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 ensure the design of efficient and high-quality clinical trials, employing quantitative design principles and clinical best practices to deliver clinical and operational excellence. They are responsible for effective execution of studies, partnering with clinical and medical colleagues, clinical operations, and other functions to deliver timely, high-quality protocols and trial data, while maintaining compliance and proactively mitigating risk. The role serves as the primary contact with external investigators and internal study teams for questions related to clinical aspects of the protocol and partners with the Global Development Lead on study disease area strategy.

Responsibilities

• Provides clinical input to support development of the protocol design document (PDD).
• Leads or supports development of the protocol from the approved PDD, ensuring efficient protocols that maximize operational efficiency, trial quality, and participant/site engagement while minimizing amendments or quality issues; partners with the Global Development Lead in governance reviews.
• Leads or supports development of protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.
• Provides clinical input to data collection tools and to SAP, TLFs, and BDR.
• Author and manage approval of Informed Consent Documents (ICDs) including responses to external stakeholder questions.
• Provides clinical input to the Integrated Quality Management Plan (IQMP) and reviews/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; ensures activities align with the approved plan and coordinates risk mitigations with stakeholders.
• Reviews and approves country selection, develops site selection criteria, and contributes to site training materials.
• Serves as the primary contact with external investigators and internal study teams for clinical protocol questions.
• Reviews, reports, and manages protocol deviations.
• Reviews patient-level and cumulative data per the data review plan across one or more studies.
• Reviews safety data, SAE reports, TME/DME data, and ensures ICDs are updated; tracks and reconciles SAEs and presents data at Safety Review Team meetings.
• Ensures TMF compliance for clinical documents.
• Inputs and reviews the Clinical Study Report, including narrative reviews; supports disclosure of safety/efficacy data and trial conclusions; contributes to primary publications.
• Provides clinical support during audits or inspections and may contribute to regulatory filings (e.g., Pediatric Investigational Plan, IB, IND/NDA annual reports, PSURs) if required; supports responses to regulatory queries and CTAs as needed.
• Contributes to continuous improvement and innovative approaches to maximize trial execution effectiveness.

Qualifications

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

Skills

• Clinical development and trial design
• Data monitoring and safety management
• Regulatory knowledge (ICH/GCP; regulatory filings)
• Cross-functional collaboration and leadership
• Data analysis and interpretation
• Documentation and technical writing

Education

• Education requirements as listed under qualifications (BA/BS or advanced degree depending on equivalent experience).

Additional Requirements

• Non-standard Work Schedule, Travel or Environment: Global travel may be required. Hybrid role; must live within commuting distance and work on-site an average of 2.5 days per week.