Clinical Scientist

Arcus Biosciences is seeking a Clinical Scientist to contribute to clinical development programs, especially protocol-specific activities. The role supports study design and implementation, clinical trial execution and monitoring, data interpretation, regulatory activities, and communication with internal and external 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, safety and medical monitoring, 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 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
• Contribute to authoring of study protocols, 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
• Conduct literature reviews as needed

Benefits

• Opportunity to participate in stock programs
• A performance-based bonus
• A comprehensive benefits package
• This role can be based at our Hayward or Brisbane, CA location (preferred) or can be remote based.

Company

• Cancer biopharmaceutical company developing novel combination therapies
• Hayward, California, USA
• http://www.arcusbio.com/
• Founded in 2015
• 501-1000 employees

Qualifications

• 2+ years of experience at a pharmaceutical, CRO or biotechnology company as a clinical scientist or related role
• Master/PhD degree in health science field, PharmD, MD or non-US equivalent, or other relevant advanced degree in a health science field required
• Experience in oncology clinical trials required
• Experience with data analysis and interpretation as an understanding of safety and pharmacovigilance principles required
• Ability to think innovatively, and tactically with an interest in clinical research and drug development
• 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
• Excellent interpersonal, verbal, and written communication skills
• Ability to make independent, timely and appropriate decisions
• 2+ years of experience at a pharmaceutical, CRO or biotechnology company as a clinical scientist or related role.

Required skills

• Biostatistics, Clinical Data Analysis and Interpretation, Clinical Practice (GCP), Clinical Study Regulatory Requirements, Oncology Clinical Trials, Pharmacovigilance, Scientific Data Presentation

Experience

• 2+ years