Sr Clinical Development Scientist

Overview

In this role you support late-stage oncology clinical development, collaborating with the Clinical Scientist Program Lead to advance program-wide activities from study design to regulatory support. You will contribute to protocol and CRF development, data analysis planning, and regulatory documentation while guiding investigators and cross-functional teams. The position offers impact through shaping trial design and ensuring compliant execution in a mission-driven cancer therapy context. You will work closely with diverse teams to translate scientific insights into robust clinical development outcomes.

Responsibilities

• Develop and refine study concepts and protocols using trial design knowledge
• Participate in protocol reviews addressing scientific and procedural aspects
• Prepare study protocols, amendments, and Investigator meeting materials with supervision
• Contribute to design of CRFs, Data Management Manuals, and Data Analysis Plans with supervision
• Address scientific questions from Investigators under supervision
• Assist in preparing/data reviews, manuscripts, and scientific presentations
• Assist/regulatory document preparation and review
• Anticipate obstacles in studies and implement solutions with guidance
• Coordinate teams and provide direction when needed
• Provide clinical monitoring for one or more clinical studies or components
• Summarize new therapeutic areas by reviewing published literature for integration into study development
• Adhere to GCP, regulatory requirements, and SOPs

Key requirements

• PharmD or PhD in clinical research or clinical pharmacology with biopharma/drug development experience
• MS with 6+ years of relevant experience
• BS or RN with 8+ years of relevant experience
• Relevant experience in Multiple Myeloma and/or CAR-T Therapy preferred
• Proficiency with Microsoft Office and related programs
• Fast learner with adaptability and strong analytical skills
• Understanding of drug development stages and clinical trial types
• Knowledge of FDA/EMA regulations, ICH guidelines, and GCP
• Strong communication and organizational skills

• fast learner
• flexible and adaptable to change
• strong communication
• clinical trial design
• protocol development
• CRF design

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