Sr. Manager, Clinical Development Scientist (Non-MD)

Role Summary

The Sr. Manager, Clinical Development Scientist is accountable for the scientific integrity of the study and the well-being of patients enrolled in one or more clinical trials. The role applies technical and clinical skills to design efficient, high-quality trials using quantitative design principles and clinical best practices to deliver clinical and operational excellence. The role leads effective execution of studies in partnership with clinical and medical colleagues, clinical operations, and other functions, ensuring timely delivery of a quality protocol and appropriate interpretation and communication of trial data. It maintains compliance with internal and external standards, proactively mitigates risk, and manages emerging clinical issues through diligent data, safety, and protocol deviation review. The role serves as the primary contact with external investigators and internal study teams for clinical questions and supports disease area strategy with the Global Development Lead.

Responsibilities

• Provides clinical input to support development of the protocol design document (PDD).
• Leads or supports protocol development from the approved PDD to maximize operational efficiency, trial quality, and participant/site engagement while minimizing amendments or quality issues; partners with the Global Development Lead in governance review and approval.
• Leads or supports protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.
• Provides clinical input to data collection tools and to SAP, TLFs, and BDR.
• Authors and manages approval of Informed Consent Documents (ICDs) including responses to external stakeholder questions.
• Provides clinical input to the Integrated Quality Management Plan (IQMP) and approves the final document.
• Establishes Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, data provision, and documentation of outcomes.
• Inputs to, reviews, and approves Risk Management and Safety Review Plan; collaborates with stakeholders to develop risk mitigations.
• Reviews country and site selection criteria and contributes to site training materials.
• Serves as the primary contact with external investigators and internal study teams for protocol-related questions.
• Reviews, reports, and manages protocol deviations.
• Reviews patient-level and cumulative data per the data review plan for one or more studies; reviews safety data and SAE reports, ensuring ICDs are updated as required; tracks and presents SAEs at Safety Review Team meetings.
• Ensures TMF compliance for clinical documents.
• Inputs and reviews the Clinical Study Report, including narratives; supports disclosure of safety and efficacy data and trial conclusions; contributes to primary publications of results.
• Provides clinical support during audits or inspections and may contribute to regulatory filings (Pediatric Investigational Plan, IB, IND/NDA Annual Reports, PSURs, and responses to regulatory authorities) if required; may assist with responses to regulatory queries and CTAs.
• Contributes to continuous improvement and innovative approaches to maximize trial execution effectiveness.

Qualifications

• Basic: BA/BS or equivalent with 6+ years in biopharmaceutical clinical research and development; or MBA/MS with 5+ years; Advanced Degree with 1+ year; demonstrated clinical, administrative, and project management capabilities; strong English communication skills.
• Preferred: Clinical research experience in phase 3/pivotal space; cardiometabolic disease experience (cardiology, obesity, endocrinology, nephrology, etc.); extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.

Skills

• Strong leadership, collaboration, and influence across cross-functional teams
• Clinical trial design, data interpretation, and risk management
• Technical writing and communication, with ability to support regulatory and publication activities
• Regulatory knowledge (ICH/GCP) and safety monitoring

Education

• Degrees as listed in qualifications (BA/BS, MBA/MS, or Advanced Degree) and relevant certifications as applicable

Additional Requirements

• Global travel may be required
• Hybrid work arrangement: must live within commuting distance and work on-site an average of 2.5 days per week