Iovance Biotherapeutics, Inc.

Manager

• Serves as lead statistician for one or more clinical studies and may support program-level statistical strategy.
• Leads statistical activities for assigned studies and collaborates with statistical programmers and CRO partners to ensure timely delivery of high-quality statistical outputs.
• Authors and reviews statistical sections of study protocols, statistical analysis plans, clinical study reports, regulatory submission documents, and publications including abstracts and posters.
• Maintains current knowledge of statistical methodologies, regulatory guidance, and industry best practices relevant to oncology drug development.
• May contribute statistical expertise to due diligence activities and cross-functional evaluations when needed.
• Creates networks with external statistical and programming collaborators and influences internal decisions to ensure quality of study designs and analyses, appropriateness of inferences and conclusions, and alignment with corporate strategic interests.
• Contributes to process improvements, standards development, and statistical best practices within the Biostatistics function.
• Works effectively within cross-functional teams to address study-level operational and scientific challenges.
• Contributes to knowledge sharing within the department.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.

Senior Manager, Biostatistics

Software Engineer

• Develop, validate, and maintain SAS and/or R programs for the creation of SDTM, ADaM datasets, and TLFs in accordance with CDISC standards.
• Support statistical analyses for periodic safety reports, publications, conference presentations, IDMC/DSMB reviews, clinical study reports (CSRs), regulatory submissions, health authority requests and other ad hoc analyses and reporting needs.
• Ensure all programming activities comply with FDA 21 CFR Part 11, GxP, and internal SOPs.
• Collaborate with biostatisticians, data managers, and clinical teams to define analysis specifications and resolve data issues.
• Perform quality control and detailed review of statistical programs and outputs.
• Develop and maintain reusable macros, templates, and automation tools to improve programming efficiency.
• Contribute to the evaluation and implementation of emerging technologies and modern programming approaches, including AI-based tools and agents, to enhance statistical programming workflows.
• Participate in development and review programming data specifications.
• Maintain clear, thorough documentation to support audit readiness and regulatory inspection.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.

Contract Statistical Programmer

Account Manager

• Create and maintain high-impact investor relations and corporate communications materials, including press releases, earnings scripts, Q&A documents, corporate presentations, FAQs, fact sheets, executive biographies, website content, investor decks, templates, and social media content.
• Drive internal reviews, approvals, and final deliverables on behalf of the IR and corporate communications team.
• Support analyst and institutional investor engagement and help advance investor targeting strategies.
• Monitor metrics and analytics for multi-channel external engagement, media coverage, share of voice, company reputation, market activity, analyst sentiment, peer performance, and consensus estimates, to deliver real-time insights for leadership.
• Translate key milestones, including earnings, financings, clinical updates, and business developments, into timely, consistent communications for employees, investors, media, and other stakeholders.
• Own logistics, timelines, briefing materials, and execution support for events led by the team, including internal town halls, media interviews/roundtables and investor days.
• Support media relations by preparing press materials, tracking coverage, and helping build productive relationships with traditional and social media outlets.
• Manage agencies and vendors to keep projects moving, on budget, and aligned with investor relations and corporate communications priorities.
• Partner with Finance, Legal, Commercial, R&D, Patient Advocacy, and other teams to deliver accurate, consistent, and compliant communications across filings, disclosures, investor materials, the corporate website, internal meetings, and social media.
• Improve processes, tools, and workflows to increase the speed, organization, and scalability of the investor relations and corporate communications function.
• Lead or support priority investor relations and communications projects as business needs evolve.

Manager, Investor Relations – Corporate Communications

Compliance

• Responsible for submission planning, oversight of planning of IND related activities like Annual reports, Orphan drug reports, DSUR and other CTA activities for on-going study or study start-ups
• Managing the planning, compilation, QC, and submission of Investigational Drug Applications (INDs), Biologics License Applications (BLAs), and their amendments.
• Prepares routine IND and CTA amendments, for example, Annual Reports/DSURs, Investigator Packages, and SUSARs.
• Independently, under limited supervision manages 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.
• Represents Regulatory Affairs and provides regulatory expertise to cross-functional teams on specified projects and topics.
• Independently manages tracker 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.
• Prepare and compile effective presentations for external and internal audiences as needed.
• Other duties as assigned.

Senior Regulatory Affairs Specialist

• 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.

Senior Associate, Regulatory Affairs CMC

Associate

• Manages order process from order generation, changes, shipment and final delivery. Implement key performance measures to continuously refine and improve the product transport and on-time delivery at the lowest cost.
• Lead the maintenance and continuous improvement of the scheduling software system, driving new iterations, and enhancements to support evolving clinical trial requirements across end-to-end logistics, chain of custody, real-time tracking, and CMO capacity management.
• Co-lead the ongoing development of the commercial scheduling system, partnering cross-functionally to ensure seamless alignment between clinical and commercial operational needs.
• Work closely with the Director of Logistics and Planning to assist Commercial, Clinical, Manufacturing, and Quality Operations to develop logistic support in the execution of the production plan and patient schedules.
• Support logistics operations, including evening and weekend availability to ensure continuity across all operational windows.
• Troubleshoot and develop plans of action for both expected & unanticipated logistical issues during the transport of patient material and product.
• Develops, authors, and implements standard operating procedures and work instructions for logistics related processes.
• Proactively manages the sourcing, onboarding, performance and relationship of logistics couriers.
• Effectively support Clinical and Commercial Operations with new site onboarding.
• Collaborates effectively with multiple individuals and organizations in a cross-functional, team-oriented environment.
• Actively participate in Product/Study Teams to align demand/supply plans to program milestones and activities.
• Prepares, reviews and presents data, reports and presentations as assigned.
• Interface with all levels of organization, including senior management.
• Other duties as assigned.

Senior Logistics and Planning Associate

Medical Director

• 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

Director, Medical Affairs – Medical Science Liaison

QA Engineer

• 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

Auditor I, Clinical Quality Assurance

Therapist

• 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.

Cell Therapy Case Manager – Southeast

• 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.

Cell Therapy Case Manager

Recruitment

• Support and assist recruiters in coordinating with candidates/ managers/ staffing agency to schedule interviews (phone/onsite/Zoom) across multiple department/offices.
• Work with multiple scheduling changes and calendar changes with candidates and hiring managers.
• Update the Req Report with recruiting activity and information required.
• Post open positions on LinkedIn and other job posting boards.
• Attend weekly TA meetings with the team and recruiting meeting and able to speak to updates and activities.
• Adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.

Recruiting Coordinator

• 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.

Manager, Regulatory Affairs

• 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.

Associate Director – Regulatory Affairs

General

• 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.

Clinical Trial Assistant

General Counsel

• 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