Senior Clinical Scientist

Job Title: Senior Clinical Scientist

Job Number: 35679

Location: Remote, 

Job Description

The Senior Clinical Scientist will be a contributor to the scientific, clinical, and operational scope of clinical development programs with an emphasis on protocol-specific activities.  The Senior Clinical Scientist will help drive the planning and implementation of study protocols for assigned investigational products.  This role will work on cross-functional study management teams for the execution and monitoring of clinical trials, as well as assist with data interpretation and communication to internal 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, 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 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 of clinical study reports, clinical protocols 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.
• Present at investigator meetings and scientific conferences.
• Conduct literature reviews as needed.

Required Skills

• At least 2+ years of experience at a pharmaceutical, CRO or biotechnology company as a clinical scientist or related role.
• Preferably a PhD degree in health science field, PharmD, MD or non-US equivalent;  other relevant advanced degree in a health science field.
• Experience in oncology or oncology immunotherapy clinical trials preferred.
• 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.

Working West Coast hours may be required as needed and base salary likely $175,000 – $185,000 USD annually.