Clinical Business Operations Lead

Responsibilities

• Track and communicate clinical portfolio, program, and study progress to Senior Management
• Create and update detailed dashboards and trackers
• Assess data to detect trends and outliers to direct resources efficiently
• Develop and track key performance indicators for clinical operations and vendor performance
• Support program level meetings, governance forums, and action item follow-up
• Create solutions for clinical trial scenario planning, including budget templates and enrollment forecasting
• Contribute to clinical study documents or eTMF support as needed
• Assist with inspection or audit readiness activities
• Serve as clinical representative at hypercare, S&OP, and the Iovance Clinical Platform

Requirements

• Bachelor's degree with 4+ years of pharmaceutical, biotech, clinical research, or oncology experience
• Or Master's degree with 3+ years of pharmaceutical, biotech, clinical research, or oncology experience
• Experience designing, initiating, and managing phase 1-4 clinical trials
• Experience managing CROs and clinical trial vendor selection
• Knowledge of US and Global Regulations (SOPs, ICH-GCP, FDA-CFR)

About the Company

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells.