Iovance Biotherapeutics, Inc.

• 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. • Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics. • Perform miscellaneous duties as assigned.

• Own and advance the regional field medical strategy within the assigned territory, ensuring impactful, fair-balanced, evidence-based scientific exchange and representing Iovance as a credible, trusted partner to the healthcare community • Lead delivery of high-quality scientific and clinical presentations on disease state(s) and Iovance products (approved and pipeline) to internal and external audiences; ensure appropriate use of approved materials, coach others on effective scientific communication, and uphold compliance requirements • Strategically identify, map, and profile external experts (e.g., KOLs, investigators, advocacy and healthcare system stakeholders) and develop and operationalize territory engagement plans that prioritize the highest-impact accounts and inform enterprise medical priorities • Develop and sustain strategic relationships with healthcare professionals and clinical investigators in academic and community settings; proactively identify scientific collaboration opportunities aligned with the medical plan (e.g., publications, advisory boards, investigator-initiated research support, and clinical trials, as applicable) and partner with internal stakeholders to enable execution • Establish and maintain a high bar for insight quality by collecting, synthesizing, and communicating actionable field medical insights using approved tools and processes; identify trends, elevate insights to internal stakeholders, and help drive insight-to-action discussions and follow-through • Provide scientific leadership for Medical Affairs activities and scientific sessions at key congresses/meetings; develop and execute regional congress engagement plans in coordination with internal stakeholders and support post-congress medical pull-through • Lead strong cross-functional partnerships (e.g., Medical Affairs, Clinical Science, Clinical Operations, Market Access, and Commercial) to ensure coordinated execution of the medical plan, appropriate and compliant information flow, and alignment on key priorities across the region • Model inclusive, professional leadership behaviors and contribute to a collaborative team culture through clear communication, reliable follow-through, and constructive partnership with internal and external stakeholders • Apply strong problem-solving, prioritization, and decision-making skills to address complex field challenges; anticipate needs of patients and the healthcare community, recommend solutions consistent with medical strategy, and appropriately escalate risks and opportunities • Demonstrate deep scientific/clinical expertise and executive presence, with the ability to communicate complex data clearly, accurately, and compliantly to a range of audiences and to influence medical decision-making • Provide leadership and coaching (e.g., onboarding, field shadowing, sharing best practices, peer mentoring) and contribute to field medical capability building; may serve as a people manager and/or lead for initiatives, as needed • Operate in accordance with applicable laws, regulations, and company policies (e.g., scientific exchange, privacy, adverse event reporting) and promptly escalate questions or issues through established channels • Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics. • Perform miscellaneous duties as assigned. • Ability and willingness to travel up to 60% of the time within the assigned territory, as business needs require

• Support GCP/GCLP/GVP audits for investigational sites, GCP internal systems and processes, trial master file and clinical service provider audits. Responsibilities include the planning, coordination, and timely reporting of such audits as well as appropriate escalations of critical observations • Support and assist with commercial inspections, inspection readiness activities and other related activities as needed • Support GCP compliance activities including investigations, clinical change controls, procedure development and review, ATC QA audits, and GCP training program development • Implement procedures and work instructions based on best practices or compliance requirements • Maintain a continuous process improvement initiative mindset in all areas of work • Represent the Clinical Quality Assurance Team in cross-functional projects where applicable

• Manage end-to-end patient cases for TIL therapy from referral through post-infusion • Serve as a primary contact and trusted advisor for patients and providers • Provide expertise on TIL therapy workflows including tumor procurement and manufacturing coordination • Collaborate with treatment centers and interdisciplinary care teams • Partner with internal teams to ensure alignment across time-sensitive milestones • Identify and resolve barriers to therapy access • Track critical milestones across the autologous treatment process • Support site onboarding and share best practices • Contribute to continuous improvement initiatives • Maintain current knowledge of and follow established IovanceCares objectives, processes, regulatory and compliance standards, policies, and procedures. • Demonstrate genuine passion and care for patients and uphold Iovance values in daily individual work performance. • Adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business • Perform miscellaneous duties as assigned.

