Clinical Scientist Associate Director, Late Development, Obesity

• Support late-phase clinical development by contributing to protocol development, study start-up, data review and monitoring, and analysis activities
• Working collaboratively with the study team and clinical leadership to ensure high-quality, decision-ready clinical data
• Assist in authoring clinical protocols, Investigators Brochures, and other regulatory documents ensuring consistency and clarity
• Provide input into & implementation of data management plan, CRF design, and data review oversight
• Support review, analysis, and presentation preparation of clinical trial data for internal decision making, external interactions, and regulatory submission
• Assist Development Lead and Clinical Scientist Director in medical monitoring and management of collaborators, consultants, and/or Clinical Research Organizations in completion of key projects
• Anticipate and actively manage problems across a broad spectrum of cross-functional teams
• Work cross-functionally within teams to ensure clinical strategy is translated into the development of the study concept document, study protocol, and related documents
• Support appropriate training, recruitment, and development requirements for matrix team resources

Requirements

• Doctorate degree and 3 years of clinical development experience OR Master’s degree and 5 years of clinical development experience OR Bachelor’s degree and 7 years of clinical development experience OR Associate’s degree and 12 years of clinical development experience OR High school diploma / GED and 14 years of clinical development experience
• 3 years of pharmaceutical clinical drug development experience
• Demonstrated experience contributing to clinical trial process improvements within a therapeutic area or study team environment
• Industry or academic experience supporting early or late-phase drug development within a relevant therapeutic area or disease indication
• Experience supporting the design, monitoring, and implementation of clinical trials in compliance with Good Clinical Practice standards and applicable regulatory requirements
• Working knowledge of study data readout activities, including data cleaning, database lock, data extraction, and generation of clinical data outputs
• Experience contributing to regulatory submission documents and supporting clinical regulatory responses for health authority interactions under guidance
• Experience serving as a contributing author on scientific publications or data presentations for internal forums or scientific conferences
• Experience in clinical data analysis such as Spotfire or other data analysis tools