Clinical Development Expert
1 day ago
About the Role:
">This position is an opportunity to join Arcus Biosciences as a Principal Clinical Scientist and contribute to the scientific, clinical, and operational scope of clinical development programs. The successful candidate will play a key role in supporting related regulatory activities and working on cross-functional study management teams.
">Key Responsibilities:
">- Partner with cross-functional teams to conduct clinical studies, including operational feasibility, data management deliverables, preparation of meeting materials, communication plans, safety and medical monitoring, data cleaning, preparation of status update reports, and study close-out activities.
- Support senior team members with medical monitoring reports, safety reviews, site interactions, and reviewing TFLs.
- May be responsible for analytical support of clinical trial data (safety and efficacy), including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations.
- Analyze information to assess issues relating to protocol conduct and/or individual subject safety.
- Assist in communicating a clear overview of trial results.
- Provide organizational support for Data Monitoring Committees, Safety Review Committees, or other applicable data review committees including operationalizing the charter, preparing updates and data reviews, execution of meetings and adjudications, and communication of synthesized data reports.
- Author protocols and contribute to authoring of clinical study reports, IBs, ICFs, training documents, and other clinical and regulatory documents.
- Interact with internal and external stakeholders (study sites, vendors, committees, etc.) in support of clinical trial objectives; responds to or triages questions for appropriate escalations.
- Act as recognized clinical expert for assigned studies both within and external to Arcus.
- Write and/or review collaborative abstracts, posters, and content for scientific meetings, conferences and publications.
- Support publication strategy execution including collaboration with investigators, KOLs, medical affairs and other internal/external stakeholders.
- Present at investigator meetings.
- Conduct literature reviews as needed.
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