Iovance Biotherapeutics, Inc.

Compliance

• Lead one or more drug development programs, focusing on US and global (Ex-US) regulatory strategy, regulatory submissions, and interactions with global regulatory authorities
• Collaborate with functional leaders to create and negotiate optimal development paths for Iovance product candidates
• Execute clinical-regulatory development plans on time while managing identified risks
• Plan, manage, and create Clinical Trial Applications, Market Applications, and amendments
• Ensure submission documents and correspondence meet high standards for content, organization, clarity, and accuracy
• Lead cross-functional teams in developing strategic briefing packages and preparing for health authority meetings and interactions
• Incorporate evolving global regulations, guidelines, and health authority expectations for biologics and ATMPs, including cell therapy products, into program decisions
• Work within the department and with other functional areas on process improvements
• Adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics
• Perform miscellaneous duties as assigned

Associate Director – Regulatory Affairs

Manager

• Design, develop, and implement clinical supplies strategies for clinical trials
• Oversee labeling, packaging, release, distribution, and returns of clinical supplies at external CMOs
• Maintain budgets and ensure projects are delivered on time
• Create and manage clinical forecast plans and budgets for multiple programs and study levels
• Create global supply strategies and plans for clinical studies
• Collaborate with Clinical Operations, Regulatory Affairs, Quality Assurance, and external vendors
• Support new site onboarding and manage forecasting and distribution of co-therapy drugs in the US and ex-US
• Manage clinical trial supply, IMP production, inventory, and worldwide distribution to ensure uninterrupted supply
• Manage label development from master label text through printing
• Implement scheduling software for clinical trials and future commercial requirements, including chain of custody, identification, real-time scheduling, and tracking
• Manage development, review, and User Acceptance Testing of the Interactive Response Technology system
• Review manuals and documents with the Clinical Operations team
• Represent Supply Planning at clinical trial team meetings and communicate plans and timelines
• Partner with CMC, Regulatory Affairs, Clinical Operations, and Quality Assurance leaders
• Present recommendations to Senior Tech Ops, Clinical, and Commercial leadership
• Perform other duties as assigned

Senior Manager, Supply Planning

Clinical Operations

• Lead and manage the assigned clinical operations team and contribute to departmental strategy
• Oversee clinical trial agreements, budgets, expenditures, and payments
• Ensure timely execution of clinical research programs and protocols from conception through final clinical study report
• Supervise external contract organizations responsible for site interaction, monitoring, data management, biostatistics, IRB interaction, central laboratory functions, budget negotiation, medical writing, and pharmacovigilance
• Establish relationships with clinical study site personnel and ensure protocol, Good Clinical Practice, data-quality, and timeline adherence
• Oversee study conduct at centers, including site selection, start-up, monitoring, protocol/GCP adherence, applicable guidance, and study closure
• Contribute to clinical study protocols and protocol amendments
• Assist with Investigator Brochures, FDA Briefing Documents, and internal or external presentations
• Review Investigator Sponsored Trials and supporting documentation
• Contribute to Iovance SOPs and Clinical work practice documents and implement plans aligned 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
• Directly supervise Clinical Operations team members, including performance management and development planning
• Represent the company at external meetings and scientific congresses
• Adhere to company values, policies, procedures, and business ethics
• Perform miscellaneous assigned duties

Director, Clinical Operations

• Serve as subject matter expert in protein purification, drug product formulation, fill, and lyophilization
• Manage Iovance GMP manufacturing and contracted manufacturing operations for protein production and characterization, focusing on downstream processes
• Plan, coordinate, and oversee contract manufacturing and development services through the product life cycle
• Oversee process development, transfer, scale-up, validation, COGS improvements, and technical change/improvement studies
• Collaborate with Process Development, Analytical Development, Manufacturing, Quality Control, Quality, Supply Chain, and Regulatory functions
• Lead or support CMC product teams and subteams, manage technical information/data flows, milestones, audits, qualification, validation, and regulatory filing activities
• Manage manufacturing data for selected clinical/commercial products
• Support knowledge management, process and analytical strategy development, microbial control strategies, risk assessment, and mitigation
• Build relationships with key Contract Manufacturing Organizations
• Manage technical transfer and technical/COGS improvement projects, stakeholder engagement, and on-time/in-budget delivery
• Support regulatory CMC and registrational activities, especially ex-US
• Liaise with Quality and Supply Chain on product disposition and systems alignment; support investigations, deviations, CAPAs, and site audits
• Support hiring and staff development
• Ensure CMO operational readiness for campaigns, transfers, change controls, and validations
• Apply operational excellence and lean principles to develop efficient, robust systems

Associate Director – Regulatory Affairs

Senior Manager, Supply Planning

Director, Clinical Operations

Senior Manager, Protein Sciences – Downstream