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. The role is responsible for effective execution of studies, partnering with clinical and medical colleagues, clinical operations, and other functional lines to ensure timely delivery of a quality protocol and data interpretation. It maintains compliance with internal and external standards, proactively mitigates risk, and manages emerging clinical issues through clinical data, safety, and protocol deviation review. The primary contact with external investigators and internal study teams handles clinical aspects of the protocol and partners with the Global Development Lead regarding 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/supports the Global Development Lead in governance review and approval process.
• 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. Responsible for providing clinical input to SAP, TLFs and BDR.
• Authors and manages approval of Informed Consent Documents (ICDs) including responses to external stakeholder questions.
• Provides clinical input to development of the Integrated Quality Management Plan (IQMP). Review and approves final document.
• Establishes Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes.
• Inputs to, reviews and approves Risk Management and Safety Review Plan. Ensures activities are conducted consistent with the approved plan and develops risk mitigations with key 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 team for questions relating to clinical aspects of protocol.
• 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‚Äôs, DME‚Äôs and ensures clinical documents (ICD) are updated as required. Tracks and reconciles SAEs and leads data presentation during 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 publication of results.
• Provides clinical support during audits or inspections and may support regulatory filings 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. MBA or MS equivalent with 5+ years, or Advanced Degree with 1+ year of experience.
• Demonstrated clinical, administrative, and project management capabilities with strong verbal and written English communication skills.

Preferred Qualifications

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

Skills

• Leadership and collaboration across peers; ability to influence and coach others; guide work to achieve outcomes.

Education

• Not specified beyond qualifications listed above; advanced degrees as noted in Basic Qualifications.

Additional Requirements

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