Director, Clinical Development Scientist (Non-MD)

Role Summary

The Director, Clinical Development Scientist is responsible for ensuring the scientific integrity of clinical trials and the well-being of enrolled patients. The role applies technical and clinical skills to design efficient, high-quality trials, employing quantitative design principles and clinical best practices to deliver clinical and operational excellence. It includes driving effective study execution, partnering with clinical and medical colleagues, operations, and other functions, and delivering timely, high-quality protocols and data interpretation. The role may also provide matrix management support across one or more clinical studies or programs and serves as the primary contact for external investigators and internal study teams on clinical protocol matters.

Responsibilities

• Autonomously leads clinical execution of studies of medium to high complexity with significant business impact; may be accountable for program-level clinical deliverables.
• Provide clinical input to protocol design documents and lead development of protocols to maximize operational efficiency, trial quality, and site engagement while minimizing amendments or quality issues.
• Lead protocol amendments, administrative letters, and Dear Investigator Letters; contribute to data collection tool development and provide clinical input to SAP, TLFs, and BDR.
• Author and manage approval of informed consent documents and respond to external stakeholder questions.
• Develop and approve the Integrated Quality Management Plan; establish Data Monitoring Committees and endpoint adjudication committees, including chartering and data provision.
• Input to, review, and approve Risk Management and Safety Review Plans; collaborate with stakeholders to implement risk mitigations.
• Review country/site selection and contribute to site training materials; act as primary contact for protocol-related clinical questions.
• Review protocol deviations, patient-level and cumulative data, and safety data; track and present SAEs in Safety Review Team meetings; ensure TMF compliance.
• Contribute to the Clinical Study Report and narratives; support safety/efficacy data disclosure and primary publication of trial results.
• Provide clinical support during audits or inspections; may contribute to regulatory filings and responses to regulatory queries.
• Contribute to continuous improvement and innovative approaches to clinical trial execution; may provide matrix management support to colleagues.

Qualifications

• Required: 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 with a track record of success.
• Required: Clinical research experience in phase 3/pivotal space.
• Required: Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, and adverse event management.
• Required: Demonstrated clinical, administrative, and project management capabilities with excellent English verbal and written communication skills; experience relating to internal and external stakeholders.
• Required: Demonstrated experience establishing, managing, and training teams in clinical development.
• Preferred: Cardiometabolic disease experience (e.g., cardiology, obesity endocrinology, nephrology, etc.).

Additional Requirements

• Global travel may be required.
• Work location: hybrid role; must live within commuting distance and work on-site about 2.5 days per week.