Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview

The Associate Director, Regulatory CMC works collaboratively within the CMC regulatory and technical operation teams on writing projects for early, late-stage development, and commercial programs. They contribute to the drafting, reviewing and finalization of CMC content and/ or regulatory related documents. The individual also apply writing/editorial expertise to the development of CMC/Quality (Module 3) sections for filing and maintenance of initial INDs, initial CTAs (IMPDs), FDA BLA, EMA MAA, ROW submissions as well as CMC source documents. This position works closely with stakeholders to support corporate and departmental objectives. An important aspect of this role is the planning and management of writing projects. Attention to detail in their work and ability to collaborate with diverse internal and external stakeholders are both important factors for success in this role.

Essential Functions and Responsibilities

• 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.  

Required Education, Skills, and Knowledge

• Minimum of a BA/BS in Life Science
• 5-8 years pharmaceutical/biotechnology experience related to analytical/pharmaceutical chemistry and/or regulatory affairs.
• Demonstrated expertise in writing/developing CMC content in Briefing Documents, Quality Amendments, Module 2 and Module 3 updates and CMC source documents in support of US and global regulatory submissions (with primary interest in the areas of Biologic and Cell Therapy Products).
• Understanding of biological lifecycle drug development
• Experience with ICH, CTD and electronic submission guidelines for regulatory reports.
• Excellent written and verbal skills
• Ability to collaborate with a wide variety of internal customers and relate effectively to people at all levels of the organization
• Excellent computer skills including MS Office (Word, Excel, Power Point, Outlook); experience with electronic document management systems and other content authoring technologies (e.g. Veeva Vault)
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Proven track record with project management and experience with GDP, GCP, and GMP. Ability to handle multiple projects simultaneously.
• Excellent attention to accuracy and detail.
• Create and maintain core dossier and CMC Authoring templates

Preferred Education, Skills, and Knowledge

• Graduate degree preferred

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation. 

Physical Demands and Activities Required 

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.  
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information.

Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines

Work Environment 

This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards.  

#LI-remote

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview

The Director, Medical Affairs (Medical Science Liaison) is a field-based medical leader responsible for shaping and executing regional field medical strategy for Iovances developmental and marketed products through high-impact scientific exchange, generation and communication of actionable medical insights, and cross-functional partnership. This role develops and sustains relationships with regional and national external experts (e.g., key opinion leaders, investigators, and healthcare systems) and leads territory planning and prioritization to support medical objectives, including clinical trial site identification and execution, consistent with applicable laws, regulations, and company policies. The Director operates with a high degree of autonomy and accountability, provides strategic thought leadership within the field medical organization, and helps establish consistent standards, processes, and capability building across the team, including coaching and mentoring as assigned.

Essential Functions and Responsibilities

• 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.

Travel

• Ability and willingness to travel up to 60% of the time within the assigned territory, as business needs require

Required Education, Skills, and Knowledge

• 12 to 15+ years of relevant biopharmaceutical/biotechnology industry experience, including 7 to 10+ years in Medical Affairs and/or an MSL role with increasing scope, strategic leadership, and accountability
• Advanced scientific degree (MD, PhD, PharmD)
• Demonstrated capability in needs assessment, facilitation, prioritization, decision making, collaboration, planning and organizing, execution and follow-up, with strong written and verbal communication and the ability to influence senior stakeholders in a matrix environment
• Strong meeting management skills and operational capabilities, including use of metrics/KPIs, documentation, and continuous improvement to drive consistent field execution
• Demonstrated ability to influence and align stakeholders within a complex matrix environment without direct authority; comfortable engaging with senior leaders and external experts
• Ability to manage competing priorities and deliver high-quality work within timelines
• Ability to work effectively within a matrix organization to achieve desired outcomes

Preferred Education, Skills, and Knowledge

• Experience as an MSL (or relevant industry role) and experience in oncology/immuno-oncology (e.g., melanoma and/or lung cancer) and/or cellular therapy
• Familiarity with the assigned territory and relevant external experts/healthcare systems
• Understanding of regulatory requirements for field-based personnel 
• Demonstrated ability to present effective and influential oral presentations
• Proven ability to coordinate across diverse functions, ensuring comprehensive and consistent planning
• Experience managing project and/or department budgets, resourcing, and vendor partnerships, aligning investments with strategic direction and demonstrating fiscal stewardship
• Demonstrated people leadership (direct and/or indirect), including hiring, onboarding, coaching, performance development, and leading through change

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required

• Ability to travel, usually within the US; field-based position with potential for significant travel
• Ability to remain in a stationary position (sitting or standing) for extended periods, as needed, with or without reasonable accommodation
• Ability to move within a home or office environment and to position and transport typical work materials and equipment, with or without reasonable accommodation
• Ability to review and analyze scientific/medical information and work on a computer for extended periods, with or without reasonable accommodation
• Ability to perform repetitive hand/wrist motions associated with computer and mobile device use, with or without reasonable accommodation
• Ability to communicate and exchange information with internal and external stakeholders, with or without reasonable accommodation

Cognitive and organizational requirements: Ability to apply sound judgment; analyze and interpret information; solve problems; maintain confidentiality and discretion; manage multiple priorities; and meet timelines, with or without reasonable accommodation

Work Environment

This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards. 

#li-remote

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview

Amtagvi™ is the best-in-class cell therapy treatment for advanced melanoma. The Cell Therapy Account Management (CTAM) will be responsible for driving Amtagvi demand by building a robust referral network between community practices and academic centers; enable early patient identification and streamline referral pathways; and collaborate with internal teams to enhance scientific and operational excellence in cell therapy account management.

To succeed in this role, you will use prior experience to optimize territory strategy in the oncology rare disease space and have demonstrated experience influencing others and building relationships. Additional competencies include experience with immunotherapy and solid tumor cancer, as well as prior launch experience, demonstrated ability to drive demand, pull through, and sustain the growth of Amtagvi™.

Essential Functions and Responsibilities:

• Drive Amtagvi^TM demand and appropriate pull-through at targeted ATCs and serve as a liaison between community oncology practices and internal stakeholders to align initiatives with business and medical objectives.
• Serve as the primary commercial point of contact for the Iovance iPOD at authorized treatment centers offering commercially available Amtagvi^TM. Serve as the commercial lead for developing and onboarding a new TIL service line at target ATCs.
• Educate site personnel on clinical and product information for Amtagvi^TM.
• Provide knowledge and expertise around Iovance products and processes to all service line customer stakeholders.
• Collaborate with ATC Operations, aligning Iovance Cell Therapy logistics, processes, and operations.
• Provide exemplary customer service while building business relationships with key clinical thought leaders, Amtagvi^TM prescribers, and other institutional stakeholders to influence the uptake of Amtagvi^TM.
• Develop and maintain applicable disease state, product-specific (Amtagvi^TM), and competitive landscape knowledge.
• Attend and support professional meetings and congresses regionally and nationally.
• Facilitate engagement with key thought leaders, Cell Therapy prescribers, and other institutional stakeholders.
• Maintain a high level of collaboration and communication with Iovance cross-functional partners in Market Access, Operations, Quality, Marketing, Medical, and others to ensure appropriate patient identification, infusion of Amtagvi^TM, and clinical care related to Amtagvi^TM.
• Facilitate and provide timely feedback to appropriate Iovance management regarding account business trends, changes in the therapeutic landscape, industry issues, and business opportunities.
• Collaborate with the sales leadership team to develop and implement strategic account plans in qualified academic institutions and large community medical oncology practices.
• Maintain compliance with US/global healthcare laws and regulations.
• Exemplify Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.

Travel – 50%

Required Education, Skills, and Knowledge:

• 8-12 years of related experience with a bachelor’s degree; or 6 years and a master’s degree; or a PhD with 3 years’ experience; or equivalent experience in a similar role within oncology/cell therapy or rare disease. Some barriers to entry exist at this level, requiring department review.
• Uses strategic foresight to optimize strategy and build service lines at academic hospitals. 
• Oncology/cell therapy or rare disease experience is required.
• Demonstrates deep market knowledge of the oncology and immunotherapy market, including reimbursement and policy landscape within academic hospitals, oncology clinics, and extensive community practices.
• Prior experience of products and therapies requiring complex delivery systems, including logistics management and regulatory and compliance requirements (i.e., GMP, Quality systems),
• Ability to coach and drive alignment with field-based and internal cross-functional partners.
• Uses data analytics to optimize decision-making and planning around Amtagvi’s uptake strategy.
• Demonstrate initiative, high sense of urgency, and perseverance in a fast-paced, entrepreneurial environment.
• Must have a valid driver's license.

  Preferred Education, Skills, and Knowledge

• MBA or other related graduate-level degree is preferred.
• New product launch experience
• Experience in oncology care, new product launches, and cell therapy is preferred.

Physical Demands and Activities Required

• Must be able to remain in a stationary position, standing or sitting for prolonged periods of time.
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to prepare and analyze data and figures, view a computer screen, and read extensively.
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information.

Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines

Work Environment

This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards.

#LI-Remote

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview

The Clinical Data Manager II will be responsible for assisting the lead data manager in end-to-end Data Management activities. He/she will participate as an active member of a multi-disciplinary team to plan, lead and execute the Data Management tasks required for phase 1-4 studies. The candidate must have a broad, fundamental knowledge of the data management process and should be able to perform most required tasks with guidance after receiving instructions and / or training The Clinical Data Manager II should be able to:

Essential Functions and Responsibilities

• Ensure the integrity, accuracy and compliance of clinical trial data
• Assist during a study database in RAVE to include but not limited to:
  • Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design
  • Assist with the development of data edit check specifications and data listings
  • Perform User Acceptance Testing (UATs) of Electronic Data Capture (EDC) systems according to company processes
  • Assist with the review of migration reports to ensure database build accuracy
• Perform reconciliation of data from external data sources against the clinical database
• Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines
• Execute data cleaning and discrepancy management to ensure compliance with the protocol
• Track and report study metrics to internal and external stakeholders
• Create or update Data Management Plan (DMP), Data Review Plan (DRP), eCRF Completion Guidelines (eCCGs) and other Data Management required study documents
• Perform database lock and freeze activities per company SOPs

Required Education, Skills, and Knowledge 

• At a minimum, Bachelor's degree required in the scientific or healthcare field
• At least 5 years' experience in Data Management for the pharmaceutical / biotechnology industry, or equivalent experience in an FDA-regulated environment including study lead experience
• Oncology experience is a must
• RAVE database experience is preferable
• Must have good time management skills and a proven ability to multitask
• Possesses a comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice.
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
• Possesses strong English language written and verbal communication skills.
• Able to travel to off-site meetings or training seminars as needed.
• Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications.
• Experience in Coding (MedDRA and WHODrug), Site and User Management and Lab Normal Range (LNR) entry in Rave is a plus
• Must be able to work collaboratively in a fast-paced environment

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required

• Must be able to remain in a stationary position standing or sitting for prolonged periods of
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects
• Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information 

Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.

Work Environment

This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards.

#LI-remote

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview

The Associate Director, Finance Systems & Processes will lead the design, optimization, and governance of Finance systems, data, and end‑to‑end planning processes across the organization. This role is responsible for driving scalable, efficient, and data‑driven planning, forecasting, reporting, and analytics capabilities in close partnership with Finance leadership, IT, and business stakeholders.

The role sits at the intersection of finance, technology, and process excellence, ensuring FP&A tools and workflows support strategic decision‑making, operational agility, and business growth.

Essential Functions and Responsibilities

Finance Systems Leadership

• Own the roadmap, administration, and continuous enhancement of FP&A systems (e.g., planning, forecasting, reporting, analytics platforms).
• Partner with IT and external vendors to implement system enhancements, upgrades, and new capabilities.
• Serve as the finance subject‑matter expert for FP&A systems architecture, data models, and integrations.

Process Design & Standardization

• Lead the design and standardization of end‑to‑end Finance processes, including:
  • Annual planning and long‑range planning
  • Forecasting and close‑to‑forecast cycles
  • Management reporting and dashboards
  • Scenario modeling and what‑if analysis
• Identify opportunities to streamline manual processes, eliminate redundancy, and improve cycle times.

Data & Analytics Enablement

• Ensure data integrity, consistency, and governance across Finance systems and upstream/downstream data sources.
• Enable advanced analytics, self‑service reporting, and management insights through improved tools and processes.
• Partner with finance leaders to translate business requirements into scalable system and data solutions.

Stakeholder & Change Management

• Act as a trusted partner to FP&A team, iCTC Finance and corporate functions.
• Lead user adoption through training, documentation, and change‑management initiatives.
• Align system capabilities with evolving business needs and strategic priorities.

Governance & Controls

• Establish and maintain controls, documentation, and operating procedures for FP&A systems.
• Collaborate with IT and Internal Audit to ensure compliance with internal controls, audit requirements, and data security standards.

Team Leadership (as applicable)

• Lead, develop, and mentor a team of FP&A analysts
• Set priorities, allocate resources, and manage project timelines and deliverables.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.

Key Competencies

• Strategic thinking with strong execution discipline
• System-oriented and highly analytical mindset
• Strong stakeholder influence and change‑management capability
• Continuous improvement and operational excellence focus
• Ability to balance near‑term delivery with long‑term platform scalability

Required Education, Skills, and Knowledge

• Bachelor’s degree in Finance, Accounting or related field.
• 10+ years of experience in FP&A, finance transformation, or finance systems roles, with at least several years in a leadership capacity.
• Deep knowledge of FP&A processes and financial planning concepts.
• Hands‑on experience with FP&A platforms and reporting tools such as enterprise planning (Net Suite or SAP), forecasting (Adaptive or TM1) or BI solutions.
• Strong process‑design, problem‑solving, and project‑management skills.
• Ability to communicate complex technical concepts to finance and non‑finance stakeholders.

Preferred Education, Skills, and Knowledge

• MBA, CPA, or similar advanced credentials.
• Experience leading finance transformation or system implementation initiatives.
• Familiarity with advanced analytics, automation, or data visualization tools.
• Ability to implement and utilize AI tools to enhance finance-related processes
• Experience working in a matrixed global organization.

Physical Demands and Activities Required

The physical demands described here represent those an employee may encounter while performing the essential functions of this job. Reasonable accommodation may be provided to enable individuals to perform these functions.

• Ability to remain in a stationary position for extended periods
• Ability to move about within an office or remote workspace and exert up to 10 pounds of force occasionally
• Visual acuity sufficient for preparing and analyzing data, viewing computer screens, and extensive reading
• Repetitive motion involving wrists, hands, and/or fingers
• Ability to communicate effectively to exchange information
• Cognitive: Ability to engage in analytical, conceptual, and problem‑solving activities in a dynamic business environment

Work Environment

This role operates in a professional office or remote work environment and requires routine use of standard office equipment and technology. Employees working remotely are expected to maintain a safe workspace free from recognized hazards.

Equal Employment Opportunity

#LI-remote

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview

Iovance is seeking a Sr. Director, Total Rewards and Operations for leading the global total rewards and HR operations function.  Reporting directly to the Executive Vice President of Human Resources (EVP HR), will be responsible for innovating, developing, directing and administering Iovance’s total rewards programs encompassing all compensation and benefits programs  Ensures our rewards philosophy is competitive, equitable, compliant, and aligned with the company's business strategy, mission, and values, supporting talent attraction and retention globally. Overseeing HRIS and HR Operations administration, driving all HRIS initiatives and with deep collaboration with HR business partners the focus of this position is to optimize and execute the delivery of total rewards programs and services to the business.

Essential Functions and Responsibilities

• As subject matter expert propose, design and implement industry best practices and lead effective, competitive, compliant and fair total rewards programs.
• Ensure all compensation and benefits programs comply with global regulatory requirements (e.g., FLSA, GDPR, pay equity laws) and are administered efficiently and accurately.
• Partner with Finance and Legal teams on budgeting, financial planning, and the legal aspects of plan design and implementation.
• Global responsibility for the management of the annual compensation planning programs including the modeling for compensation programs, competitive market assessment, structure / range development, administration of the corporate incentive plan, and annual equity program.
• Partner with HRBPs to address rewards, retention needs, and development of total rewards communications and trainings; provide advice on total rewards.
• Drive market competitiveness by conducting comprehensive benchmarking and salary surveys to attract and retain top talent. Make data-driven recommendations on changes to compensation at individual, departmental, and enterprise levels.
• Oversee equity strategy and modeling to ensure our programs are competitive and attract and retain talent.
• Prepare materials for Compensation Committee meetings.
• Lead and develop a high-performing HR Operations and Rewards team.
• Optimize and provide continuous improvement expertise to HRIS programs, seeking out and implementing efficiencies.
• Other duties as assigned.

Required Education, Skills, and Knowledge

• Bachelor’s degree in HR, Business or related field required.
• A minimum of 12+ years of hands-on total rewards, compensation and benefits experience with demonstrated progression in responsibility in a fast-paced, growth environment.
• Deep knowledge of executive and non-executive compensation programs including equity planning and practices, base salary, variable pay and performance management, job evaluation, data analysis, research and predictive and project modeling.
• Strong analytical skills with an emphasis on key insights, trends, issue identification and recommendations.
• Previous management experience. Demonstrated experience with mentoring and coaching others.
• Strong problem-solving aptitude, creative, flexible and consultative; strong sense of business needs and making decisions based on data and emerging priorities; high integrity and accountability.
• Ability to listen and use critical thinking to assess the needs and communicate accurate information concerning processes, plans and procedures in a collaborative, team-based manner.
• Detail-oriented, proven ability to track, prioritize and drive to success multiple concurrent projects by analyzing data and driving sound decision-making.
• Thrives in and enjoys a collaborative team setting and is driven by a desire to be innovative in a high energy, growing company environment.
• Strong customer orientation.
• Ability to handle highly sensitive, proprietary and confidential information appropriately.
• Life Sciences experience preferred.
• International experience (policy and compliance) also preferred.
• Workday experience strongly preferred.

