Associate Director, Clinical Operations

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 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,