About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics , Inc. is the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors. Amtagvi® (lifileucel) is the first FDA-approved, one-time treatment for previously treated advanced melanoma, now approved in three global markets and available at more than 95 authorized treatment centers. The Iovance TIL platform spans registrational trials and next-generation programs in additional solid tumors, including gene-edited and IL-12 tethered TIL therapies, next-generation IL-2, and precision immuno-oncology approaches. As the first and only company to take TIL therapy from concept to a broadly accessible commercial treatment, Iovance operates as an end-to-end cell therapy company, anchored by fully owned, centralized U.S.-based manufacturing that is scaled to serve thousands of cancer patients worldwide each year. For more information, please visit www.iovance.com .
Amtagvi® and its accompanying design marks, Proleukin ® , Iovance ® , and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners.
Information on Iovance’s broad, industry-leading patent portfolio is available on the Intellectual Property page on www.iovance.com .
Overview
The Associate 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
Interfaces with Chief Medical Officer/Medical Monitor and cross-functional team members including Data Management, Drug Safety, Logistics/Manufacturing, Project Management, Regulatory Affairs, and Biostatistics
Provide direct supervision of Clinical Operations team members, including performance management and development planning
Serve as company representative at external meetings, scientific congresses, etc.
Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
Perform miscellaneous duties as assigned.
Travel
Available to travel up to 20% of the time
Required Education, Skills, and Knowledge
Bachelor’s Degree in health, or science related area
8+ years of pharmaceutical or biotech-related/clinical research experience (oncology/ immuno-oncology experience…