Sr. Manager, Clinical Development Scientist; Non-MD

Job Summary

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 clinical and operational excellence. The position requires effective execution of studies, close partnership with clinical and medical colleagues, clinical operations, and other functional lines.

It is accountable for timely delivery of a quality protocol, clinical execution of trials, and appropriate interpretation and communication of trial data. Maintains compliance with internal and external standards, proactively mitigates risk, and manages emerging clinical issues through timely review of clinical data, safety, and protocol deviations. The primary contact with external investigators and the internal study team for questions related to clinical aspects of the protocol, and partners with the Global Development Lead regarding study disease area strategy.

• Provide clinical input to support development of the protocol design document (PDD).
• Lead or support the development of the protocol from the approved PDD to ensure efficient protocols that maximize operational efficiency, trial quality and participant/site engagement; partner with the Global Development Lead in governance review and approval.
• Lead or support development of protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.
• Provide clinical input to the development of data collection tools; contribute to SAP, Tables, Listings and Figures (TLFs) and Bad Data Reports (BDR).
• Author and manage approval of Informed Consent Documents (ICDs) and respond to external stakeholder questions.
• Contribute to the Integrated Quality Management Plan (IQMP) and review/approve final document.
• Establish Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracting, data provision and documentation of outcomes.
• Contribute to risk management and safety plans; ensure activities align with the approved plan and collaborate with stakeholders to implement mitigations.
• Review country/site selection criteria and contribute to site training material development.
• Serve as the primary contact with external investigators and the internal study team for clinical protocol questions.
• Review and manage protocol deviations; review patient-level and cumulative data per the data review plan.
• Review safety data, SAE reports, and ensure clinical documents are updated; track and reconcile SAEs and present data during Safety Review Team meetings.
• Ensure TMF compliance for clinical documents.
• Input and review the Clinical Study Report, support safety/efficacy data disclosure, and contribute to primary publications of trial results.
• Provide clinical support to audits or inspections as needed.
• May contribute to regulatory filings (e.g., Pediatric Investigational Plan, IB, IND/NDA Annual Reports, PSURs) if required and assist with responses to regulatory queries and audit findings.
• Contribute to continuous improvement and innovative approaches to maximize trial execution effectiveness.

• BA/BS or equivalent with 6+ years of experience in biopharmaceutical clinical research and development.
• MBA or MS equivalent with 5+ years of experience; or Advanced Degree with 1+ year of experience.
• Demonstrated clinical, administrative, and project management capabilities with strong English communication skills.

• Clinical research experience in phase 3/pivotal trials preferred.
• Cardiometabolic disease experience (cardiology, obesity, endocrinology, nephrology, etc.) preferred.
• Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, adverse event management.

Candidate demonstrates breadth of leadership experiences and the ability to influence, collaborate, coach others, and guide teams to achieve outcomes and business impact.

Non-standard Work…