Base: $165,000 - $185,000 usd; bonus/equity: not s...
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7+ years clinical operations experience
Independent management of expanded access programs
Phase 1-4 clinical trial execution
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Iovance Biotherapeutics is seeking a Senior Clinical Trial Manager to lead and manage clinical projects, particularly in Expanded Access Programs and post-marketing studies, in a remote capacity. The ideal candidate should have extensive clinical operations experience in the pharmaceutical or biotech sectors and be adept at managing complex programs.
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Job Summary
The Senior Clinical Trial Manager will independently lead the planning and execution of Expanded Access Programs and Phase 4 post-marketing studies for tumor infiltrating lymphocyte (TIL) therapies.
This role requires managing complex collaborations with external vendors, healthcare providers, and multiple internal teams including Commercial, Medical Affairs, and Regulatory.
The position offers a competitive annual base salary range of $165,000 to $185,000 USD for a remote role with 15% travel requirements.
Matching Summary
Match Score: 75
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Iovance Biotherapeutics is seeking a Senior Clinical Trial Manager to lead and manage clinical projects, particularly in Expanded Access Programs and post-marketing studies, in a remote capacity. The ideal candidate should have extensive clinical operations experience in the pharmaceutical or biotech sectors and be adept at managing complex programs.
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Salary
Base: $165,000 - $185,000 USD; Bonus/Equity: Not specified; Benefits: Not specified
Skills & Requirements
Must-have
7+ years clinical operations experience
Independent management of Expanded Access Programs
Phase 1-4 clinical trial execution
Knowledge of ICH-GCP and FDA-CFR regulations
Experience with EDC systems like Medidata RAVE
Sunshine Act reporting compliance
Nice-to-have
Oncology or immunotherapy background
Strong stakeholder collaboration skills
Ability to adapt in dynamic environments
Process improvement initiative leadership
Key Requirements
Bachelor's degree in health or science-related area
7+ years of pharmaceutical or biotech clinical operations experience
Demonstrated success managing ISTs and non-clinical research projects
Working knowledge of Good Clinical Practices and regulatory reporting