Director / Senior Director of Clinical Operations—Radiopharmaceutical / RPT Programs
On-siteParamus, New Jersey, United States
Job Summary
Lead global clinical operations for radiopharmaceutical and radioligand therapy programs, overseeing Phase I–IV trial execution, CRO/vendor management, and budget optimization. Direct the planning, start-up, conduct, and closeout of complex studies involving radioactive drug supply, nuclear medicine site readiness, and hot sample logistics. Manage cross-functional teams to ensure alignment with ICH-GCP, radiation safety, and regulatory requirements while driving process improvements and risk mitigation strategies. Collaborate with executive leadership, Regulatory Affairs, and CMC to deliver high-quality, inspection-ready clinical trials and support timely regulatory submissions.
Required Qualifications
- A minimum of a bachelor's degree in a relevant field
- Extensive experience (10–15 years) in clinical operations
- At least 5 years of hands-on experience in a radiopharmaceutical environment
- Previous experience in progressively responsible roles within clinical operations, such as Associate / Director of Clinical Operations or equivalent
- Extensive experience in managing and leading teams, including experience in a leadership role within clinical operations
- Strong knowledge and understanding of region-relevant clinical trial regulations, guidelines, and industry standards, including GCP and applicable local regulations
- Proven track record of successfully leading the execution of clinical trials (Phase I-IV), generating and compiling the clinical components of a regulatory submission, managing multiple programs, and ensuring adherence to timelines, budgets, and quality expectations
Desired Qualifications
- An advanced degree such as a Master's, PharmD, or Ph.D. in a relevant field
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