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 the 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 both clinical and operational excellence. The role is responsible for effective execution of studies in partnership with clinical colleagues, clinical operations, and other functional lines, ensuring timely delivery of a quality protocol and appropriate interpretation and communication of clinical trial data. It maintains compliance with internal and external standards, mitigates risk, and manages emerging clinical issues through timely data review. The primary contact with external investigators and the internal study team for clinical protocol questions, and supports the Global Development Lead regarding 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 and ensures efficient protocols 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 development of protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.
• Provides clinical input to the development of 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 reviews and approves the final document.
• Establishes Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, data provision, and documentation of outcomes.
• Contributes to Risk Management and Safety Review Plan; ensures activities align with the plan and works with stakeholders to develop risk mitigations.
• Reviews and approves country/country site selection criteria and contributes to site training materials.
• Serves as the primary contact with external investigators and internal study team 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, TMEs, DMEs, and updates clinical documents as required; tracks SAEs and presents data at Safety Review Team meetings.
• Ensures TMF compliance for clinical documents.
• Inputs and reviews the Clinical Study Report, supports disclosure of safety and efficacy data and trial conclusions, and contributes to primary publications of results.
• Provides clinical support to audits/inspections and may contribute to regulatory filings if required.
• Supports responses to regulatory queries and audit findings, and contributes to Clinical Trial Applications (CTAs).
• Contributes to continuous improvement and innovative approaches to maximize clinical trial execution effectiveness.

Qualifications

• Basic: BA/BS or equivalent with 6+ years in biopharmaceutical clinical research and development; MBA or 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; extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.

Skills

• Clinical trial design and execution
• Data management and safety monitoring
• Regulatory knowledge (ICH/GCP) and pharmacovigilance
• Stakeholder management and cross-functional collaboration
• Analytical writing and communication

Education

• BA/BS or advanced degree in a relevant field; advanced degree or MBA/MS preferred depending on years of experience

Additional Requirements

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