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.

Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines

 Work Environment

This position will work in an office setting.

#LI-remote

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview

In the US Cell & Gene (CGT) Marketplace, the payer is not only our Commercial and Government Health Plans, but also the Formulary Decision Makers within our Authorized Treatment Centers (ATCs) who are evaluating the financial viability of our therapies against all other Cell & Gene therapies (CGTs). Iovance is seeking Health Economic Value Access and Strategy (HEVAS) Director as a part of the US Market Access function to develop and translate economic evidence into value-based messaging and will be responsible for developing payer resources, billing & coding guides and patient support in alignment with our value proposition. This individual will understand Payer, hospital and provider clinic evaluation and financial feasibility to support the US Payer field team with pre-approval market readiness (FDAMA 114), cost of care / site of care and cost-effectiveness for our key formulary decision makers. This Market Access leader will partner cross-functionally to identify pricing strategies for our approved and pipeline therapies by understanding the US Cell and Gene Market environment needs, impact to GTN, and risk for price erosion. This is an individual contributor role with strategic leadership responsibility and no direct people management.

Essential Functions and Responsibilities

• Partner with Policy and Payer Marketing on engagement strategy with external partners and formulary decision-makers primarily in national/regional health plans, CMS, integrated delivery networks (IDNs), ATCs, Large physician groups (LPGs)
• Owns the development and execution of payer resources, reimbursement resources, end-to-end payer and channel marketing; provides resources to support the market access field team and pull through strategies
• Build and drive the US value proposition story for AMTAGVI and pipeline therapies to include but not limited to impact of complete and partial responses on PROs, productivity and future treatment costs and pharmacoeconomic impact of evolving treatment patterns
• Incorporate health economics, business analytics and competitive intelligence into the development of innovative strategies to gain, improve and defend public and private market access, specifically, pricing (and contracting) strategic planning within Market Access to create innovative proposals to meet public and private payer needs
• Directs the strategy and maintenance of formulary submission packages, total cost of care US models and other economic modeling and healthcare resource use analyses
• Support field-based cross-functional teams to provide pharmacoeconomic expertise in access engagements
• Manages operations and ensures compliance of Iovance Pricing Committee, GTN implications review and update charter and plan agendas to drive development of Committee recommendations
• Assess clinical and economic data gaps at key accounts and collaborate with internal stakeholders: Medical, Policy, Reimbursement HEOR, Payer Accounts, Marketing, Legal to provide insight into health economic value needs
• Support Market Access Account team(s) with Payer and Formulary Decision Makers at key congresses, such as PCMA, AMCP, ASTCT as needed
• Work cross functionally as a liaison with the brand teams to develop, implement, and communicate strategies and tactics to ensure alignment within the Market Access team on key cross-functional priorities
• Partnering with Commercial Strategy on Market Readiness, trial design and endpoint considerations, FDAMA and value evidence creation and Go-to-Market approach
• Assist on pipeline products and indications to generate key evidence and value proposition
• Provide strategic support and clinical-economic content expertise in innovation and partnership opportunities
• Operate at the highest level of compliance and professional standards demonstrated by embracing ethical decision-making practices and guidelines in all aspects of our organization
• Acts as the subject matter expert for all health care economic policy
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties assigned

Travel - Travel required, including overnights and some weekends (up to 20%)

Required Education, Skills, and Knowledge

• Doctorate degree (PharmD, MD, DO or PhD) preferred, or equivalent combination of advanced degree and relevant experience
• 12 + years background/experience in pharmacoeconomic, cost-effectiveness, HEOR and payer interactions
• Cell therapy, Hematology/Oncology experience preferred
• Proven ability to develop and maintain relationships with key decision-makers in the US healthcare/economics ecosystem
• Experience in assessing and analyzing clinical and HEOR data gaps to provide relevant access solutions
• Must be a strong team player and effectively interface with other internal departments including regional business units, marketing, sales, medical affairs, and clinical operations
• Excellent communication and presentational skills
• Ability to take initiative and work both independently and in a team environment multi-tasking, time management, and organizational skills with proficiency in Microsoft applications

Physical Demands and Activities Required

The physical demands described here represent those an employee may encounter while performing the essential functions of this job. Reasonable accommodation may be provided to enable individuals to perform these functions.

• Ability to remain in a stationary position for extended periods
• Ability to move about within an office or remote workspace and exert up to 10 pounds of force occasionally
• Visual acuity sufficient for preparing and analyzing data, viewing computer screens, and extensive reading
• Repetitive motion involving wrists, hands, and/or fingers
• Ability to communicate effectively to exchange information
• Cognitive: Ability to engage in analytical, conceptual, and problem‑solving activities in a dynamic business environment

Work Environment

This role operates in a professional office or remote work environment and requires routine use of standard office equipment and technology. Employees working remotely are expected to maintain a safe workspace free from recognized hazards.

#LI-remote

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview

Amtagvi™ is the best-in-class cell therapy treatment for advanced melanoma. The Cell Therapy Account Management (CTAM) will be responsible for driving Amtagvi demand by building a robust referral network between community practices and academic centers; enable early patient identification and streamline referral pathways; and collaborate with internal teams to enhance scientific and operational excellence in cell therapy account management.

To succeed in this role, you will use prior experience to optimize territory strategy in the oncology rare disease space and have demonstrated experience influencing others and building relationships. Additional competencies include experience with immunotherapy and solid tumor cancer, as well as prior launch experience, demonstrated ability to drive demand, pull through, and sustain the growth of Amtagvi™.

Essential Functions and Responsibilities:

• Drive Amtagvi^TM demand and appropriate pull-through at targeted ATCs and serve as a liaison between community oncology practices and internal stakeholders to align initiatives with business and medical objectives.
• Serve as the primary commercial point of contact for the Iovance iPOD at authorized treatment centers offering commercially available Amtagvi^TM. Serve as the commercial lead for developing and onboarding a new TIL service line at target ATCs.
• Educate site personnel on clinical and product information for Amtagvi^TM.
• Provide knowledge and expertise around Iovance products and processes to all service line customer stakeholders.
• Collaborate with ATC Operations, aligning Iovance Cell Therapy logistics, processes, and operations.
• Provide exemplary customer service while building business relationships with key clinical thought leaders, Amtagvi^TM prescribers, and other institutional stakeholders to influence the uptake of Amtagvi^TM.
• Develop and maintain applicable disease state, product-specific (Amtagvi^TM), and competitive landscape knowledge.
• Attend and support professional meetings and congresses regionally and nationally.
• Facilitate engagement with key thought leaders, Cell Therapy prescribers, and other institutional stakeholders.
• Maintain a high level of collaboration and communication with Iovance cross-functional partners in Market Access, Operations, Quality, Marketing, Medical, and others to ensure appropriate patient identification, infusion of Amtagvi^TM, and clinical care related to Amtagvi^TM.
• Facilitate and provide timely feedback to appropriate Iovance management regarding account business trends, changes in the therapeutic landscape, industry issues, and business opportunities.
• Collaborate with the sales leadership team to develop and implement strategic account plans in qualified academic institutions and large community medical oncology practices.
• Maintain compliance with US/global healthcare laws and regulations.
• Exemplify Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.

Travel – 50%

Required Education, Skills, and Knowledge:

• 8-12 years of related experience with a bachelor’s degree; or 6 years and a master’s degree; or a PhD with 3 years’ experience; or equivalent experience in a similar role within oncology/cell therapy or rare disease. Some barriers to entry exist at this level, requiring department review.
• Uses strategic foresight to optimize strategy and build service lines at academic hospitals
• Demonstrates deep market knowledge of the oncology and immunotherapy market, including reimbursement and policy landscape within academic hospitals, oncology clinics, and extensive community practices.
• Prior experience of products and therapies requiring complex delivery systems, including logistics management and regulatory and compliance requirements (i.e., GMP, Quality systems),
• Ability to coach and drive alignment with field-based and internal cross-functional partners.
• Uses data analytics to optimize decision-making and planning around Amtagvi’s uptake strategy.
• Demonstrate initiative, high sense of urgency, and perseverance in a fast-paced, entrepreneurial environment.
• Must have a valid driver's license.

  Preferred Education, Skills, and Knowledge

• Oncology/cell therapy or rare disease experience preferred.
• MBA or other related graduate-level degree is preferred.
• New product launch experience
• Experience in oncology care, new product launches, and cell therapy is preferred.

Physical Demands and Activities Required

• Must be able to remain in a stationary position, standing or sitting for prolonged periods of time.
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to prepare and analyze data and figures, view a computer screen, and read extensively.
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information.

Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines

Work Environment

This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards.

