Director, Clinical Development Scientist (Non-MD)

Role Summary

The Director, Clinical Development Scientist develops and oversees the scientific integrity of clinical trials, ensuring efficient study design, high-quality execution, and compliance with regulatory standards. This role leads clinical development activities, partners across functions, and may provide matrix management within clinical 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.
• Provide clinical input to support development of the protocol design document (PDD) and lead the protocol from the approved PDD to maximize operational efficiency, trial quality, and participant/site engagement; support governance review and approval.
• Lead development of protocol amendments and communications to investigators; contribute to data collection tool development and provide clinical input to SAP, TLFs, and BDR.
• Author and manage approval of Informed Consent Documents (ICDs) and respond to external stakeholder questions.
• Provide clinical input to the Integrated Quality Management Plan (IQMP) and approve final document; establish Data Monitoring Committees and endpoint adjudication committees.
• Contribute to risk management and safety plans; ensure activities align with the approved plan; work with stakeholders to develop mitigations.
• Review country/site selection criteria; contribute to site training materials; serve as primary clinical contact for protocol questions.
• Review, report, and manage protocol deviations; review patient-level and cumulative data per the data review plan; review safety data and ensure ICDs are updated.
• Track and reconcile SAEs; lead data presentation at Safety Review Team meetings; ensure TMF compliance for clinical documents.
• Input and review the Clinical Study Report; support safety/efficacy disclosures and primary publication of results.
• Provide clinical support for audits/inspections and contribute to regulatory filings as required; assist with responses to regulatory queries and CTAs.
• Contribute to continuous improvement and process enhancements in 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, adverse event management
• Strong clinical, administrative, and project management capabilities with excellent English verbal/written communication; experience relating to internal and external stakeholders
• Experience establishing, managing, and training teams in clinical development

Skills

• Strategic and operational leadership in clinical development
• Protocol design and protocol management
• Data management, safety monitoring, and regulatory compliance
• Cross-functional collaboration and stakeholder management
• Strong analytical, writing, and communication skills

Education

• Advanced degree or professional certification in healthcare, science, or a related field

Additional Requirements

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