Responsibilities:
- Partner with cross-functional study-level teams to conduct early clinical studies in inflammation (and potentially oncology).
- Analyze clinical trial data; gather, analyze, review, interpret, and provide preliminary assessments; communicate results to program teams.
- Perform safety/efficacy data reviews and assess protocol conduct and individual subject safety issues.
- Support senior team members with medical monitoring reports, safety reviews, site interactions, and review of TFLs.
- Support Data Monitoring Committees and other data review committees (charter operationalization, updates/data reviews, meeting execution/adjudications, synthesized report communication).
- Author and contribute to clinical documents (protocol synopses and protocols, clinical study reports, IBs, ICFs, training and other clinical/regulatory documents).
- Interact with internal/external stakeholders (sites, vendors, committees); triage questions for escalation.
- Write/review abstracts, posters, and scientific meeting/publication content; support publication strategy with investigators, KOLs, and medical affairs.
- Present at investigator meetings and site initiation visits.
- Conduct literature reviews as needed.
- Line manage junior clinical scientists.
Qualifications:
- PhD (health science), PharmD, MD (or non-US equivalent), or other relevant advanced health science degree.
- 5+ years of experience at a pharmaceutical, CRO, or biotechnology company as a clinical scientist or related role.
- Required: experience in inflammation and/or immunology clinical trials.
- Required: experience with data analysis/interpretation and safety/pharmacovigilance principles.
- Working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies.
- Ability to evaluate, interpret, and present complex scientific data to inform hypotheses and development strategy.
- Strong communication skills; ability to make independent, timely decisions; ability to work in a fast-paced matrix environment; ability to manage multiple projects with attention to detail.
Location/Application:
- Role based in Hayward or Brisbane, CA (preferred) or remote.
- Salary range: $200,000β$210,000 USD annually; stock programs, performance-based bonus, and comprehensive benefits package (as part of total rewards).