• Manage end-to-end patient cases for TIL therapy from referral through post-infusion • Serve as a primary contact and trusted advisor for patients and providers • Provide expertise on TIL therapy workflows including tumor procurement and manufacturing coordination • Collaborate with treatment centers and interdisciplinary care teams • Partner with internal teams to ensure alignment across time-sensitive milestones • Identify and resolve barriers to therapy access • Track critical milestones across the autologous treatment process • Support site onboarding and share best practices • Contribute to continuous improvement initiatives • Maintain current knowledge of and follow established IovanceCares objectives, processes, regulatory and compliance standards, policies, and procedures.

• 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. • 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. • Prepares templates or shells for specific submissions based on company standards. • Perform miscellaneous duties as assigned.

• Collaborates closely with functional leaders to create the optimal development path for Iovance product candidates. • Negotiates optimal development paths within cross-functional teams and with health authorities. • Executes clinical-regulatory development plans on-time and while managing all identified risks. • Plans, manages, and creates Clinical Trial Applications, Market Applications, and amendments. • Ensures that submission documents and correspondence are of the highest quality in terms of content, organization, clarity of writing, and accuracy. • Leads cross-functional teams in developing strategic briefing packages and in preparing for health authority meetings or interactions. • Ensures that evolving global regulations, guidelines, and health authority expectations are incorporated into program decision making. • Works within the department and with other functional areas on process improvements. • Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.

• Adhere to Clinical Standard Operating Procedures and Good Clinical Practice ICH Guidelines. • Assist in contacting investigator sites to provide study specific information. • Ensure receipt, completeness and accuracy of clinical and administrative documents. • Coordinate distribution and shipment of study-related materials. • Coordinate investigator site/payment as needed. • Maintain telephone contact with sites, contract research organization personnel, vendors and CRAs as needed. • Facilitate flow and maintenance of correspondence with sites. • Attend clinical project team meetings and takes minutes. • Contract, invoice and budget management and tracking. • Assist in coordination of study initiation documentation materials. • Responsible for compiling/QC checking/generating copies of clinical documents that are intended for submissions including 1572s (original and updated), Informed Consent Form, Protocol and Investigator’s Brochure. • Coordinate distribution of study team materials and meeting minutes. • Draft and prepare documents for mass mailings (e.g., protocol amendments). • Assist with preparation of presentation materials. • Maintain central registry of contact information for clinical sites, contract research organizations, vendors and CRAs. • Set up teleconference calls with sites and team and record minutes. • Maintain central monitoring calendar for all site visits. • Create and maintain Central Clinical files. • Perform administrative and clerical duties. • Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics. • Perform miscellaneous duties as assigned.

• Review, negotiate and manage third party contracts, including master services agreements, commercial agreements, consulting agreements, confidentiality agreements, collaboration agreements, supply agreements and other agreements • Manage and analyze existing contract templates and work to develop new templates and updating existing templates in accordance with company guidelines and policies or Legal Department requirements • Supports and advises internal clients on the company’s contract management system and policies • Works collaboratively with other in-house attorneys and paralegals in the Legal Department to quickly achieve goals • Create and conduct legal training for employees and provide on-going training to internal clients on contract processes and other company policies • Research, analyze and make appropriate recommendations to business partners in order to resolve legal and business issues • Prepare contract summaries and issue lists for executives • Monitor compliance with internal company business and legal processes and policies

• Review, negotiate and manage third party contracts, including various agreements • Manage and analyze existing contract templates and develop new templates • Supports and advises internal clients on the company’s contract management system • Works collaboratively with other in-house attorneys and paralegals in the Legal Department • Create and conduct legal training for employees • Research, analyze and make recommendations to business partners to resolve legal issues • Prepare contract summaries and issue lists for executives • Monitor compliance with internal company business and legal processes