Director, Clinical Trials

Benefits

Qualifications

• •Experience & Skills and Work Environment
• •12+ years of progressive experience in clinical research in pharma/biotech, with demonstrated leadership across multiple programs and therapeutic areas
• •Prior experience serving as a key leader supporting organizational decision-making and strategic planning required
• •Experience with regulatory filings (NDA, BLA, MAA) and regulatory authority inspections required
• •Expert understanding of drug development from pre-IND through regulatory filing and commercialization
• •Demonstrated ability to lead enterprise-level initiatives and influence at the executive level
• •Experience designing and implementing monitoring and operational standards for global programs required
• •Willing and able to travel domestically and internationally
• •Proficiency in Microsoft Office suite and clinical systems
• •Possibility of working outside of normal scheduled hours
• •7 more items(s)

Responsibilities

• •The Director, Clinical Trials serves as a senior organizational leader and expert in clinical trial design, coordination, and execution across the company’s clinical development portfolio
• •This role drives the strategic direction of clinical operations at the program and enterprise level, integrating expertise across multiple disciplines to ensure the highest standards of quality, compliance, and efficiency
• •The Director shapes organizational objectives and serves as a recognized internal and external thought leader, influencing clinical operations strategy and capability across the organization
• •Provide executive-level strategic direction and oversight for clinical operations across multiple development programs and therapeutic areas
• •Serve as a principal advisor and subject matter expert on all aspects of clinical trial design, execution, compliance, cost, and quality
• •Define and lead the organizational vision for clinical trial management practices, including SOP development and optimizations, vendor strategies, and operational standards
• •Partner with senior leadership across Clinical, Regulatory, Medical Affairs, and other functions to align clinical operations strategy with company objectives
• •Lead the design and evaluation of clinical development programs, applying advanced knowledge of statistical principles and clinical data standards
• •Drive enterprise-level CRO strategy, including selection, governance frameworks, and performance management systems
• •Oversee portfolio-level site management, monitoring strategies, and investigator network development
• •Provide expert guidance on clinical trial registration, disclosure strategy, and regulatory filing contributions
• •Establish and maintain senior KOL and institutional relationships to support program success
• •Lead portfolio-level risk identification, escalation, and mitigation strategy
• •Drive the design and implementation of company-wide clinical operational excellence initiatives
• •Lead, develop, and mentor clinical operations leadership and staff; shape functional organizational structure and culture
• •Serve as a spokesperson for clinical operations in external settings including regulatory interactions, industry forums, and partnership discussions
• •Perform other duties as required to support company goals and clinical program success
• •Primarily desk-based, generally in an office or home office setting
• •Involves extended periods of sitting and computer use
• •Occasional travel may be required
• •17 more items(s)