Clinical Scientist

Description

Summary

The Clinical Scientist will be an essential contributor to the scientific, clinical, and operational scope of clinical development programs with an emphasis on protocol-specific activities. The Clinical Scientist will help drive the design, planning, and implementation of study protocols for assigned investigational products and may play a key role in supporting related regulatory activities. This role will work on cross-functional study management teams for the design, execution, and monitoring of clinical trials, as well as assist with data interpretation and communication to both internal and external stakeholders. This individual may also help support internal process improvement initiatives within the clinical department.

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.

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.

This role can be based at our Hayward or Brisbane, CA location (preferred) or can be remote based. The anticipated salary range for fully qualified candidates applying for this position is $165,000 - $180,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here: https://arcusbio.com/careers.

Physical Requirements Office Setting
Must possess mobility to work in a standard office setting and use standard office equipment, including a computer; vision to read printed materials and a computer screen; and hearing and speech to communicate in person, before groups, and over the telephone. This is primarily a sedentary office classification although standing in work areas and walking between work areas may be required. Finger dexterity is needed to access, enter, and retrieve data using a computer keyboard, mouse, or calculator, and to operate standard office equipment. Positions in this classification occasionally bend, stoop, kneel, reach, push, and pull drawers open and closed to retrieve and file information. Employees must possess the ability to lift, carry, push, and pull materials and objects weighing up to 25 pounds.
#LI-Remote
#LI-JS1