Iovance Biotherapeutics, Inc.

Clinical Research

• Support the overall operational execution of clinical studies on one or more clinical programs from initial study synopsis through final project deliverables (ie, database hard-lock, final TLFs, CSR, etc.)
• Manage the implementation, on-time execution and conduct of clinical studies; including the development of budget items, milestones and timelines, in addition to scope and management of resources (including vendor selection). All leading to overall quality, safety, and compliance throughout the duration of the clinical studies and program.
• Oversight of cross-functional study team members to ensure initiation and execution of the clinical program within approved budget and timelines
• Risk management and mitigation including prioritization of competing tasks and issues to ensure program/study objectives are successfully accomplished.
• Lead role in vendor identification/qualification/selection, systems set-up/management including EDC, IWRS, Central Laboratories, specialty services (ePRO, eDiary, etc.)
• Understanding of how to support and deliver the trial endgame, which is the data and statistical analyses
• Critically assess data to detect trends and outliers to efficiently direct resources and attention to correct problems early
• Ability to critically review and supervise a multifunctional vendor groups including clinical operations, data management and biometrics
• Ensure data integrity through routine data reviews, query and resolution, consistency checks both internally and for independent DMC/DSC
• Effectively tracks and communicate program/study progress to Senior Management with ability to create and update detailed dashboards and trackers
• Awareness of competitive landscape, changing regulations and guidance with ability to assess the impact on clinical projects and make modifications as necessary
• Ability to creatively approach challenges and problem resolution to optimize the conduct of clinical trials
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.

Clinical Trial Manager

Compliance

• Support management of the planning, compilation, QC, and submission of CMC dossier content to clinical and commercial applications, and their amendments.
• Prepare and adapt submission documents for use in global clinical and commercial submissions following eCTD specifications and market specific requirements.
• May be responsible for independently planning and preparing routine clinical trial application related amendments and commercial submissions (e.g. Annual reports, DSUR, health authority queries).
• Independently manages submission trackers for coordination of submissions across multiple products.
• Maintains logs of clinical and commercial submissions and correspondence with FDA or other regulatory agencies.
• Facilitate communication with Vendors/ CROs for planning and tracking of source documents to ensure high-quality IND, IND amendments, CTA, EU-CTR submissions are delivered in timely manner.
• Support the implementation of regulatory strategy for assigned projects and programs for projects in all stages of development (IND through NDA/BLA approval and commercialization).
• Works with submission authors and reviewers to ensure that source document planning is complete and that high-quality documents are approved on-schedule in terms of scientific content, organization, clarity, accuracy, format, consistency and adherence to regulatory guidelines, styles and processes.
• Prepare and compile effective presentations for external and internal audiences as needed.
• Create documents in accordance with eCTD specifications.
• Perform miscellaneous duties as assigned.

Senior Regulatory Affairs CMC Associate

• Support management of the planning, compilation, QC, and submission of CMC dossier content to clinical and commercial applications, and their amendments.
• Prepare and adapt submission documents for use in global clinical and commercial submissions following eCTD specifications and market specific requirements.
• May be responsible for independently planning and preparing routine clinical trial application related amendments and commercial submissions (e.g. Annual reports, DSUR, health authority queries).
• Independently manages submission trackers for coordination of submissions across multiple products.
• Maintains logs of clinical and commercial submissions and correspondence with FDA or other regulatory agencies.
• Facilitate communication with Vendors/ CROs for planning and tracking of source documents to ensure high-quality IND, IND amendments, CTA, EU-CTR submissions are delivered in timely manner.
• Support the implementation of regulatory strategy for assigned projects and programs for projects in all stages of development (IND through NDA/BLA approval and commercialization).
• Works with submission authors and reviewers to ensure that source document planning is complete and that high-quality documents are approved on-schedule in terms of scientific content, organization, clarity, accuracy, format, consistency and adherence to regulatory guidelines, styles and processes.
• Prepare and compile effective presentations for external and internal audiences as needed.
• Create documents in accordance with eCTD specifications.

Regulatory Affairs CMC Associate II

• Manages the planning, compilation, QC, and submission of Investigational Drug Applications (INDs), Biologics License Applications (BLAs), and their amendments.
• Prepares routine IND and CTA amendments.
• Work with submission authors and reviewers to ensure that source document planning is complete and that high-quality documents are approved on-schedule.
• Represents Regulatory Affairs and provides regulatory expertise to cross-functional teams on specified projects and topics.
• Interface with Quality Assurance, clinical manufacturing, commercial manufacturing and other stakeholders to further develop and maintain a robust change control program.
• Work with cross-functional project teams to develop CMC regulatory strategy for product changes at all stages of development.
• Work within the CMC Regulatory Affairs team to gain consensus on proposed changes.
• Negotiate with internal stakeholders to ensure that proposed changes and submission content are aligned with ICH guidelines, country regulations and guidelines, and industry standards.
• Participate in risk mitigation by proactively identifying risk, developing options and contingency plans.
• Assists in developing and managing Gantt charts (in conjunction with Program Management) and trackers for submissions across the multiple products.
• Maintains logs of IND and CTA submissions and correspondence with FDA or other regulatory agencies.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.

