Senior Director, Clinical Development

Position Summary

Reporting to the Vice President, Clinical Development, the Senior Director, Clinical Development will be responsible for providing critical input into the strategy, development, management, and implementation of clinical studies by closely working across the clinical organization; leading multi-disciplinary teams charged with guiding clinical development and subsequent regulatory submissions.

Essential Job Functions and Responsibilities

• Lead the development, review and approval of clinical and regulatory documents, including protocols, investigator brochures, clinical study reports
• Provide medical and scientific oversight for assigned oncology programs, operational staff, CROs, and clinical trial sites in all areas related to the therapeutic programs
• Serve as a clinical subject matter expert for internal teams, investigators, and external stakeholders supporting the assigned solid tumor program
• Establish and approve scientific methods for design and implementation of applicable clinical protocols, data collection systems and final reports
• Provide medical and safety oversight for clinical studies, including SAE review, safety signal evaluation, and participation in safety governance activities
• Lead the analysis, interpretation, and communication of clinical data to support development, regulatory, and portfolio decision-making
• Build and maintain relationships with principal investigators and key opinion leaders to support the successful execution of clinical development programs
• Contribute clinical expertise to regulatory strategy and health authority engagements, supporting major regulatory submissions and development milestones across the product lifecycle
• Provide scientific leadership, guidance, and mentorship to cross-functional clinical teams on medical, scientific, and therapeutic area topics
• Lead the preparation and review of clinical study reports and other regulatory documents to support global submissions
• Partner cross-functionally across clinical operations, safety, biometrics, regulatory, medical writing, and medical affairs to advance programs and support key business objectives
• Serve as a therapeutic area subject matter expert, presenting clinical and scientific data to internal and external stakeholders
• Support publication strategy and the development and review of publications

Preferred Qualifications

• MD required, advanced medical or life sciences or a related area degree preferred with 10+ years of experience in the life sciences industry or an equivalent combination of academic and industry experience
• Oncology solid tumor clinical development experience is required
• 8+ years of experience in clinical development
• Proven track record of leading clinical development programs from early-phase trials through regulatory submissions
• Strategic leadership skills with the ability to inspire, mentor and manage cross-functional teams
• Demonstrated ability to excel in a fast-paced, entrepreneurial environment and effectively adjust priorities in response to changing business needs
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders
• Strong analytical and problem-solving abilities, with a strategic mindset

This position requires periodic/regular travel, including up to 15% of work time, which may include overnight travel.