clinical development experience required.
- 8+ years biotech/pharma industry experience required.
- Comprehensive knowledge of oncology clinical trial implementation and drug development process.
- Demonstrated understanding of GCP and FDA/EMEA/CHMP regulations; familiarity with other international requirements a plus.
Skills/Attributes:
- Strong attention to detail; cross-functional collaboration.
- Excellent written and oral communication.
- Proactive problem-solving with urgency; teamwork leadership.
- Self-starter in fast-paced environments.
Benefits/Compensation:
- Base pay range: $220,000–$245,000 annually; total compensation includes equity, bonus, and benefits.
Location/Travel:
- San Francisco, CA or Cambridge, MA; up to 20% travel.