Position Description
Executive Director, Clinical Development (MD)
Location
Remote
Position Summary
The Executive Director, Clinical Development is a senior leader responsible for directing the planning, execution, and interpretation of clinical trials and related data collection activities across Phases I–IV. This role defines and approves the scientific methods used to design clinical protocols, data collection systems, and final study reports, and provides strategic clinical leadership for products under development.
Working at the intersection of science, regulation, and commercial strategy, the Executive Director ensures that clinical programs meet Company objectives, comply with regulatory standards, and advance the medical and scientific positioning of the Company's portfolio.
Key Responsibilities
Clinical Strategy & Program Leadership
• Oversee the development and management of Clinical Development Plans (CDPs), including timelines, budgets, and resource requirements.
• Ensure the development and implementation of clinical program strategy aligned with Company objectives.
• Oversee the design of pivotal clinical studies for product approval and registration.
• Drive strategy and direction across major functional areas, evaluating intangible variables and influencing policy.
Clinical Trial Execution & Oversight
• Direct the planning, execution, and interpretation of human clinical trials, Phases I–IV.
• Define and approve scientific methods for clinical protocols, data collection systems, and final reports.
• Recruit clinical investigators and negotiate study design and costs.
• Ensure adherence to protocols and determine study completion.
• Oversee and perform medical monitoring, including adverse event reporting and safety surveillance.
Regulatory & Scientific Affairs
• Prepare and coordinate clinical and scientific information for FDA submissions.
• Ensure compliance with ICH, GCP, and applicable regulatory standards (GMP/GLP knowledge preferred).
• Serve as consultant or liaison with partner organizations under licensing agreements.
External Engagement & Thought Leadership
• Act as a clinical opinion leader engaging physicians and external experts at a peer level.
• Identify and develop collaborations with external investigators and key opinion leaders.
• May create and chair the Medical Advisory Board for proprietary products.
• Drive development of publications arising from studies and related initiatives.
Cross-Functional Collaboration
• Partner closely with Clinical Research, Regulatory Affairs, Clinical Operations, Marketing, and Business Development.
• Provide clinical analysis and scientific support to expand market share of Company products.
• Guide the development of promotional materials and the training of product representatives.
• Interact with internal and external executive-level stakeholders, negotiating matters of strategic importance.
People Leadership
• Select, develop, and evaluate staff to ensure efficient operations.
• May lead internal staffing and performance management, including hiring, training, coaching, and performance reviews.
• Mentor junior staff and foster scientific and professional growth across the team.
Qualifications
Education
• MD required.
Experience
• Minimum of 15 years of relevant clinical development or medical affairs experience.
• Demonstrated extensive experience designing clinical studies.
• At least 8 years of management experience preferred.
Knowledge & Skills
• Deep understanding of clinical product development in the pharmaceutical industry and competitive strategies.
• Working knowledge of ICH and GCP required; GMP and GLP preferred.
• Strong analytical skills, including the ability to interpret scientific research and literature.
• Proven ability to solve complex problems with innovative solutions; strong organizational skills.
• Excellent written and verbal communication skills, including formal presentations to senior management and key opinion leaders.
• Self-starter and team player with strong interpersonal skills.
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Originally posted by Nektar Therapeutics. View original posting
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