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 both clinical and operational excellence. The role is responsible for effective execution of studies and works in close partnership with other clinical and medical colleagues, clinical operations, and other functional lines, ensuring 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, diligent clinical data, safety and protocol deviation review. Serves as the primary contact with external investigators and the internal study team for questions relating to 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 to maximize operational efficiency, trial quality and participant/site engagement, and minimize 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 data collection tools. Provides 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 the Integrated Quality Management Plan (IQMP). Reviews and approves final document.
• Establishes Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes.
• Contributes to Risk Management and Safety Review Plan. Ensures activities are conducted per the plan and collaborates with key stakeholders to develop risk mitigations.
• 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 clinical protocol questions.
• Reviews, reports and manages protocol deviations. Reviews patient-level and cumulative data per the data review plan across studies.
• Reviews safety data, SAE reports, TME‚Äôs, DME‚Äôs and ensures ICDs are updated as required. Tracks and reconciles SAEs and leads data presentation 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 publication of results.
• Provides clinical support during audits or inspections, including support as needed for audit/inspection.
• May contribute to clinical sections of regulatory filings (e.g., Pediatric Investigational Plan, IB, IND/NDA Annual Reports, and Periodic Safety Update Reports) if required; may support responses to regulatory queries and CTAs.
• 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.
• Preferred: MBA or MS with 5+ years of experience; Advanced Degree with 1+ year of experience.
• Demonstrated clinical, administrative, and project management capabilities with strong English communication skills.

Skills

• Clinical development knowledge across global/regional regulation, ICH/GCP, adverse event management.
• Ability to influence and collaborate with peers, develop others, and drive meaningful outcomes.

Education

• Not specified beyond qualifications in the Basic Qualifications.

Additional Requirements

• Non-standard Work Schedule, Travel Or Environment: Global travel may be required. Hybrid role; on-site ~2.5 days per week within commuting distance.