Executive Director, Program and Study Management, Cardiovascular/ Atherosclerosis, Respiratory & Metabolism
$255,800–$402,700 year
HybridRahway, New Jersey, United States
Job Summary
Lead strategic planning and end-to-end delivery of HQ-sponsored and acquired-outsourced clinical trials across Cardiovascular, Respiratory, and Metabolism therapeutic areas. Translate scientific objectives into executable operational strategies while managing a $1B+ grant budget and ensuring compliance with GCP, ICH guidelines, and global regulatory requirements. Guide cross-functional teams through trial phases, monitor KPIs for enrollment, data quality, and cycle times, and leverage predictive analytics to mitigate operational risks. Provide visible leadership for global program and study management professionals, fostering talent development and driving organizational modernization through AI-enabled solutions and process innovation. Serve as the key operational partner to Clinical leadership, ensuring alignment with the development pipeline and championing industry best practices.
Required Qualifications
- Bachelor's degree with a concentration in a scientific-related discipline
- Advanced scientific degree (e.g., MS, PharmD, Ph.D.) or a combination of equivalent experience and training
- 12+ years of relevant experience working on clinical development programs (pharma/biotech/CRO) or equivalent combination of education and experience
- Extensive experience in the planning and execution of clinical trials
- Demonstrated ability to effectively manage scope, time and cost of assigned projects
- Proven ability to lead and actively contribute to the design and implementation of cross-functional strategic, process, and improvement initiatives
- Expertise in the designated TA with understanding of the specific operational challenges of the TA
- Proven experience implementing digital solutions (AI, automation and predictive analytics) to modernize clinical operations
- Strong knowledge of GCP/ICH and global regulatory expectations
- Proven history of developing talent and building robust talent pipelines
- Exceptional executive presence with the ability to break down silos, influence without direct authority, and drive alignment across complex global R&D teams
- Artificial Intelligence (AI)
- Cardiometabolic
- Cardiovascular Medicine
- Clinical Development
- Clinical Trial Planning
- Clinical Trials
- Digital Leadership
- Executive Leadership
- Global Team Collaboration
- Good Clinical Practice (GCP)
- ICH GCP Guidelines
- Key Performance Indicators (KPI)
- Matrix Leadership
- Regulatory Requirements
- Strategic Leadership
- US and Puerto Rico Residents Only
Desired Qualifications
- Concentration in a scientific-related discipline (preferred)
- Advanced scientific degree (e.g., MS, PharmD, Ph.D.) (preferred)
- Experience in the designated TA (preferred)
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