Responsibilities:
- Write technical/clinical documents (protocols, amendments, investigatorโs brochures, regulatory clinical sections).
- Identify and track potential safety events with the study team.
- Interact with oncology investigators/thought leaders to support protocol and clinical synopsis design.
- Evaluate safety, pharmacology, and efficacy of ongoing studies with the medical monitor, safety/pharmacology, and clinical operations teams.
- Perform study-level and subject-level clinical data analysis to inform CSR (clinical study report) strategy.
- Write/review abstracts and publications; support scientific meeting presentation development.
- Maintain oncology clinical science expertise and attend relevant scientific meetings.
- Collaborate on enrollment packets, clinical development plans, and scientific presentations.
- Work with Clinical Operations to develop Informed Consent Forms, Case Report Forms, and CRF instructions.
- Participate in ongoing clinical data review and cross-functional site/investigator meeting preparation (agendas, training materials, visit presentations).
Qualifications/Requirements:
- PhD or PharmD required.
- Experience in oncology clinical development required.
- Minimum 8 years in biotech/pharmaceutical industry required.
- Comprehensive oncology clinical trial implementation and drug development process knowledge.
- Demonstrated understanding to execute strategic plans and meet milestones.
- Strong GCP and FDA; EMEA/CHMP knowledge (other international regulatory knowledge a plus).
Skills/Attributes:
- Strong attention to detail; cross-functional collaboration.
- Excellent written and oral communication.
- Ability to work in a fast-paced, diverse environment; proactive problem-solving.
Compensation/Benefits:
- Base pay range: $220,000โ$245,000 annually; total compensation includes equity, bonus, and benefits.
Location/Travel:
- San Francisco, CA or Cambridge, MA; up to 20% travel.