#LI-Remote

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview

The Regional Account Director is a key position in the National Cell Therapy Account Team, reporting directly to the Vice President of Sales. Their primary responsibility is to develop and lead their region's Cell Therapy Account team. The individual must have extensive experience in oncology, both in hospital and community settings, as well as expertise in launching new products. Additionally, the RAD will work closely with the commercial leadership to ensure the successful product launch of Lifileucel by driving demand uptake and sustaining its growth. The individual should possess a high level of initiative and be willing to take a hands-on approach to ensure success.

Essential Functions and Responsibilities 

• Directs a high-performing regional Cell Therapy Account Managers (CTAMs) team. This team will be accountable for successfully executing the IOVANCE commercial strategy for Lifileucel in their region.
• Enable demand by identifying, evaluating, and assisting in qualifying potential Lifileucel Authorized Treatment Centers (ATC)
• Build relationships and trust with ATC key stakeholders.
• Educating ATCs on best practices around our products and services.
• Lead collaborations with regional cross-functional teams such as Market Access, Commercial Quality, Marketing, Business Analytics, Human Resources, Legal, and other Iovance partners to ensure efficient customer engagement, including ATC Pre-calling, Call Continuum, and post-call activities.
• Provide training, coaching, and development of the commercial field-based organization in all phases of their work, including career development.
• Maintain compliance with corporate policies and procedures as well as with US/global healthcare laws and regulations.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.

Travel 

• Ability to travel up to 75% of the time.

Required Education, Skills, and Knowledge 

• 12+ years Oncology/Biotechnology experience, 5+ years leading and managing teams.
• Experience and strong understanding of the community oncology practice landscape.
• Exemplary leadership skills and a proven track record of achieving goals and objectives.
• Possess excellent coaching, analytical, and critical thinking skills.
• Proven ability to hire, lead, and commercially deliver in a complex therapeutic landscape.
• Demonstrated track record of retaining talent and career development of high-potential team members.
• Ability to lead a team in the academic hospital and community oncology markets while modeling the skill sets required to be successful.
• High clinical aptitude in the field of oncology and immunotherapy, as well as operational acumen in the academic hospital and community oncology setting.
• Demonstrates high-level knowledge and understanding of regulatory and compliance requirements, as well as oncology reimbursement and policy landscape.
• Experience managing and executing strategic planning, problem-solving, and conflict resolution in academic institutions and large community oncology practices.
• Experience in building positive team culture grounded in patient-centricity and organizational values.
• Proven track record of high performance and demonstrated ability and desire to provide unprecedented customer support across a broad group of stakeholders.
• BA or BS degree is required.
• Must have a valid driver’s license.
• Exceptional interpersonal and influencing skills.
• Strong written and verbal communication skills skills.
• Ability to build consensus across multiple cross-functional teams.
• Proven ability to successfully communicate and execute organizational goals and brand strategies.
• Exceptional organizational and time management skills.
• Outstanding presentation skills.

Preferred Education, Skills, and Knowledge

• Launch experience in solid tumor markets preferred.
• Experience developing and building out service lines at academic hospitals is preferred.
• MBA or other related, graduate-level degree is preferred.

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request accommodation.

Physical Demands and Activities Required

• Must be able to remain in a stationary position, standing or sitting for prolonged periods of time.
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to prepare and analyze data and figures, view a computer screen, and read extensively.
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information.

Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.

Work Environment

This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards.

#LI-remote

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview

The Lifecycle leader (LCL) is responsible for shaping the program vision, strategic context, and lifecycle plan (LCP) across indications globally. The LCL oversees the development and execution of the LCP in line with the company strategy.  They are able to navigate complex program challenges, the commercial and development landscape and assess and prioritize development in future indications.

Essential Functions and Responsibilities

• The LCL is responsible for shaping the program's cross-functional vision, strategic context, and lifecycle plan (LCP) for both current and future business opportunities.
• The LCL, in partnership with the Program Manager, will work with leadership & SMEs (subject matter experts) to build out appropriate internal ways of working to enable best practices around development of data driven recommendations, decision making and communication.
• As the single point of accountability in a cross-functional team, the LCL ensures timely delivery and manages the associated execution plan and milestones, closely aligning them with the approved LCP.
• The LCL oversees integration across Iovance involving multiple stakeholders to ensure optimal program execution in line with program strategy and LCP.
• Collaborating with functional team leaders, the LCL fosters alignment across the different sub -teams to ensure execution will achieve team and corporate goals (Commercial Team, Development Team, Regulatory Team etc.)
• Serving as a point of triage, the LCL facilitates clear decision-making by incorporating cross-functional input to address high-impact issues. This involves co-creating solutions to complex challenges in real time.
• The LCL leads the team in framing program needs and develops a range of options and recommendations for presentation to the Executive Leadership Team (ELT). The LCL ensures transparent communication with senior leadership, highlighting relevant scenarios, assumptions, and risks to inform decision-making and trade-offs. The LCL also represents the enterprise mindset and ensures all relevant functional perspectives have been considered.
• The LCL ensures the inclusion of subject matter experts (SMEs) and situational members in discussions, guided by a predefined agenda set with guidance from the Program Manager.
• The LCL is accountable to the ELT for program recommendations and frames them within the context of the broader portfolio.
• The LCL is accountable for day-to-day management of the program to ensure all established deliverables with high program impact remain on track and in line with program strategy.
• The LCL is responsible for ensuring the health of the team, creating a highly functional environment with collaborative ways of working where debate and honest feedback are encouraged
• Other responsibilities to consider: Risk identification and mitigation planning; ensuring financial stewardship of approved and recommended projects; clear communication throughout organization of key milestones, deliverables and progress; ensure appropriate resourcing of functions to achieve program goals and vision.

Additional Responsibilities:

• May work with Development and Commercial Teams to define the disease area strategy and to execute a business plan with clear deliverables and resource needs. This includes defining priorities and an approach to leveraging external opportunities in close collaboration with Business Development and academic experts.
• Advocates on behalf of Iovance and effectively communicates scientific/medical/clinical concepts in both written and oral communication to both internal and external stakeholders.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned. 

Required Education, Skills, and Knowledge

• Bachelor's degree in a scientific discipline; advanced or professional degree highly desirable (e.g., PhD, MD, or MBA).
• 15+ years of bio-pharmaceutical industry experience with at least 5 years of relevant work experiences in the biotech/pharmaceutical industry as a Lifecycle Leader or Program Team Leader.
• Must demonstrate strong knowledge of the overall drug development process relevant to biotech/ pharmaceutical companies; commercial launch experience and a depth of experience with drug development is required.
• Experience working with or on program strategy teams required.

Preferred Education, Skills, and Knowledge 

• Strong leadership skills from leading cross-functional teams in a matrix organization, with highly collaborative instincts and a track record of resolving conflicts within the team.
• Ability to communicate clearly and effectively with clinical scientists, biologists, manufacturing experts, as well as with regulatory and commercial colleagues at all levels of the organization.
• High degree of organizational awareness and understanding of change management and leading innovation.
• Possess significant depth and breadth of experience across phases of drug development that enable you to immediately bring considerable strategic value to a project.
• Possess understanding of drug development experience and understand what it takes to shepherd an asset through its lifecycle.

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information. 

Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines. 

Work Environment 

This job operates in a professional workplace or remote office environment and requires standard office equipment and keyboards. Employees who work remotely are expected to maintain their workspace and environment safely and free from safety hazards.

#LI-remote

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview 

The Executive Director, Regulatory Affairs is responsible for overseeing the global regulatory clinical strategy development and execution of the regulatory affairs objectives. The Executive Director oversees the development of clinical regulatory strategies for earliest possible approvals of the company’s regulatory applications at all stages of development (e.g., phase 1 through phase 4 and post launch). The Executive Director, Regulatory Affairs is responsible for tracking trends and requirements in the global market, and the impact that the changes will have on the company’s product portfolio. Addresses the analysis and evaluation of regulatory procedures and changes on the company’s products to ensure attainment of financial and strategic goals. Identifies and recommends the most effective path to regulatory approval to bring the company’s products to market in a cost-effective, compliant manner. This position oversees the evaluation and analysis of the impact of trends relative to government regulatory activities on a global basis.

Essential Functions and Responsibilities

• Supports the development and execution of global regulatory strategy for the Company’s pipeline and approved products.
• Ensures the Company maintains a strong regulatory and compliance position in all necessary jurisdictions.
• Maintains relationships with relevant regulatory agencies to improve quality of submissions and understand the impact of any pending or proposed regulatory changes.
• Lead preparations for pre- and end-of-Phase, and scientific advice regulatory agency meetings and advisory committee meetings.
• Communicate directly with regulatory authorities to expedite submissions, and their review and approval.
• Work with contract regulatory organizations to prepare applications, respond to queries, and maintain company’s development activities.
• Assure compliance with applicable regulations.
• Identify risks and interpret and communicate relevant issues to project team members and senior management.
• Educate/train company employees on regulatory matters to ensure compliance with requirements.
• Maintain knowledge of global competitive landscape, regulatory environment, and applicable regulations and guidance documents.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned. 

