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Associate Director, Clinical Operations

4 days, 6 hours ago
Anywhere
Full-time
Lead
Program Manager
Project and Program Management
Apply Now
Iovance Biotherapeutics

Iovance Biotherapeutics

Iovance Biotherapeutics is a biopharmaceutical company pioneering TIL therapy to treat cancer by utilizing the patient's immune system to target cancer cells.

Pharmaceuticals
251-1K
Founded 2007
View All Jobs 6

Description

  • Lead and manage the assigned clinical operations team and contribute to departmental strategy and execution.
  • Oversee clinical trial agreements, budgets, expenditures, and payments for clinical studies.
  • Ensure timely execution of clinical research programs and protocols from conception through final clinical study report.
  • Manage and supervise external contract organizations responsible for site interaction, monitoring, data management, biostatistics, IRB interaction, central laboratory activities, budget negotiation, medical writing, and pharmacovigilance.
  • Establish and maintain relationships with clinical study site personnel to support protocol adherence, GCP compliance, data quality, and study timelines.
  • Oversee study conduct at sites, including site selection, startup, protocol/GCP adherence, and study closure.
  • Contribute to the preparation and management of clinical study protocols, protocol amendments, and key study documents.
  • Review Investigator Sponsored Trials and supporting documentation for those studies.
  • Contribute to internal SOPs and clinical work practice documents and support implementation to ensure compliance with FDA and EMA regulations.
  • Interface with the Chief Medical Officer/Medical Monitor and cross-functional teams including Data Management, Drug Safety, Logistics/Manufacturing, Project Management, Regulatory Affairs, and Biostatistics.
  • Provide direct supervision, performance management, and development planning for Clinical Operations team members.
  • Represent the company at external meetings, scientific congresses, and other external forums.

Requirements

  • Bachelor’s degree in a health- or science-related field.
  • 8+ years of pharmaceutical or biotech-related clinical research experience.
  • Oncology or immuno-oncology experience required.
  • Demonstrated experience leading Phase 1-4 studies and supporting investigator-initiated trials.
  • Proven success managing clinical studies within timeline and budget.
  • Strong managerial, interpersonal, verbal, and written communication skills.
  • Experience building relationships across internal and external functional teams.
  • Ability to assimilate information quickly, identify critical factors and risks, and implement changes as needed.
  • Experience using negotiating, influencing, and problem-solving skills to meet study timelines.
  • Ability to maintain high accountability and quality standards in deliverables.
  • Proactive, self-directed, and able to adapt in a rapidly changing environment.
  • Experience with PC operating systems and Microsoft Office, including Word, Excel, PowerPoint, Project, Publisher, Outlook, and Windows NT.
  • Exposure to CTM systems, EDC systems such as eClinical, Medidata RAVE, and InForm, and safety/pharmacovigilance databases such as ARGUS.
  • Available to travel up to 20% of the time.

Benefits

  • Remote office environment with #LI-remote flexibility.
  • Commitment to reasonable accommodations for individuals with disabilities.
  • Equal-opportunity employer with a diverse and inclusive work environment.

Interested in this position?

Apply directly on the company website

Apply Now

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