Executive Director, Program and Study Management, Ophthalmology
$255,800–$402,700 year
HybridRahway, New Jersey, United States
Job Summary
Lead strategic planning and end-to-end operational delivery for HQ-sponsored ophthalmology clinical trials, managing a $1B+ grant budget and ensuring on-time, within-budget execution across all phases. Translate scientific objectives into robust strategies while leveraging predictive analytics and AI to mitigate risks and drive continuous improvement in trial delivery. Provide visible leadership for a global team, overseeing performance management, talent development, and resource planning to foster a culture of accountability and operational excellence. Act as the primary escalation point for complex operational issues, ensuring full compliance with GCP, ICH guidelines, and global regulatory requirements while championing modernization of clinical trial processes. Serve as the key operational partner to clinical leadership, building strategic internal and external partnerships to accelerate program priorities and maintain a competitive position in the therapeutic area.
Required Qualifications
- Bachelor's degree
- Concentration in a scientific-related discipline
- Advanced scientific degree (e.g., MS, PharmD, Ph.D.)
- Combination of equivalent experience and training
- 12+ years of relevant experience working on clinical development programs (pharma/biotech/CRO)
- Equivalent combination of education and experience
- Extensive experience in the planning and execution of clinical trials
- Demonstrated ability to translate knowledge and expertise to areas at all levels within organizational sphere of influence (Therapeutic Areas, Regional Operations, Data Management, Clinical Supplies, Functional Service Providers, and Vendors etc.)
- Demonstrated ability to effectively manage scope, time and cost of assigned projects
- Business savvy
- Results oriented
- 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
- 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
- Ability to break down silos
- Ability to influence without direct authority
- Ability to drive alignment across complex global R&D teams
- Artificial Intelligence (AI)
- 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
- Ophthalmology
- Regulatory Requirements
- Strategic Leadership
- US and Puerto Rico Residents Only
Desired Qualifications
- Concentration in a scientific-related discipline strongly preferred
- Advanced scientific degree (e.g., MS, PharmD, Ph.D.) or a combination of equivalent experience and training preferred
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