Executive Director, Program and Study Management, Oncology
$255,800–$402,700 year
HybridNorth Wales, Pennsylvania, United States or Rahway, New Jersey, United States
Job Summary
Lead strategic planning, oversight, and end-to-end execution of HQ-sponsored and acquired-outsourced oncology clinical trials within a $1B grant budget. Translate scientific and therapeutic area objectives into robust operational strategies while managing local registration trials and regulatory commitments. Drive cross-functional collaboration to ensure on-time, on-budget delivery against key indicators for enrollment, retention, and data quality, leveraging predictive analytics to mitigate risks. Provide visible leadership for a global team, fostering talent development, performance management, and organizational compliance with GCP and ICH guidelines. Champion operational modernization through AI and automation initiatives to enhance efficiency and quality across the clinical development portfolio.
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 and 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 with the ability to break down silos, influence without direct authority, and 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
- Oncology
- 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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