Director, Clinical Development Scientist (Non-MD)

Role Summary

The Director, Clinical Development Scientist is accountable for the scientific integrity of clinical trials, ensuring high-quality study design and operational excellence. The role leads execution of complex studies, collaborates with clinical teams, and supports interpretation and communication of trial data.

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.
• Provides clinical input to the protocol design document (PDD) and 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 Global Development Lead for governance review.
• Leads development of protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.
• Provides clinical input to 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) and approves the final document.
• Establishes Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, data provision, and documentation of outcomes.
• Reviews and approves Risk Management and Safety Review Plan; collaborates with stakeholders to mitigate risks.
• Reviews country/site selection criteria and contributes to site training materials.
• Serves as primary contact with external investigators and internal study team on clinical aspects of the protocol.
• Reviews, reports, and manages protocol deviations; reviews patient-level and cumulative data per the data review plan.
• Reviews safety data, SAE reports, TME/DME; ensures ICDs are updated; tracks and reconciles SAEs and presents data in Safety Review Team meetings.
• Ensures TMF compliance for clinical documents; inputs/ reviews the Clinical Study Report and narratives; supports disclosure of safety and efficacy data and trial conclusions; contributes to primary publication of results.
• Provides clinical support during audits/inspections; may contribute to regulatory filings and responses as needed.
• Contributes 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
• Strong clinical, administrative, and project management capabilities; excellent English communication skills
• Experience establishing, managing, and training teams in clinical development

Preferred Qualifications

• Cardiometabolic disease experience (cardiology, obesity endocrinology, nephrology, etc.)

Skills

• Leadership and collaboration across cross-functional teams
• Regulatory and compliance acumen (ICH/GCP, safety reporting)
• Protocol development, data management, and risk mitigation
• Clinical study reporting and publication support

Education

• Advanced degree or professional certification as noted in Qualifications

Additional Requirements

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