Executive Director, Clinical Development

Essential Job Functions and Responsibilities

• Lead the development of clinical study protocols, protocol amendments, study guides, protocol training materials, and other clinical study-related documents based on the global development plan
• Manage clinical proof of concept, pivotal studies, and regulatory submissions
• Provide practical and overarching strategic guidance for preclinical and clinical programs, ensuring that the design, implementation, and conduct of the company’s clinical studies
• Deliver unambiguous data and information that allows for clear decision-making and advancement of its developmental efforts
• Take medical responsibility in data analysis and interpretation, reporting, and communication to ensure consistency and relevance of medical content and scientific messages across Clinical Study Reports, health authority briefing books, NDA/BLA submission documents, etc.
• Identify clinical trial sites; work closely with and support Clinical Operations in site relationship activities as required
• Contribute to operational aspects of study conduct and patient enrollment efforts, including participation in site training, initiation and activation, and subsequent site engagement activities
• Maintain focus on robust study conduct and quality data generation
• Demonstrate the ability to develop unique and innovative clinical strategies to significantly shorten the development cycle in the face of an evolving regulatory landscape
• Clinical development lead for assigned development programs and represents the program to executive leadership and study team members
• Support the recruitment/screening/selection of investigators in collaboration with Clinical Operations; ensure that Good Clinical Practices (GCPs) are followed
• Author clinical reports upon completion or termination of studies
• Accountable for preparing clinical portions of protocols, investigator brochures, medical reports, efficacy and safety summaries, scientific rationales, and benefit/risk ratios
• Provide leadership in Health Authority interactions and the development of regulatory documents
• Attend and present at investigator meetings and site initiation visits as applicable
• Take initiatives with investigator and KOL engagement

Preferred Qualifications

• MD required, advanced medical or life sciences or a related area degree preferred with 12+ 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
• 10+ 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
• 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 percentage of work time, which may include overnight travel