Associate Director, Clinical Operations
Core
Lead and manage the clinical operations team to execute tumor infiltrating lymphocyte (TIL) cell therapy clinical research programs from conception through final report.
Role type
Senior IC clinical operations manager
Builds
Clinical research programs for solid tumor patients
Domain
Biotechnology / Oncology / Cell Therapy
Required skills
Clinical trial management, budget management, protocol development, site monitoring oversight, regulatory compliance (FDA/EMA), team leadership, cross-functional collaboration, contract organization management
Preferred skills
Oncology/immuno-oncology experience, Investigator-sponsored trial management, SOP creation, scientific congress representation
Technologies
Microsoft Office suite, CTM systems, EDC systems (eClinical, Medidata RAVE, InForm), Safety/Pharmacovigilance databases (ARGUS)
Responsibilities
Oversee clinical trial agreements, budgets, and expenditures; supervise external contract organizations; establish relationships with clinical study sites; maintain oversight of study conduct and closure; contribute to protocol and amendment preparation; create internal SOPs; provide direct supervision of team members; represent the company at external meetings.
Seniority
Senior, hands-on IC