Required Education, Skills, and Knowledge 

• Bachelor’s Degree with 15+ years’ experience
• Or an advanced degree in the Life Sciences, an MD, PhD or PharmD, with management experience and 10+ years’ experience
• Must have cell or gene therapy experience 
• Experience with filings for oncology products 
• Knowledge of global regulations and guidance as they relate to the overall global regulatory strategy required.
• Proven ability to implement world-wide Regulatory strategies for an organization.
• Strong track record of collaborative working relationship with FDA and other key agencies worldwide which has led to successful outcomes for the business.
• Excellent verbal and written communication skills
• Ability to work within a team environment, report on projects and drive them to conclusion.
• Self-starter who works with a sense of urgency and acts as a good team player working with other disciplines.
• Adaptability, flexibility, independence and resourcefulness to roll-up-sleeves and multi-task in order to thrive in small company environment.

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information.

Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines

Work Environment

This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards. 

#LI-remote

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview

Senior Director, Clinical Data Management and Analytics, provides leadership to the Clinical Data Management and Analytics Department and provides influence across the Clinical Development organization. As a leader of the Clinical Data Management and Analytics organization, and part of a cross-functional team of drug development scientists focused on providing hands on skills, expertise, and tools to facilitate strategic development, operational execution, and regulatory compliance to ensure data integrity for clinical trials, in addition to integration, visualization, and exploratory analysis of complex and diverse data in support of clinical development activities and decisions. Through practical hands-on work, the Lead will define approaches, processes, algorithms, and tools that support the analytics, visualizations, and decision support needs of drug development scientists and projects. The Lead will play a key role in building the team with the necessary skills, build relationships with relevant stakeholders, and implement relevant tools and approaches. The Lead will collaborate with Biostatistics leads and other members of drug development teams to ensure connectivity of exploratory analysis work in support of development, regulatory approval, and market acceptance of products. This position includes functional management responsibilities.

Essential Functions and Responsibilities

• Define and implement the overall vision, strategy, and goals for the clinical data management department.
• Lead, manage, and develop data management teams, handling resource planning, staff training, and performance reviews.
• Ensure data integrity, quality, and compliance with regulatory requirements (e.g., FDA, ICH, GCPs) and internal company policies.
• Experience with global trials and regulatory submissions (FDA, EMA).
• Generate novel insights from data and present them via rich and intuitive visualizations.
• Builds successful partnerships and seamless interfaces within the department and the broader research and development organization. Communicates proactively and effectively across several teams with diverse subject matter expertise.
• Ensures quality of deliverables by consistently applying analysis and reporting standards, and driving compliance with regulatory requirements, corporate and departmental SOPs, and work practices.
• Drives the development and implementation of innovative strategies and technologies.
• Independently develops, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and build upon existing Iovance standards.
• Provides technical guidance to external partners concerning project and data standards, and analysis practices to ensure efficient and integrated project strategies.
• Identifies opportunities for increased efficiency and consistency within the organization and provides SME support to continuous improvement initiatives.
• Adheres to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Performs miscellaneous duties as assigned. 

Required Education, Skills, and Knowledge

• Extensive experience in clinical data management and systems, with proven leadership experience in oncology therapeutic area.
• Proficient knowledge of EDC systems (e.g., Medidata Rave), CDISC standards, and clinical trial processes.
• Drive innovation and continuous process improvement within data management by implementing new technologies and advanced systems to enhance productivity and efficiency.
• Demonstrated ability to lead, motivate, and develop teams.
• Excellent communication and interpersonal skills to effectively collaborate with diverse teams and stakeholders.
• Strong problem-solving and decision-making abilities to resolve complex issues and drive solutions.
• MS, BS/BA degree, or other suitable qualification with relevance to the field.
• 13 or more years’ direct experience in clinical data management in the biotechnology OR Pharmaceutical industry.
• Excellent verbal and written communication skills and strong interpersonal skills are required.
• Demonstrated ability to develop and lead a team of individuals with diverse experience and expertise.
• Ability to explain technically complex information for a non-technical audience.
• Strong positive attitude, thrives in a dynamic, fast paced environment with many simultaneous projects.
• Demonstrates the ability to work within budget constraints, while utilizing resources efficiently and in a fiscally responsible manner.

Preferred Education, Skills, and Knowledge

• Experience with AI applications in the data management space is highly desirable.

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information.

Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.

Work Environment

This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards. 

#LI-remote

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview

As Iovance prepares to bring AMTAGVI® to patients globally outside the United States, we are seeking an individual who is experienced with HTA, Evidence, and Global Access. This role will be a critical contributor to Iovance’s HTA, evidence, and global access strategies and will report to the Senior Director, Global Market Access. The position is responsible for supporting international markets where Iovance is pursuing reimbursement, planning for new indication and products, and support of commercial activities generally. Core responsibilities include end-to-end management of health technology assessment (HTA) submissions, developing Iovance’s evidence generation activities, engagement with HTA bodies and payers, development of global value and access materials, and project management across global market access and HEOR activities. The role will also support HEOR-related activities —including research, economic modeling, and publications – and may from time to time engage in activities supporting projects from regulatory, commercial, or other teams. The Director will serve as the internal subject matter expert for HTA, access, and evidence generation in priority markets, and maintains a strong understanding of evolving health policies and reimbursement environments while building and sustaining relationships with key external stakeholders. Prior experience in oncology, rare diseases, and/or advanced therapy medicinal products (ATMPs) is highly desirable. The ideal candidate is highly organized, detail-oriented, proactive, and solutions-focused, with strong analytical and problem-solving skills.

The level of this role will be aligned to the individual’s experience, competencies, and demonstrated ability relative to the requirements of the position.

Essential Functions and Responsibilities

• 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.

Preferred Education, Skills, and Knowledge

• 12+ years of relevant experience in the biopharmaceutical industry, with demonstrated expertise in health economics, outcomes research, market access, real world evidence and/or related functions.
• Strong background in oncology, cell therapy, ATMPs, and/or rare diseases preferred.
• Advanced degree preferred in a field related to HEOR (health economics, epidemiology, health services research or similar), or a medical field.
• Experience and ability in developing strategic analyses and plans
• Strong understanding of scientific, clinical, and real-world evidence, with the ability to communicate complex concepts clearly.
• Excellent written and verbal communication skills, including significant experience presenting to executive-level audiences.
• Highly organized with excellent project management skills
• Deep understanding of international healthcare systems, including HTA processes, reimbursement frameworks, and health policy considerations across global markets.
• Fluency in French or German would be an asset.

Physical Demands and Activities Required

The physical demands described here represent those an employee may encounter while performing the essential functions of this job. Reasonable accommodation may be provided to enable individuals to perform these functions.

• Ability to remain in a stationary position for extended periods
• Ability to move about within an office or remote workspace and exert up to 10 pounds of force occasionally
• Visual acuity sufficient for preparing and analyzing data, viewing computer screens, and extensive reading
• Repetitive motion involving wrists, hands, and/or fingers
• Ability to communicate effectively to exchange information
• Cognitive: Ability to engage in analytical, conceptual, and problem‑solving activities in a dynamic business environment

Work Environment

This role operates in a professional office or remote work environment and requires routine use of standard office equipment and technology. Employees working remotely are expected to maintain a safe workspace free from recognized hazards.

Equal Employment Opportunity

#li-remote

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview

The Director Community Strategy is accountable for advancing commercial growth objectives by developing and executing community-focused strategies that strengthen referral pathways, and support adoption across the oncology ecosystem.

This role translates enterprise priorities into community-aligned initiatives involving community oncology practices, Authorized Treatment Centers (ATCs), professional organizations, and advocacy stakeholders.

Working within a highly matrixed environment, the Director collaborates cross-functionally to ensure community insights, partnerships, and executional initiatives are aligned with, and complementary to, access and brand strategies, while maintaining a strong focus on execution, partnership activation, and performance tracking.

Essential Functions and Responsibilities:

Community Strategy & Execution

• Develop and own a strategic community engagement plan that supports commercial, access, and brand objectives
• Lead development and execution of referral pathway strategies between ATCs and affiliated community practices, leveraging EMR and data‑enabled capabilities
• Identify and prioritize opportunities to expand disease and therapy education through ATC and community oncology partnerships
• Translate community insights into actionable recommendations that inform enterprise strategy and execution

Strategic Partnership & Alignment

• Partner closely with Market Access to ensure community initiatives support access strategies while avoiding duplication of ownership

• Collaborate with brand and pre‑market teams to align community efforts with brand priorities and launch/readiness milestones
• Lead and influence strategic planning processes through insight generation, analysis, and recommendations that inform enterprise decisions
• Provide community expertise to customer segmentation and engagement planning efforts
• Enable and educate internal stakeholders on community strategy priorities, frameworks, and initiatives
• Partner with field‑based teams to drive consistent, compliant execution of community programs across geographies

Community Partnerships & External Engagement

• Co‑lead strategic relationships with community oncology networks, professional societies, and healthcare organizations (e.g., COA, ACCC, NCODA)
• Identify, assess, and prioritize external partnership opportunities aligned with enterprise objectives
• Define objectives, success metrics, and track KPIs to measure performance and impact of community collaborations

Operational & Compliance Responsibilities

• Oversee contracting, administrative processes, and budget management for community initiatives
• Develop clear, impactful, and cross‑functionally aligned executive‑level presentations, requiring advanced proficiency in PowerPoint and SharePoint
• Ensure all activities are conducted in compliance with corporate policies, business ethics standards, and applicable healthcare regulations
• Expected to adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.

