Clinical Development Scientist (Director)

The Clinical Development Scientist (Director) is responsible for scientific oversight, data integrity, and quality of clinical trials in Internal Medicine.

Job Responsibilities

• Independently leads clinical execution of one or more studies; may be accountable for program level clinical deliverables
• May provide input to the protocol design document; leads development of the protocol, including protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters
• Represents the study team in internal protocol review governance submissions and interactions; partners with/supports the Global Development Lead in study and disease area strategy
• Ensures development of Study Informed Consent Documents and responses to external stakeholder requests
• Provides clinical guidance to the development of the Statistical Analysis Plan and Tables, Listings, and Figures
• Provides clinical guidance to the development of the clinical data collection strategy, instruments, and data review plan
• Provides clinical guidance to the development of the Safety Review Plan and Safety Narrative Plan
• Establishes and manages External Data Monitoring Committees and Adjudication Committees
• Develops site selection criteria, provides clinical input to selection of sites, and ensures protocol training is delivered to site-facing colleagues
• Participates in investigator meeting planning and develops and delivers protocol training
• Serves as the primary clinical point of contact with investigators and study team for questions relating to clinical aspects of the protocol
• Ensures protocol deviation sub-categories are established; ensures protocol deviations identified during clinical data review are reported
• Ensures TMF compliance for clinical documents
• Provides clinical input and review of the Clinical Study Report
• Ensures disclosure of safety and efficacy data and trial conclusions
• Provides clinical support to audits and inspections
• May contribute to clinical sections of regulatory filings
• Contributes to continuous improvement / process enhancement activities and innovative approaches to maximize effectiveness of clinical trial execution
• May have managerial responsibility for other clinical colleagues or contingent workers

Basic Qualifications

• Science degree (PhD, PharmD, or equivalent) with at least 5 years, or MA/MS with at least 7 years, or BA/BS with at least 8 years of Clinical Research experience in a similar role in the biopharmaceutical industry

Preferred Qualifications

• Cardiometabolic disease experience
• Clinical research experience in the biopharmaceutical industry in study design, start-up, conduct, and close-out
• Scientific productivity via publications, posters, abstracts and/or presentations
• Extensive knowledge of clinical development, global and regional regulation, and ICH/GCP
• Clinical, administrative, and project management capabilities; effective verbal and written communication skills
• Experience launching, managing, and training clinical development teams
• Track record of achievement in pharmaceutical development
• Understands the complexities and recent developments in the principal disease areas
• Able to set priorities and manage cross-functional teams and complex projects to deliver milestones according to budgets and priorities
• Effective leader; able to mentor/coach, delegate to, and oversee others
• Able to resolve conflicts equitably; fosters open dialogue; addresses conflicts
• Shares wins and success; defines success in terms of the whole team; develops strong team morale and spirit; creates a sense of belonging
• Takes personal responsibility for delivery of results
• Able to demonstrate perspective and poise in uncertainty and organizational change
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot
• Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices