Sr. Manager / Associate Director, Clinical Science

Sr. Manager / Associate Director, Clinical Science

Direct Hire Full-Time Role

Pay Rate: $80 - $95 per hour

Location: Redwood City, CA - Hybrid Role

Job Summary:

The Senior Director, Clinical Science, will work with the CEO/CMO to provide scientific and clinical input to early-stage clinical development programs with an emphasis on protocol-specific activities. The Senior Director, Clinical Science, collaborates on the design, planning, and implementation of study protocols. The Senior Director, Clinical Science, will review and monitor data from ongoing clinical trials, as well as assist with data interpretation and communication to both internal and external stakeholders. This role will also serve as a point of contact for CROs and investigators regarding clinical data management and interpretation.

Duties and Responsibilities:

• Manage medical monitoring plans, site interactions, and review data output from ongoing clinical studies and safety reviews.
• 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 ongoing trial results to both internal (e.g., Board of Directors) and external stakeholders.
• Provide organizational support for Data Monitoring Committees and other applicable data review committees, including operationalizing the charter, preparing updates and data reviews, executing meetings and adjudications, and communicating synthesized data reports.
• Support of clinical trial objectives; responds to or triages questions for appropriate escalation
• Act as a recognized clinical expert for assigned studies, both within and external to our company
• Contribute to the organization, preparation, and execution of investigator and advisory board meetings in collaboration with the study team and external collaborators.
• Collaborate on the preparation of scientific material for conference presentations or publications.
• The Executive Director will also provide oversight and direction within the Clinical Operations department while mentoring and developing junior department members and project team partners.

Requirements and Qualifications:

• Minimum of a bachelor's degree (PharmD/PhD, Master's, Nursing preferred) in life sciences
• 10+ years of progressively responsible clinical operations leadership experience
• Prior experience in early-stage clinical research in the biopharmaceutical industry, Phase 1/2 oncology experience preferred
• Experience in analysis and interpretation of clinical data (safety and efficacy); working knowledge of biostatistics, Good Clinical Practices, ICH, and other regulatory requirements for clinical studies
• Experience working with clinical trial sites, including global clinical research experience
• Ability to make independent, timely, and clinically appropriate decisions
• Able to communicate (written and orally) clinical and scientific data to a variety of audiences
• High level of organizational and project management skills
• Ability to handle multiple projects at a time and have a strong attention to detail while understanding the higher-level strategy

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