Director, Clinical Operations

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, startup, 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) and the relevant documentation to support these trials.
• Contributes to the creation of internal Iovance Biotherapeutics SOPs and Clinical work practice documents and implementation of these plans for Clinical Operations to operate in accordance with FDA and 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.
• Provides direct supervision of Clinical Operations team members, including performance management and development planning.
• Serves as company representative at external meetings, scientific congresses, etc.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Performs miscellaneous duties as assigned.

Travel

• Available to travel up to 20% of the time.

Required Education, Skills, and Knowledge

• A Bachelor’s Degree in health or science-related area.
• 12 to 16 years of pharmaceutical or biotech-related/clinical research experience (oncology/immuno-oncology experience required).
• Demonstrated experience in core and technical aspects of leading phase 1-4 and supporting Investigator-initiated trials.
• Demonstrated success in managing clinical studies within timeline and budget.
• Demonstrated managerial skills and strong interpersonal and communication (verbal and written) skills in interacting with clinical monitors, investigators, and various individuals in specialized areas or internal groups to facilitate translational, clinical, and correlative research.
• Able to build strong relationships with peers and partners both within and across functional teams to engage high performance.
• Able to assimilate information quickly, grasping critical factors and risks, while implementing immediate change where/when needed.
• Proven experience in using negotiating, influencing, and problem-solving skills in order to meet study timelines.
• Able to set a high level of accountability and quality in deliverables.
• Proactive, self-directed, able to thrive and adapt in a rapidly changing environment.
• Embraces the ideas of others, promotes innovation, and manages goals to reality.
• Flexible and dynamic approach to working in a fast-paced biotechnology company; willing to perform all necessary tasks, regardless of level, to facilitate success at driving a project/program to completion.
• In-depth knowledge of PC operating systems; Microsoft Office, including MS Word, MS Excel, MS PowerPoint, MS Project, MS Publisher, MS Outlook, and MS Windows NT.
• Exposure to CTM systems, EDC systems (eClinical, Medidata RAVE, InForm) and Safety/Pharmacovigilance databases (ARGUS).

Mental

Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.