Contractor - Principal Clinical Scientist (Office or Remote)

Description

J ob Title: Principal Clinical Scientist (Contractor)

Location: (Brisbane, CA or Remote)

To applicants: The current position mandates 5-10 + years experience in the clinical scientist role with a pharmaceutical, biotechnology or CRO . Applications failing to meet this specific requirement will not be considered. Please refer to the Qualifications section for additional requirements.

Job Summary

The Principal 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 Principal Clinical Scientist will work on cross-functional study management teams and contribute to the design, planning, and implementation of study protocols for assigned investigational products. Importantly, the Principal Clinical Scientist will help lead data cleaning and monitoring activities of assigned study protocols of behalf of the Clinical Science function.

Responsibilities

• Responsible for data monitoring and cleaning of clinical/medical relevant data points.
• Partner with cross-functional teams with potential 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 provide 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.
• May 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.
• 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.
• Support the development of 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.
• Support investigator meetings and scientific conferences.
• Conduct literature reviews as needed.
  
  

Education/Experience

Qualifications (including knowledge & skills):

• At least 5-10 + years of experience at a pharmaceutical, CRO or biotechnology company in a clinical scientist role. Applicants failing to meet this specific requirement will not be considered.
• Master/PhD degree in health science field, PharmD, MD or non-US equivalent, or other relevant advanced degree in a health science field.
• Experience in oncology or oncology immunotherapy clinical trials preferred.
• Significant experience with electronic data capture databases (preferably RAVE), data analysis tools ( eg , Spotfire) and data cleaning methodology.
  
  

Professional And Personal Requirements

• Ability to think strategically, 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 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.