Clinical Development Scientist, Senior Manager

Job Responsibilities

• Provides clinical support for one or more studies; may be accountable for program level clinical deliverables
• May provide input to the protocol design document; contributes to development of the protocol, including protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters
• Supports the study team in internal protocol review governance submissions and interactions; supports the Global Development Lead in study and disease area strategy; may participate in protocol-related KOL and Health Authority interactions
• May develop Study Informed Consent Documents and responses to external stakeholder requests
• Provides clinical input to the development of the Statistical Analysis Plan and Tables, Listings, and Figures
• Provides clinical input to the development of the clinical data collection strategy, instruments, and data review plan; performs clinical data review; may present data to internal and external stakeholders; ensures all clinical queries are appropriately addressed in support of database lock
• Provides clinical input to the development of the Safety Review Plan and Safety Narrative Plan; reviews safety data; tracks and reconciles Serious Adverse Events; participates in clinical safety data discussion; reviews safety narratives
• Provides clinical input to the development of the Risk Management Plan; partners with key stakeholders to develop and implement risk mitigations
• Supports establishment and management of External Data Monitoring Committees and Adjudication Committees
• Contributes to site selection criteria, provides clinical input to selection of sites, and may deliver protocol training to site-facing colleagues
• Participates in investigator meeting planning and may develop and deliver protocol training
• May serve as a clinical point of contact with investigators and study team; contributes to clinical response development, delivery, documentation, and curation
• May author protocol deviation sub-categories; ensures protocol deviations are reported and appropriately managed and reconciled
• Ensures TMF compliance for clinical documents
• Provides clinical input and review of the Clinical Study Report
• Provides clinical support to disclosure of safety and efficacy data and trial conclusions; may contribute to publications
• Provides clinical support to audits and inspections
• May contribute to clinical sections of regulatory filings
• Contributes to continuous improvement / process enhancement activities
• May supervise, mentor, or develop others

Basic Qualifications

• Science degree (PhD, PharmD, or equivalent) with at least 1 year, or MA/MS with at least 5 years, or BA/BS with at least 6 years of Clinical Research experience in a similar role in the biopharmaceutical industry
• Demonstrates a breadth of diverse leadership experiences and capabilities including the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues

Preferred Qualifications

• Cardiometabolic disease experience, e.g., obesity, diabetes, endocrinology, etc.
• Clinical research experience in the biopharmaceutical industry in study design, start-up, conduct, and close-out, including regulatory submissions and inspections
• Scientific productivity via publications, posters, abstracts and/or presentations
• Knowledge of clinical development, global and regional regulation, and ICH/GCP
• Clinical and administrative capabilities; effective verbal and written communication skills
• Track record of achievement in pharmaceutical development
• Understands the complexities and recent developments in the principal disease areas
• Able to set priorities 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
• Shares wins and success; develops strong team morale and spirit
• 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

Work Location Assignment

This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week. Global travel may be required.