Associate Director, Clinical Operations

The role

The Associate Director, Clinical Operations will lead and manage the assigned clinical operations team and set and execute departmental strategy. This role involves overseeing clinical trial agreements, budgets, and the execution of clinical research programs.

What you will do

• 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
• Supervises external contract organizations
• Establishes and maintains working relationships with clinical study site personnel
• Maintains oversight of the conduct of the studies at the study centers
• Contributes to the preparation and management of clinical study protocols and protocol amendments
• Assists with preparation of key documents like Investigator Brochures and FDA Briefing Documents
• Contributes to the review of Investigator Sponsored Trials
• Contributes to the creation of internal Iovance Biotherapeutics SOPs and Clinical work practice documents
• Provides direct supervision of Clinical Operations team members

Required qualifications

• Bachelor’s Degree in health, or science related area
• 8+ years of pharmaceutical or biotech-related/clinical research experience
• Oncology/ immuno-oncology experience required
• Experience in core and technical aspects of leading phase 1-4 and supporting Investigator-initiated trials
• Success in managing clinical studies within timeline and budget
• Managerial skills
• Interpersonal and communication skills
• 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)
• Ability to remain in a stationary position standing or sitting for prolonged periods of time
• Ability to move about inside an office and exert up to 10 pounds of force occasionally
• Visual acuity to perform activities such as preparing and analyzing data and figures, viewing a computer screen, and extensive reading

Before you apply

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About the company

Iovance Biotherapeutics, Inc. is the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors. The company operates as an end-to-end cell therapy company with centralized U.S.-based manufacturing.