Travel – Approximately 40% of the time as business need

Required Education, Skills, and Knowledge

• Bachelor’s degree required; advanced degree (MBA, MPH, PharmD, PhD) preferred
• 8–10+ years of biopharmaceutical experience in commercial, marketing, or strategy roles
• 5+ years of oncology and/or cell therapy commercial experience strongly preferred
• Experience working with community oncology stakeholders, ATCs, health systems, and large practices
• Strong understanding of referral dynamics, inpatient/outpatient oncology pathways, and cell therapy infrastructure
• Demonstrated ability to work effectively in matrixed, fast-paced environments
• Strong communication skills with experience developing executive-ready materials

Physical Demands and Activities Required

The physical demands described here represent those an employee may encounter while performing the essential functions of this job. Reasonable accommodation may be provided to enable individuals to perform these functions.

• Ability to remain in a stationary position for extended periods
• Ability to move about within an office or remote workspace and exert up to 10 pounds of force occasionally
• Visual acuity sufficient for preparing and analyzing data, viewing computer screens, and extensive reading
• Repetitive motion involving wrists, hands, and/or fingers
• Ability to communicate effectively to exchange information
• Cognitive: Ability to engage in analytical, conceptual, and problem‑solving activities in a dynamic business environment

Work Environment

This role operates in a professional office or remote work environment and requires routine use of standard office equipment and technology. Employees working remotely are expected to maintain a safe workspace free from recognized hazards.

#li-remote

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview

The Medical Affairs Associate supports the execution of U.S. Medical Affairs strategy by providing cross-functional coordination, scientific/medical information support, and operational execution across key Medical Affairs activities (e.g., medical information processes, scientific communications, publications support, and field medical support). This role helps ensure timely, accurate, and compliant delivery of medical deliverables in partnership with Medical Affairs, Commercial, Legal/Compliance, and other cross-functional teams.

Under the guidance of senior Medical Affairs colleagues and in alignment with company policies and applicable laws and regulations, the Associate assists with the intake, documentation, and coordination of responses to unsolicited requests for medical/scientific information.

 Essential Functions and Responsibilities

• Independently plan and coordinate components of Medical Affairs initiatives (e.g., scientific exchange programs, internal medical education) by defining timelines, aligning stakeholders, and tracking deliverables to completion
• Draft, revise, and quality-check scientific/medical materials (e.g., slide decks, FAQs, standard response documents) by applying approved source content and exercising judgment to ensure accuracy, clarity, and compliance with internal review requirements
• Serve as a cross-functional point of contact for assigned workstreams by synthesizing input from Medical Information, Publications, Medical Communications, Field Medical, and other partners to drive consistent execution
• Analyze and summarize medical/scientific insights and relevant literature using approved tools; identify trends, develop implications for the team, and communicate findings to appropriate stakeholders
• Support scientific congress strategy execution by coordinating deliverables, maintaining trackers, and preparing post-congress summaries (e.g., key data takeaways and action items) for internal use
• Partner with Legal/Compliance and other cross-functional teams to ensure activities follow policy (including appropriate handling of unsolicited requests, privacy, safety reporting, and documentation standards); escalate issues and recommend next steps
• Maintain ownership of assigned operational processes (e.g., document/version control, meeting cadence, action-item management) and recommend process improvements to enhance quality, efficiency, and audit readiness
• Exercise independent judgment to prioritize competing requests, evaluate risks/impacts, and communicate options and recommendations to leaders to support timely decisions
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics
• Other duties as assigned

Travel

• Up to 20% travel, as needed, for scientific congresses and internal meetings.

Required Education, Skills, and Knowledge

• Advanced degree preferred (PharmD, PhD, MD, or MS in life sciences)
• Bachelor’s degree with relevant experience will be considered
• or equivalent combination of education and experience
• Ability to communicate scientific/medical information clearly to varied audiences (written and verbal)
• 0–2 years of relevant experience (e.g., internships or roles in Medical Affairs, Medical Information, clinical research, healthcare, scientific communications, or related areas)
• Demonstrated skills or ability to develop skills in the following areas: decision-making, collaboration, planning and organizing, follow-through, attention to detail, and written/verbal communication
• High attention to detail with strong project management capabilities
• Meeting management skills and operational capabilities
• Ability to manage multiple priorities and meet agreed‑upon deadlines in a dynamic environment
• Ability to work effectively within a matrix organization to achieve desired outcomes

Preferred Education, Skills, and Knowledge

• Familiarity with Medical Affairs and Medical Information processes in the biopharma/healthcare industry
• Familiarity with compliance considerations relevant to Medical Affairs (e.g., unsolicited requests, approved use, privacy, documentation standards)
• Comfort presenting or summarizing information to internal audiences (e.g., team updates, project readouts)
• Experience coordinating across functions and maintaining organized documentation (e.g., trackers, meeting notes, version control)
• Strong interest in developing scientific/medical writing and analytics skills (e.g., literature review, Excel, PowerPoint)

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodation may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request accommodation.

Physical Demands and Activities Required

• Ability to travel within the U.S., as required.
• Ability to remain in a stationary position (sitting or standing) for prolonged periods.
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to perform activities such as preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information.

Mental: Ability to apply clear and conceptual thinking; exercise sound judgment; analyze information; maintain discretion with confidential data; manage multiple priorities; and meet deadlines

Work Environment

This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards, which will be provided. 

#li-remote

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview

The Sr. Manager, Protein Sciences (Upstream) is an experienced manufacturing and processing subject matter expert responsible for managing Iovance’s GMP manufacturing operations and contracted manufacturing operations centered on protein production and characterization, with a focus on upstream process. S/He will actively collaborate with Process Development, Analytical Development,  Manufacturing, Quality Control, Quality, Supply Chain, and Regulatory functions, with a focus on ex-US manufacturing operations.

This position will report to the head of Protein Sciences, and involves planning, coordinating, and overseeing contract manufacturing and development services for Iovance products through the product life cycle. Activities requiring oversight include process development, transfer, scaleup, validation, improvements (COGS), and studies supporting technical changes/improvements. This position will also provide necessary leadership to support CMC product teams and/or lead subteams, manage technical information/data flows, manage project milestones, support audits, and assist in qualification, validation, and regulatory filing activities. Additionally, this position will be responsible for manufacturing data management for selected clinical/commercial products.  

Responsibilities

• Subject matter expert in diverse molecular biology, protein expression, and biochemistry. An understanding of analytical methods is preferred.
• Manage and/or support knowledge management (including product, process, and analytical)
• Manage and/or support process, analytical, microbial control strategy development and implementation, and risk assessment and mitigation.
• Build and support long term business relationships with key Contract Manufacturing Organizations in support of flexible and efficient supply chains.
• Manage and/or support technical transfer and technical/COGS improvement projects. Ensure effective stakeholder engagement and ensure on-time and in-budget delivery.
• Support regulatory CMC and registrational activities for clinical/commercial products as required, with a focus on ex-US.
• Liaise with Quality/Supply Chain on product disposition and ensure continuous alignment with quality/supply chain systems requirements. Support technical investigations, deviations and CAPAs as required. Support and participate in site audits, as required.
• Manage and/or support hiring and development of staff, as required.
• Ensure CMO site operational readiness for manufacturing campaigns/process transfer/change controls/validations; including facilities, equipment, documentation, training.
• Utilize strong operational excellence / lean principles, business acumen, quality-mindedness, and excellent communication skills to develop streamlined, efficient, and robust systems.

Required Experience

• A minimum of 9 years of related experience with a Bachelor's degree; or 7 years and a Master's degree; or a PhD with 4 years experience in a relevant Life Science discipline or equivalent in work experience.
• In-depth understanding of protein expression and characterization. Good understanding of purification and QC methods is a plus.
• Strong prior operational experience preferably in a direct role in a GMP manufacturing environment, with interfaces to Supply Chain, Quality and Regulatory functions, with commensurate experience supporting internationally licensed products.
• Direct experience managing contract development/manufacturing organizations (CDMOs), with focus on aseptic operations and commercial manufacturing, is preferred.
• Must possess a thorough understanding of biotherapeutics manufacturing.
• Demonstrated business and commercial focus with awareness of customer/patient-centric issues.
• Experience working in a global business environment across multiple time zones.
• Self-starter, possessing strong verbal and written communication skills.
• Ability/willingness to travel globally for extended periods, based on business needs.

