Note: The job is a remote job and is open to candidates in USA. Arcus Biosciences is seeking a Senior Clinical Scientist to contribute to the scientific, clinical, and operational scope of clinical development programs with an emphasis on protocol-specific activities. The role involves planning and implementing study protocols, working on cross-functional teams for clinical trial execution, and assisting with data interpretation and communication to stakeholders.
Responsibilities
- Partner with cross-functional teams with oversight from senior team members to conduct clinical studies, including operational feasibility, data management deliverables, preparation of meeting materials, communication plans, 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
- Analyze and clean clinical trial data, including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments
- Provide organizational support for Data Monitoring Committees and 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
- Analyze information to assess issues relating to protocol conduct and/or individual subject safety
- Contribute to authoring clinical study reports, clinical protocols, informed consent forms, 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
- Write and/or review collaborative abstracts, posters, and content for scientific meetings, conferences and publications
- Conduct literature reviews as needed
Skills
- 3+ years of experience at a pharmaceutical, CRO or biotechnology company as a clinical scientist or related role
- Experience in oncology or oncology immunotherapy clinical trials required
- Experience with data analysis and interpretation as an understanding of safety and pharmacovigilance principles required
- Demonstrated ability to evaluate, interpret and present complex scientific data (preclinical, clinical, translational) to inform scientific hypotheses and development strategy
- Working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies
- Must be willing and possess the expertise to work effectively in a fast-paced, team-based matrix environment as well as the ability to function independently as appropriate
- Flexible to accommodate changes in team and project needs
- Ability to handle multiple projects at a time and have a strong attention to detail while understanding the higher-level strategy
- Excellent interpersonal, verbal, and written communication skills
- Ability to make independent, timely and appropriate decisions
- Preferably a PhD degree in health science field, PharmD, MD or non-US equivalent; other relevant advanced degree in a health science field
Benefits
- The opportunity to participate in stock programs
- A performance-based bonus
- A comprehensive benefits package
Company Overview
Company H1B Sponsorship