Location/Travel: San Francisco, CA or Cambridge, MA office; up to 20% travel.
Responsibilities:
- Write technical and clinical documents, including protocols, amendments, investigatorsβ brochures, and clinical sections of regulatory documents
- Identify and track potential safety events within a trial
- Interact with investigators and oncology thought leaders to facilitate design of clinical synopses and protocols
- 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 clinical data analysis to support CSR writing
- Contribute to writing/review of abstracts, publications, and support development of scientific meeting presentations
- Maintain clinical and technical expertise in oncology and attend relevant scientific meetings
- Collaborate 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 a cross-functional team
- Support development of agendas, training materials, and presentations for site visits and investigator meetings
- Ensure adherence to SOPs and values; model highest ethical behavior
Qualifications:
- PhD or PharmD strongly preferred
- Required: oncology clinical development experience
- Required: 8+ years in biotech/pharmaceutical industry
- Strong GCP knowledge; FDA and EMEA/CHMP regulation familiarity
Skills/Attributes:
- Strong understanding of clinical drug development process and milestone execution
- Strong attention to detail
- Proactive problem-solving and urgency
- Excellent written/oral communication; effective cross-functional teamwork
- Ability to work in a diverse, fast-paced environment; self-starter
Compensation/Benefits: Base pay range $220,000β$250,000 annually; total compensation includes equity, bonus, and benefits.
Application Instructions: Olema does not accept agency resumes.