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to work on a tablet or computer for 80% of a typical working day.
• Must be able to move and lift 15 pounds.
• Wear proper personal protective equipment when in the warehouse, laboratory setting, i.e., safety glasses, lab coats, and closed-toed shoes.

Mental

• Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion.
• Ability to handle work-related stress.
• Ability to handle multiple priorities simultaneously.
• Ability to meet deadlines.

Work Environment

• This position will work in both an office and a manufacturing setting.
• Potential exposure to noise, equipment hazards and strong odors.

#LI-onsite

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview

The Sr. Manager, Protein Sciences (Downstream) is an experienced manufacturing and processing subject matter expert responsible for managing Iovance’s GMP manufacturing operations and contracted manufacturing operations centered on protein production and characterization, with a focus on downstream process, including drug product formulation, fill, and lyophilization. S/He will actively collaborate with Process Development, Analytical Development,  Manufacturing, Quality Control, Quality, Supply Chain, and Regulatory functions, with a focus on ex-US manufacturing operations.

This position will report to the head of Protein Sciences, and involves planning, coordinating, and overseeing contract manufacturing and development services for Iovance products through the product life cycle. Oversight includes process development, transfer, scaleup, validation, improvements (COGS), and studies supporting technical changes/improvements. This position will also provide necessary leadership to support CMC product teams and/or lead subteams, manage technical information/data flows, manage project milestones, support audits, and assist in qualification, validation, and regulatory filing activities. Additionally, this position will be responsible for manufacturing data management for selected clinical/commercial products.  

Responsibilities

• Subject matter expert in protein purification, drug product formulation, fill, and lyophilization.
• Manage and/or support knowledge management (including product, process, and analytical)
• Manage and/or support process, analytical, microbial control strategy development and implementation, and risk assessment and mitigation.
• Build and support long term business relationships with key Contract Manufacturing Organizations in support of flexible and efficient supply chains.
• Manage and/or support technical transfer and technical/COGS improvement projects. Ensure effective stakeholder engagement and ensure on-time and in-budget delivery.
• Support regulatory CMC and registrational activities for clinical/commercial products as required, with a focus on ex-US.
• Liaise with Quality/Supply Chain on product disposition and ensure continuous alignment with quality/supply chain systems requirements. Support technical investigations, deviations and CAPAs as required. Support and participate in site audits, as required.
• Manage and/or support hiring and development of staff, as required.
• Ensure CMO site operational readiness for manufacturing campaigns/process transfer/change controls/validations; including facilities, equipment, documentation, training.
• Utilize strong operational excellence / lean principles, business acumen, quality-mindedness, and excellent communication skills to develop streamlined, efficient, and robust systems.

Required Experience

• A minimum of 9 years of related experience with a Bachelor's degree; or 7 years and a Master's degree; or a PhD with 4 years experience in a relevant Life Science discipline or equivalent in work experience.
• In-depth understanding of protein purification, characterization, drug product formulation, fill and lyophilization. Good understanding of protein expression, cell culture processing, and QC methods is a plus.
• Strong prior operational experience preferably in a direct role in a GMP manufacturing environment, with interfaces to Supply Chain, Quality and Regulatory functions, with commensurate experience supporting internationally licensed products.
• Direct experience managing contract development/manufacturing organizations (CDMOs), with focus on aseptic operations and commercial manufacturing, is preferred.
• Must possess a thorough understanding of biotherapeutics manufacturing.
• Demonstrated business and commercial focus with awareness of customer/patient-centric issues.
• Experience working in a global business environment across multiple time zones.
• Self-starter, possessing strong verbal and written communication skills.
• Ability/willingness to travel globally for extended periods, based on business needs.

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to work on a tablet or computer for 80% of a typical working day.
• Must be able to move and lift 15 pounds.
• Wear proper personal protective equipment when in the warehouse, laboratory setting, i.e., safety glasses, lab coats, and closed-toed shoes.

Mental

• Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion.
• Ability to handle work-related stress.
• Ability to handle multiple priorities simultaneously.
• Ability to meet deadlines.

Work Environment

• This position will work in both an office and a manufacturing setting.
• Potential exposure to noise, equipment hazards and strong odors.

#LI-onsite

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview

The Senior Clinical Trial Manager (CTM) in the Research Alliances team will independently lead and is accountable for the planning, execution, management, and reporting of clinical projects supporting Iovance commercial activities, including Expanded Access Programs (intermediate EAP, single-patient and Ex-US Access Programs) and Phase 4 post marketing studies.  In addition, the Sr. CTM/CTM will provide operational leadership for studies within a growing portfolio of Investigator Sponsored collaborations and other non-clinical collaborative research initiatives involving lifileucel and Proleukin. This position works very closely with external vendors, HCPs, as well as multiple Iovance teams: Commercial, Medical Affairs, Regulatory, Safety, Clinical, Biometrics, Quality, Legal, Quality, Supply Chain & Logistics and Manufacturing. 

The ideal candidate will have clinical operations experience within the pharma/biotech arena, be self-motivated, and able demonstrate the ability to manage complex programs independently while collaborating effectively in a dynamic, agile, and evolving organization.

Essential Functions and Responsibilities

• Oversee the timely activation, execution, and management of Expanded Access Programs (EAPs) that support commercial launch activities at authorized treatment centers 
• Leads the activities for the timely activation, execution, and management of Post Marketing study
• Oversee the timely activation, execution, and management of ISTs/non-clinical research projects
• Ensure Sunshine Act reporting data for lifileucel and Proleukin products across Research Alliances programs are collected
• Works closely with Legal to initiate CDAs, clinical trial and service agreements, amendments and change orders for EAPs, Phase 4, Investigator-Sponsored and non-clinical collaborations.
• Manages external contract research organizations involved with EAPs and Phase 4 who will have responsibility for site interaction, site monitoring, patient schedule management, data collection/management, central IRB interaction, and clinical site contracts.
• Oversee drug supplies, co-therapies, and lab supplies for clinical and non-clinical collaboration studies and EAPs.
• Reports to Iovance teams on study status, activity and site/vendor performance. Develops and maintains dashboards and trackers to communicate progress and risks.
• Ensure that Investigative sites submit monthly enrollment logs, safety listings, database transfers and quarterly reports or as required in the study agreements.
• Responsible for the writing and updating workflows, manuals, consent forms, and technical documents to support EAPs, Phase 4, ISTs/collaborations and non-clinical studies.
• Organizes and documents decisions of routine meetings with internal teams, CROs and Investigator/research teams.
• Collect and maintain essential regulatory documents.
• Contribute and lead process improvements by updating or developing SOPs and Work Instructions.  
• Performs additional job-related duties as required to support successful program execution.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform other miscellaneous duties as assigned. 

Travel - 15% of the time.

Required Education, Skills, and Knowledge

• Bachelor’s degree in health or science-related area with 7+ (Sr. CTM) or 5+ (CTM) years of clinical operations experience in the pharmaceutical or biotech area. Or an equivalent combination of education and relevant experience
• Demonstrated ability to independently initiate and manage Expanded Access Programs and Phase 1–4 clinical trials
• Proven track record of building and maintaining effective relationships with investigative sites and site personnel
• Excellent written and verbal communication skills, with the ability to collaborate across internal and external stakeholders
• Demonstrated ability to work independently, adapt to changing priorities, and manage multiple programs in a dynamic, result-driven environment
• Knowledge of US and Global Regulations and Guidance (ICH-GCP, FDA-CFR)
• Experience in data collection, review and monitoring Phase 1-4 clinical studies
• Demonstrated experience leading phase 1-4 clinical trials and supporting ISTs.
• Demonstrated success in managing clinical studies within timeline and budget.
• Strong interpersonal communication (verbal and written) with the ability to build strong relationships with peers and partners within and across functional teams to engage in high performance.
• In-depth knowledge of Microsoft Office, including MS Word, MS Excel, MS PowerPoint, and MS Outlook
• Previous experience with EDC systems (eClinical, Medidata RAVE, InForm), and electronic Trial Master File systems
• Requires working knowledge of Good Clinical Practices, Food and Drug Administration regulatory reporting requirements, and the regulations and laws governing the pharmaceutical industry (e.g., compliance, Sunshine Act)

Preferred Education, Skills, and Knowledge 

• Oncology/immunotherapy experience
• Phase 4, Expanded Access Program experience

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodation may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request accommodation.

The physical demands described here represent those an employee may encounter while performing the essential functions of this job. Reasonable accommodation may be provided to enable individuals to perform these functions.

• Ability to remain in a stationary position for extended periods
• Ability to move about within an office or remote workspace and exert up to 10 pounds of force occasionally
• Visual acuity sufficient for preparing and analyzing data, viewing computer screens, and extensive reading
• Repetitive motion involving wrists, hands, and/or fingers
• Ability to communicate effectively to exchange information
• Cognitive: Ability to engage in analytical, conceptual, and problem‑solving activities in a dynamic business environment 

Work Environment

This role operates in a professional office or remote work environment and requires routine use of standard office equipment and technology. Employees working remotely are expected to maintain a safe workspace free from recognized hazards.

