Director, Clinical Science
Olema Oncology
August 09, 2026
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Director, Clinical Science
Responsibilities:
- Write technical and clinical documents including protocols, amendments, investigator’s brochures, and clinical sections of regulatory documents.
- Identify and track potential safety events within a trial.
- Facilitate design of clinical synopses and protocols with investigators and oncology thought leaders.
- Evaluate safety, pharmacology, and efficacy of ongoing studies in collaboration with the medical monitor and clinical teams.
- Perform study-level and subject-level analysis of clinical trial data to inform CSR (clinical study report) writing.
- Contribute to or review product abstracts, publications, and presentation materials for scientific meetings.
- Maintain clinical/technical expertise in oncology; attend relevant scientific meetings.
- Collaborate with the Medical Monitor on review of enrollment packets, clinical development plans, and presentations.
- Collaborate to develop Informed Consent Forms, Case Report Forms, and CRF instructions.
- Participate in ongoing clinical data review with cross-functional teams.
- Support agendas, training materials, and site visit/investigator meeting presentations.
- Ensure adherence to Standard Operating Procedures and uphold ethical behavior.
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 strategy and meet milestones.
- Minimum 8 years’ biotech/pharmaceutical industry experience required.
- Strong knowledge of GCP and FDA/EMEA/CHMP regulations; other international requirements a plus.
- Ability to proactively identify issues and propose solutions with urgency.
- Demonstrated success motivating internal/external collaborators and teamwork.
Skills/Attributes:
- Strong attention to detail.
- Effective cross-functional team interaction.
- Excellent written and oral communication.
- Ability to work in diverse, dynamic teams; self-starter in fast-paced environment.
- Passion for drug development.
Compensation/Benefits:
- Base pay range: $220,000 - $250,000 annually (plus equity, bonus, and benefits).
Application instructions:
- No agency resumes accepted.
Responsibilities:
- Write technical and clinical documents including protocols, amendments, investigator’s brochures, and clinical sections of regulatory documents.
- Identify and track potential safety events within a trial.
- Facilitate design of clinical synopses and protocols with investigators and oncology thought leaders.
- Evaluate safety, pharmacology, and efficacy of ongoing studies in collaboration with the medical monitor and clinical teams.
- Perform study-level and subject-level analysis of clinical trial data to inform CSR (clinical study report) writing.
- Contribute to or review product abstracts, publications, and presentation materials for scientific meetings.
- Maintain clinical/technical expertise in oncology; attend relevant scientific meetings.
- Collaborate with the Medical Monitor on review of enrollment packets, clinical development plans, and presentations.
- Collaborate to develop Informed Consent Forms, Case Report Forms, and CRF instructions.
- Participate in ongoing clinical data review with cross-functional teams.
- Support agendas, training materials, and site visit/investigator meeting presentations.
- Ensure adherence to Standard Operating Procedures and uphold ethical behavior.
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 strategy and meet milestones.
- Minimum 8 years’ biotech/pharmaceutical industry experience required.
- Strong knowledge of GCP and FDA/EMEA/CHMP regulations; other international requirements a plus.
- Ability to proactively identify issues and propose solutions with urgency.
- Demonstrated success motivating internal/external collaborators and teamwork.
Skills/Attributes:
- Strong attention to detail.
- Effective cross-functional team interaction.
- Excellent written and oral communication.
- Ability to work in diverse, dynamic teams; self-starter in fast-paced environment.
- Passion for drug development.
Compensation/Benefits:
- Base pay range: $220,000 - $250,000 annually (plus equity, bonus, and benefits).
Application instructions:
- No agency resumes accepted.