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 clinical trials. They apply technical and clinical skills to design efficient, high-quality trials using quantitative design principles and clinical best practices to deliver clinical and operational excellence. They ensure effective execution of studies, partnering with clinical and medical colleagues, clinical operations, and other functions to deliver timely, quality protocols and robust clinical data interpretation. They maintain compliance with standards, mitigate risk, and manage emerging issues through thorough data, safety and protocol deviation review. They serve as the primary contact with external investigators and internal study teams for clinical protocol questions and support disease area strategy with the Global Development Lead. They may provide matrix management support for IM clinicians across studies or programs.

Responsibilities

• Autonomously leads clinical execution of one or more studies of medium-high complexity with significant business impact; may be accountable for program-level clinical deliverables.
• Provide clinical input to protocol design documents and develop protocols that maximize operational efficiency, trial quality, and participant/site engagement; support governance reviews.
• Lead development of protocol amendments and related communications (Protocol Administrative Change Letters, Dear Investigator Letters).
• Provide clinical input to data collection tools and to SAPs, TLFs, and BDRs.
• Author and manage approvals of Informed Consent Documents (ICDs) and respond to external stakeholder questions.
• Contribute to the Integrated Quality Management Plan and ensure final document approval.
• Establish Data Monitoring Committees and endpoint adjudication committees, including chartering, contracts, data provision, and documentation of outcomes.
• Contribute to Risk Management and Safety Review Plan; ensure activities align with the plan and implement mitigations with stakeholders.
• Review country/site selection criteria and contribute to site training materials.
• Serve as primary contact for clinical aspects of protocol with external investigators and internal teams; manage protocol deviations.
• Review patient-level and cumulative data per the data review plan; review safety data, SAE reports, and other reports; update ICDs as required.
• Track and reconcile SAEs; lead data presentation at Safety Review Team meetings.
• Ensure TMF compliance for clinical documents; contribute to Clinical Study Reports and narratives; support safety/efficacy data disclosure and trial conclusions; contribute to primary publications.
• Provide clinical support during audits/inspections; assist with regulatory filings as needed; respond to regulatory queries and audit findings.
• Contribute to continuous improvement and innovative approaches to trial execution; may provide matrix management to clinical colleagues.

Qualifications

• Advanced degree or professional certification in a health care-related, scientific, or technical discipline required.
• 5+ years of experience in biopharmaceutical 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, with excellent verbal and written English communication.
• Experience establishing, managing, and training teams in clinical development.

Skills

• Strong leadership and cross-functional collaboration
• Clinical trial design and protocol development
• Data monitoring and safety assessment
• Regulatory awareness and documentation
• Project and vendor management

Education

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

Additional Requirements

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