Remote
Director, Clinical Operations
About this role
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors.
We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer. Overview The Director, Clinical Operations will lead and manage the assigned clinical operations team and have a key role in setting and executing departmental strategy. Essential Functions and Responsibilities Oversees clinical trial agreements, budgets, expenditures and payments for clinical studies.
Ensures the timely execution of clinical research programs/protocols from conception through final clinical study report. This will generally involve close supervision of external contract organizations who will have responsibility for site interaction, site monitoring, data management, biostatistics, IRB interaction, central laboratory function, clinical research budget negotiation, medical writing, pharmacovigilance, and other critical activities.
Establishes and maintains good working relationships with clinical study site personnel to ensure adherence to protocols and Good Clinical Practice (GCP), provision of quality data and adherence to study timelines. Maintains oversight of the conduct of the studies at the study centers (site selection, start up, monitor adherence to protocols and Good Clinical Practices (GCP), applicable guidance and study closure) Key contributor to the preparation and management of clinical study protocols and protocol amendments Assists with preparation of key documents e.g.
Investigator Brochures, FDA Briefing Documents, internal or external presentations, etc. Contributes to the review of Investigator Sponsored Trials (ISTs) & the relevant documentation to support these trials. Contributes to the creation of internal Iovance Biotherapeutics SOPs & Clinical work practice documents and implementation of these plans for Clinical Operations to operate in accordance with FDA & EMA regulations.