Executive Director, Clinical Development Lead

Responsibilities

• Serve as the clinical lead on cross-functional development program teams to develop and execute the overall clinical development strategy for assigned programs, in collaboration with key stakeholders and leadership, while providing scientific and medical input into target product profiles, development plans, and lifecycle strategies.
• Lead the development of clinical trial design and strategies based on the scientific rationale and development and program objectives, including development of study protocols, investigator brochures, and clinical study reports.
• Partner closely with Clinical Operations to execute on clinical trials, including study execution, recruitment and enrollment, development of study specific management plans and materials, and data management activities.
• Collaborate with Program Management, Clinical Operations, Biostatistics, Data Management, Pharmacovigilance, Regulatory Affairs, and Medical Affairs to ensure high-quality study and program execution.
• Ensure internal study teams, investigators and site personnel, and external vendors are trained on clinical trial design and rationale, and provide support for data management activities, including development of case report forms, review of protocol deviations, and resolution issues.
• Support medical monitors in evaluating safety data, including review of safety reports, contribution to risk assessment and mitigation plans, and interfacing with investigators as applicable.
• Lead preparation for and serve as medical representative for Data Monitoring Committees (DMCs), Safety Review Committees (SRC), or similar safety data review boards.
• Contribute to development of regulatory submissions (e.g., IND/CTAs), participate in health authority agency interactions (e.g., FDA/EMA), and engage with thought leaders and investigators.
• Provide clinical insights to support business development, licensing, and due diligence activities.
• Drive a culture of scientific excellence, innovation, and collaboration.
• Ensure activities are executed in accordance with regulatory requirements, ICH/GCP guidance, and company standards.
• Standby to represent the company at meetings with regulatory agencies, industry partners, and other stakeholders.

Qualifications And Experience

• MD, PhD, or PharmD in a relevant life sciences discipline
• Minimum 8–12+ years of experience in clinical research and drug development within biotech/pharma
• Demonstrated experience leading clinical programs and interacting with regulatory authorities, including successful submissions of IND/CTAs
• Strong understanding of clinical trial design, including endpoint development, patient selection criteria, statistical analyses, sponsor oversight responsibilities, and regulatory requirements
• Experience across multiple phases of development
• Strategic thinking and decision-making ability
• Excellent communication and presentation skills
• Strong leadership and cross-functional collaboration capabilities
• Ability to manage multiple priorities in a fast-paced environment