Manager, Regulatory Affairs CMC

Systems Engineer

• Design, build, and ship AI systems against the approved Iovance AI roadmap
• Implement production-grade Retrieval-Augmented Generation (RAG) systems
• Build, maintain, and run evaluation harnesses for AI systems
• Design and implement integrations between AI systems and Iovance enterprise systems
• Own and maintain LLM security controls for production AI systems
• Design, develop, deploy, and maintain AI agents
• Establish and uphold modern engineering practices for AI development
• Conduct hands-on technical evaluation of AI vendors, tools, and Foundation Models
• Implement and operate technical controls for production AI systems
• Author technical documentation appropriate to the system risk tier
• Mentor junior engineers who collaborate on AI projects

Principal AI Systems Engineer

Artificial Intelligence

• Help build a comprehensive AI use case diagnostic across all business functions
• Build and maintain the AI savings model
• Design and execute controlled comparisons to validate AI solutions
• Manage the use case prioritization framework
• Write use case specifications detailed enough for the development team to build from
• Build rough prototypes using AI tools to validate use cases with stakeholders
• Support the AI governance process
• Supervise and quality-check the work of AI Transformation Interns

AI Strategy Associate

Full-stack Engineer

• Rapidly prototype, build, and deploy AI-powered micro-applications using React and Node.js/Python.
• Take rough prototypes and proof-of-concepts and convert them into production ready tools.
• Work directly with business stakeholders to understand their pain points and translate them into technical solutions.
• Build reusable components and patterns so each subsequent application ships faster than the last.
• Maintain clean, documented code and follow standardized build-test-deploy methodology.

AI Product Engineer

Procurement

• Drives the strategic and compliant sourcing of goods/services in support of key internal business partners: Site Technical Services (including facility Maintenance, Repair, and Operations), Engineering, Technical Development, and Manufacturing
• Oversees end-to-end outsourcing process, including execution of best-in-class sourcing strategies, supplier rationalization, Request for Proposal (RFP) coordination, cost negotiations, and due diligence
• Manages business case generation that summarizes competitive bidding process, scoring methodology, and selection justification for the most technically and commercially viable solution(s) for the required services, quality, and cost
• Identifies opportunities for supplier base consolidation, standardization, and innovation across diverse and potentially fragmented categories to support on-site manufacturing operational continuity and uptime
• Negotiates optimal terms, competitive pricing, favorable service level agreements (SLAs), and risk mitigation clauses with external manufacturing and analytical laboratory partners
• Streamlines long-term category strategies that achieve operational efficiency and continue to lower Iovance’s total cost of ownership (TCO)
• Leads procurement strategy for acquiring engineering and construction services, automation, and capital equipment.
• Leverages procurement best practices to recognize cost reduction and avoidance, achieving meaningful savings that improve organization’s financial performance
• Collaborates with the Legal and Finance organization to ensure the appropriate execution of key controls including third party agreements to protect Iovance interests with third party vendors.
• Leadership of cross-functional teams across business functions to drive initiatives that maximize value of external spend with third party suppliers
• Develops performance benchmarks and scorecards, including key performance indicator reporting for senior management to aid continuous improvement efforts
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics
• Perform miscellaneous duties as assigned

Associate Director, Engineering – Technical Services Procurement

QA Engineer

• Independently manage and monitor the processing, review, approval, archival, and distribution of revision- controlled documents in the Electronic Document Management System (eDMS).
• Provide user support and guidance on document workflows, processes, and system usage.
• Ensure documents meet formatting, content, and compliance standards prior to approval.
• Maintain document records to ensure accuracy, completeness, and traceability within the system.
• Coordinate document periodic reviews of controlled documents to ensure ongoing accuracy and compliance.
• Support internal and external inspections by retrieving documentation and ensuring inspection readiness.
• Independently manage training assignments and task execution within the Electronic Document Management System (eDMS).
• Generate and distribute training compliance reports for management and audit purposes.
• Support onboarding training activities and assignment of required curriculum.
• Identify and escalate process inefficiencies within document control and training workflows.
• Perform miscellaneous duties as assigned.

Quality Assurance Specialist I, Document Control and Training

Accounts Payable

• Perform day-to-day administration of all payment cycle activities and provide efficient client service.
• Manage full AP cycle for assigned vendors, including the related coordination with business process owners.
• Ensures correct sorting, general ledger coding, and matching invoices/receipts, where applicable.
• Verify that transactions comply with financial policies and procedures established by the Company.
• Ensure the Company’s authorization matrix approves invoices before payment.
• Collaborate with the Procurement team and assist with vendor purchase order inquiries.
• Research and resolve invoice discrepancies and issues.
• Correspond with vendors and respond to inquiries.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.

