Responsibilities:
- Partner with cross-functional study teams to drive early clinical studies in inflammation (and potentially oncology), including operational feasibility, data management deliverables, meeting materials, communication plans, safety monitoring, status reports, and study close-out.
- Analyze clinical trial data (gather, analyze, review, interpret) and provide preliminary assessments; communicate trial results to program teams.
- Perform safety/efficacy data reviews, assessing protocol conduct issues and/or individual subject safety.
- Support senior team members with medical monitoring reports, safety reviews, site interactions, and review of TFLs.
- Support Data Monitoring Committees/data review committees: operationalize charters, prepare updates/data reviews, execute meetings/adjudications, and communicate synthesized reports.
- Author/assist with clinical protocol synopses, protocols, clinical study reports, IBs, ICFs, training documents, and other clinical/regulatory documents.
- Interact with internal/external stakeholders (sites, vendors, committees); respond/triage questions for escalation.
- Write/review abstracts, posters, and scientific publication content; support publication strategy execution.
- Present at investigator meetings and site initiation visits; conduct literature reviews as needed.
- Line manage junior clinical scientists.
Qualifications & Required/Preferred Skills:
- PhD (health science), PharmD, MD (or non-US equivalent), or other relevant advanced health science degree.
- 5+ years clinical scientist (or related) experience at pharma/CRO/biotech.
- Required: inflammation and/or immunology clinical trial experience.
- Required: data analysis/interpretation with safety & pharmacovigilance principles.
- Working knowledge of biostatistics, GCP, and regulatory requirements.
- Strong ability to evaluate/interpret/present complex scientific data; excellent communication; independent, timely decision-making; manage multiple projects with attention to detail.
Benefits (if included): opportunity for stock programs, performance-based bonus, and comprehensive benefits package.