Sr Clinical Development Scientist

Overview

In this role you support late-stage oncology clinical development, collaborating with the Clinical Scientist Program Lead to drive trial execution and data analysis. You will contribute to protocol design, study documentation, data tables, and regulatory materials, aiding cross-functional teams in advancing CAR-T therapy programs. You will help anticipate obstacles and integrate published science into study development, fueling progress toward cures. This position offers exposure to regulatory filings and multi-study coordination within a mission-driven company.

Responsibilities

• Develop study concepts and protocols using clinical trial design knowledge
• Participate in protocol review and discuss design decisions
• Prepare study protocols, amendments, and Investigator meeting materials with supervision
• Contribute to CRF design, Data Management Manuals, and Data Analysis Plans with supervision
• Address investigators’ questions on scientific and procedural issues under supervision
• Assist in data listings, summary tables, study results, manuscripts, and scientific presentations
• Support preparation/review of regulatory documents
• Identify and help resolve moderately complex obstacles in trials with guidance
• Coordinate teams and provide direction when needed
• Provide clinical monitoring for one or more studies as part of larger programs
• Summarize new therapeutic areas by integrating published literature into study development
• Adhere to regulatory requirements (FDA/EMA, GCP) and Gilead SOPs

Key requirements

• PharmD or PhD in clinical research or clinical pharmacology (or MS with 6+ years; BS or RN with 8+ years)
• Relevant experience in biopharma or healthcare settings with drug development exposure
• Experience with Multiple Myeloma and/or CAR-T Therapy preferred
• Proficiency with Microsoft Office and related programs
• Fast learner with adaptability across projects
• Strong analytical and communication skills
• Understanding of drug development phases and clinical trial types
• Knowledge of FDA/EMA regulations, ICH guidelines, and GCP

• Fast learner
• Flexible and adaptable to change
• Strong communication
• Microsoft Office
• Data Management Manuals and Data Analysis Plans
• CRF design and study manual development

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