#LI-remote

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview

The Executive Director, Forecasting and Portfolio Analytics will serve as the enterprise lead for commercial forecasting, portfolio analytics, and decision support at Iovance Biotherapeutics. As a core member of the Business Analytics & Insights Leadership team, this role is accountable for delivering high‑quality near‑term and long‑term global forecasts, scenario analyses, and enterprise insights that inform commercial strategy, investment decisions, and long‑range planning and governance discussions with Executive Leadership and the Board of Directors.

This is a highly hands-on leadership role requiring deep technical expertise and direct ownership of forecasting and analytical work. The Executive Director is expected to be accountable for the design, build and stewardship of core forecasting models and decision-support analyses, ensuring rigorous assumptions, transparency, and confidence in outputs. External partners may be leveraged selectively for supplemental support, but this role retains clear internal ownership and execution responsibility for all critical forecasting and analytics deliverables.

This position supports the ongoing commercialization of AMTAGVI® and Proleukin®, as well as global launch planning for new indications, new markets, and Iovance’s expanding portfolio of innovative cell therapies.

The role requires deep expertise in forecasting and analytics, strong cross functional leadership, and the ability to operate effectively in a dynamic, results‑oriented biotech environment.

The role reports to the Vice President, Global Commercial Operations and partners closely with senior leaders across Commercial, Finance, Manufacturing, Market Access, Medical Affairs, Clinical Operations, and Executive Leadership.

Essential Functions and Responsibilities

Forecasting & Commercial Analytics

• Own and deliver global commercial forecasts across marketed and pipeline assets, including U.S. and international markets.
• Directly develop, build, and maintain revenue forecasting, demand planning, and capacity models, incorporating treatment center dynamics, manufacturing constraints, access considerations, and market development assumptions.
• Design and refine forecasting methodologies, assumptions, and scenario-based models to support annual operating plans, long-range planning, and investment decisions.
• Ensure forecast integrity, transparency, and alignment across Commercial, Finance, Manufacturing, Supply Chain, and Executive Leadership.
• Serve as the primary internal expert on forecast logic, assumptions, sensitivities, and risks.
• Establish and steward enterprise‑wide forecasting standards, governance frameworks, and operating processes to ensure consistency, scalability, and audit‑ready transparency.

Strategic Decision Support

• Provide enterprise level decision support, including scenario planning, opportunity assessments, indication sequencing, and portfolio prioritization.
• Translate complex data into clear, actionable insights and strategic recommendations for Executive Leadership and the Board of Directors.
• Support pricing, access, and reimbursement strategy development through evidence‑based modeling and analytics.
• Play a critical role in global launch planning, supporting readiness, phasing, and market expansion decisions.

Cross Functional Leadership & Partnership

• Act as a strategic thought partner to Commercial, Finance, Business Development, Market Access, Medical Affairs, Clinical Operations, and Manufacturing.
• Identify, evaluate, and integrate primary and secondary data sources to address key strategic and operational questions.
• Collaborate effectively across functions to align forecasts with operational realities and commercial objectives and influence enterprise‑level prioritization and resource allocation decisions.
• Build credibility through deep command of the data, assumptions, and analytical frameworks underpinning recommendations.

Team & Capability Development

• Build, lead, and develop a high-performing forecasting and analytics team, setting clear expectations for analytical rigor, internal ownership, and execution excellence.
• Establish best practices, tools, and processes to continuously enhance forecasting accuracy and analytical rigor and organizational impact.
• Manage external vendors and partners as supplemental resources, ensuring that all core forecasting methodologies, models, and strategic analyses are developed, owned, and understood internally.

Additional Responsibilities

• Contribute broadly to commercial excellence initiatives and perform other duties as assigned in support of company objectives.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.

Travel - Up to 20% (domestic and international). 

Required Education, Skills, and Knowledge 

• Bachelor’s degree required; master’s degree in business, analytics, economics, statistics, or life sciences preferred, or an equivalent combination of education and experience. or an equivalent combination of education and demonstrated experience.
• 12+ years of experience in the biopharmaceutical or related industry, including 8+ years of progressive responsibility in commercial forecasting, analytics, or decision support. Or equivalent experience demonstrating the scope and impact required at the executive director’s level.
• Demonstrated experience supporting U.S. marketed products; oncology experience strongly preferred.
• Proven launch experience; cell therapy or specialty oncology experience highly desirable.
• Broad expertise across forecasting, market research, secondary data analysis, and advanced analytics.
• Experience managing complex initiatives involving senior stakeholders, budgets, timelines, and external vendors.
• Exceptional analytical, critical thinking, and strategic problem‑solving capabilities. 
• Ability to communicate complex analytical concepts clearly and effectively to diverse executive and stakeholder audiences.
• Demonstrated ability to influence senior leaders and drive data-based decision‑making. 
• Proven track record of translating strategy into execution in a fast paced, evolving commercial environment. 
• Collaborative, solutions-oriented leader who builds credibility across functions and with external partners. 
• Agile, resilient, and able to operate effectively amid ambiguity, growth, and change. 

Physical Demands and Activities Required

The physical demands described here represent those an employee may encounter while performing the essential functions of this job. Reasonable accommodation may be provided to enable individuals to perform these functions.

• Ability to remain in a stationary position for extended periods
• Ability to move about within an office or remote workspace and exert up to 10 pounds of force occasionally
• Visual acuity sufficient for preparing and analyzing data, viewing computer screens, and extensive reading
• Repetitive motion involving wrists, hands, and/or fingers
• Ability to communicate effectively to exchange information
• Cognitive: Ability to engage in analytical, conceptual, and problem‑solving activities in a dynamic business environment

Work Environment

This role operates in a professional office or remote work environment and requires routine use of standard office equipment and technology. Employees working remotely are expected to maintain a safe workspace free from recognized hazards.

#LI-remote

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview
The Associate ATC Operations Liaison will provide operational and clinical information on establishing TIL as the standard of care to physicians and other healthcare providers. The Associate ATC Operations Liaison will lead the authorization activities of commercial centers and provide operational, quality, and clinical oversite post-launch.  The Associate ATC Operations Liaison will also identify and develop relationships with Treatment Center’s physicians, nursing, lab, pharmacy, and quality personnel. The successful candidate will have experience working in the cellular therapy field at a treatment center by working within operations, quality, the cell lab, or nursing and bringing practical knowledge and skills as they interact with external teams (physicians, surgeons, nurses, administrators, quality personnel) and work collaboratively with cross-functional internal teams. Understanding the environment and influences impacting the treatment centers’ providers and personnel.

Essential Functions and Responsibilities

• Develop and maintain relationships with key stakeholders from the treatment center responsible for establishing the TIL service line.
• Responsible for the operational oversight of authorized treatment centers in the assigned region.
• Lead operational meetings with the physician leadership from Medical Oncology, Surgery, and Cell Therapy to establish a standard of care pathway for TIL
• Lead cross-functional meetings with the nursing, laboratory, pharmacists, quality, and operational champions to develop the product and patient workflows for TIL
• SME to develop or review operating Procedures (SOPs) required for Treatment Centers to order TIL
• Develop and prioritize solutions to operational barriers; understanding the needs of the authorized treatment centers
• Operational Oversight of the tumor tissue procurement workflow, final product receipt, storage and distribution, and TIL infusion.
• Assess and approve any changes to the collection, courier tracking, order intake, and order processing systems to ensure the validated state of the systems is maintained.
• Lead the TIL center authorization process using risk-based tools for authorization, training, monitoring, and disqualification.
• Develop and execute training of authorized users.  Ensure access to COI/COC is provided to trained individuals.
• Oversee the Chain of Identity and Chain of Custody at the Treatment Center.
• Respond to every detour from the established lifileucel standard of care pathway and commit to responding with the utmost experience and collegiality
• Support and/or own quality records (Deviations, CAPA, Change control, etc.)
• Participate in advisory board meetings to gain insight into future educational needs.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned. 

Required Education, Skills, and Knowledge 

• Master’s degree in clinical field or healthcare administration with 7+ years of experience or Bachelor's degree with 9+ years of experience.
• 7+ years of progressive experience in a medical or pharmaceutical environment, including nursing, surgical oncology, and transplant/infusion centers preferred.
• Competence in the following areas: Needs Assessment, Facilitation, Prioritization, Decision Making, Collaboration, Planning & Organizing, Implementation/Follow-up, Written and Verbal Communication.
• Demonstrated ability to present compelling and influential oral presentations.
• Management skills and operational capabilities.
• Ability to perform under pressure and meet deadlines.
• Ability to work effectively within a matrix organization to achieve desired outcomes.

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodation may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request accommodation.

Physical Demands and Activities Required

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information.
• Ability to travel 50%

Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to manage multiple priorities simultaneously; and ability to meet deadlines. 

Work Environment

This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards. 

#LI-remote