Accounts Payable Specialist – Contract to Hire

Business Operations

• Supports the identification and prioritization of deliverables across clinical departments (i.e., Medical Writing, Biostatistics, Drug Safety, Clinical Science), organizes cross-functional teams and tracks progress against goals and timelines
• Understands and advises on functional priorities within the context of enabling larger organizational success.
• Supports business planning, such as budget review, resource forecasting, goals review, etc.
• Supports business data collection and analysis, helps track delivery against corporate and department goals and collaborates with Department Heads on Quarterly Business Reviews
• Problem solves by leveraging understanding of business and functional relationships to activate right people and solutions.
• Spends time connecting individuals and teams within function, across functions and across the organization.
• Serves as a thought partner for vision and goal setting and partner with teams to drive functional short-to-long-term business planning and execution.
• Keeps Department meetings on track with focused agendas and objectives. Takes minutes and tracks deliverables as appropriate, follows up on deliverables as needed.
• Anticipates needs of CMO and Department Heads and prompts actions and conversations that enhances team success.
• Helps the CMO and Department Heads balance needs of the function and needs of the overall organization.
• Advises on new approaches to address organizational needs and complex challenges within Departments and broader organization
• Identifies opportunities to leverage synergies and eliminate redundancies, drives operational excellence, helps control spend
• Collaborates with PMO team to align on priorities, processes and tools
• Represents Clinical Organization in appropriate meetings and committees
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.

Associate Director, Clinical Business Operations Management

• Engage directly with team members and leaders across every major business function to understand how work gets done today—what’s working, what’s not, and where the friction is.
• Document end-to-end business processes with rigor and consistency, building a structured repository that becomes a lasting organizational asset.
• Build a comprehensive use case catalogue that captures, categorizes, and prioritizes opportunities where AI and automation can drive real operational improvement.
• Apply AI tools and large language models to analyze documented workflows, surface patterns, and develop preliminary solution concepts for high-priority opportunities.
• Translate complex findings into clear, well-organized deliverables—written summaries, process maps, and recommendation briefs—for both technical and non-technical audiences.
• Work directly with the Executive Director, COC/COI Systems and cross-functional partners to pressure-test assumptions, refine priorities, and align recommendations with organizational goals.
• Stay sharp on the evolving AI landscape and bring informed perspectives on how new capabilities could apply to the problems you’re seeing.

AI Transformation Analyst, Intern

• Works closely with functional leaders to 1) create the optimal development path for Iovance product candidates, 2) negotiate optimal development paths within internal cross-functional teams and with health authorities, 3) execute clinical-regulatory development plans on-time and while managing all identified risks.
• Collaborates with RA CMC Product Lead to execute CMC Submission and Authoring strategy for assigned project.
• Ensures that submission documents and correspondence are of the highest quality in terms of content, organization, clarity of writing, and accuracy.
• Ensures that evolving global regulations, guidelines and health authority expectations, especially those related to cell therapies, are incorporated into program decision making.
• Ensures writing activities meet quality standards and expectations and adhere to applicable Corporate SOPs, policies, guidelines, and regulation.
• Assures that standardized practices are implemented and maintained across regulatory documents.
• Collaborates with Regulatory Operations to ensure timely and accurate submissions
• Critically review source documents for consistency, completeness, and quality.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics
• Perform miscellaneous duties as assigned.

Associate Director, Regulatory Affairs CMC

Director

• Own and advance the regional field medical strategy within the assigned territory
• Lead delivery of high-quality scientific and clinical presentations on disease state(s) and Iovance products
• Strategically identify, map, and profile external experts
• Develop and sustain strategic relationships with healthcare professionals and clinical investigators
• Establish and maintain a high bar for insight quality
• Provide scientific leadership for Medical Affairs activities and scientific sessions at key congresses/meetings
• Lead strong cross-functional partnerships to ensure coordinated execution of the medical plan
• Model inclusive, professional leadership behaviors and contribute to a collaborative team culture
• Apply strong problem-solving, prioritization, and decision-making skills to address complex field challenges
• Demonstrate deep scientific/clinical expertise and executive presence
• Provide leadership and coaching and contribute to field medical capability building
• Operate in accordance with applicable laws, regulations, and company policies
• Perform miscellaneous duties as assigned.

Director, Medical Affairs – Medical Scientific Liaison

• Support the development and maintenance of economic models and global value dossiers for HTA submissions, managing/directing market access and HEOR consultants.
• Serve as project manager for global market access and HEOR activities, including tracking deliverables, coordinating document reviews, managing contracts, and ensuring alignment on timelines and cross-functional updates.
• Support global HEOR research projects, including review of analyses and development of publications for HTA submissions and payer responses, in collaboration with the HEOR team.
• Support development and execution of the evidence generation for payer needs in collaboration with medical affairs
• Manage external engagements, in a compliant manner, with HTA agencies, payers, key opinion leaders, and other stakeholders
• Communicate market access and HEOR strategy updates, insights, and recommendations to cross-functional partners and senior leadership.
• Develop and adapt value and access materials for priority global markets.
• Support planning and strategy for new indication launches, from the perspective of evidence and access
• Monitor and proactively communicate market access changes, challenges, and opportunities in priority markets.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.