Director, Clinical Development Scientist (Non-MD)

Role Summary

The Director, 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, partnering with clinical operations and other functional lines to ensure timely delivery of a quality protocol, and supporting 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 review of clinical data, safety, and protocol deviations. May serve as the primary contact with external investigators and the internal study team for questions related to clinical aspects of the protocol and may provide matrix management support across one or more clinical studies or programs.

Responsibilities

• Autonomously and independently leads clinical execution of one or more studies of medium-high complexity with significant business impact; may be accountable for program-level clinical deliverables.
• Provides clinical input to support development of the protocol design document (PDD).
• Leads development of the protocol from the approved PDD 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 development of protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.
• Provides clinical input to the development of data collection tools; contributes 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 the 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 align with the plan and implements risk mitigations with stakeholders.
• Reviews country selection, develops site selection criteria, and contributes to site training materials.
• Serves as primary contact with external investigators and internal study team for protocol-related 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 clinical documents (ICD) are updated as required.
• Tracks and reconciles SAEs across a study and leads data presentation during Safety Review Team meetings.
• Ensures TMF compliance for clinical documents.
• Inputs and reviews the Clinical Study Report, including narrative review; supports disclosure of safety and efficacy data and trial conclusions; contributes to primary publications.
• Provides clinical support during audits or inspections and may contribute to regulatory filings if required.
• Contributes to continuous improvement and process enhancements to maximize clinical trial execution.
• May provide matrix management support to clinical colleagues.

Qualifications

• Advanced degree or professional certification in a health care-related, scientific, or technical discipline required.
• 5+ years of experience in the biopharmaceutical industry in clinical research and development.
• Clinical research experience in phase 3/pivotal space.
• Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
• Demonstrated clinical, administrative, and project management capabilities; excellent verbal and written English communication skills for internal and external stakeholders.
• Experience establishing, managing, and training teams in clinical development.

Skills

• Strong leadership, collaboration, and influencing abilities; ability to coach others and oversee work across colleagues to achieve outcomes.
• Proficiency in regulatory mechanics related to clinical trials and a track record of cross-functional partnership.
• Ability to manage complex programs and multiple studies with strategic and operational impact.

Education

• Advanced degree or professional certification in a health care-related, scientific, or technical discipline.

Additional Requirements

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