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

Pulmovant is a Roivant-backed clinical-stage biotechnology company developing innovative therapies for patients suffering from pulmonary diseases. Pulmovant’s first program, mosliciguat is designed to provide an effective, once-daily, inhaled treatment option for patients with pulmonary hypertension (PH). Mosliciguat is a novel, potential first-in-class, sGC activator with a differentiated mechanism that may have broad applicability across the PH spectrum.

Mosliciguat has been extensively characterized across a robust Phase 1 program with 170 participants dosed to date including patients with PH in the Phase 1b ATMOS study which has produced highly compelling and clinically meaningful efficacy data, as well as a favorable safety profile. Pulmovant recently completed enrollment in the Phase 2 PHocus study evaluating mosliciguat in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD), with topline data expected in the second half of 2026. Mosliciguat is also being evaluated in the Phase 2 PHactor study in combination with inhaled treprostinil in patients with PH-ILD.

As part of the Roivant family of companies, Pulmovant leverages the power of collaboration and innovation to drive progress.

For more information, please visit https://www.pulmovant.com.

About Roivant:

Roivant specializes in developing transformative medicines at an accelerated pace through the launch of nimble biopharmaceutical and health technology entities, each meticulously tailored to address a specific medical need. Since its inception in 2014, Roivant has achieved the following critical milestones in support of its vision: built over 20 Vants; 12 consecutive positive Phase 3 trials; 8 FDA approvals; 5 successful IPOs; >$6B in capital raised; >$10B in global pharma partnerships and proceeds; and continued pipeline expansion across various modalities and therapeutic areas through in-licensing and acquisition of novel product candidates and technology platforms.  In addition to a robust clinical stage pipeline, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business.

Position: Senior Director / Head of Biometrics

Summary:

Pulmovant is seeking an accomplished biostatistician to lead the Biometrics function. This individual will own and build the Biostatistics and Statistical Programming functions, providing strategic and operational leadership across all of Pulmovant’s clinical development programs.

This is a high-impact opportunity at a pivotal moment for the company. With enrollment recently completed in the Phase 2 PHocus study of mosliciguat in PH-ILD and topline results expected in the second half of 2026, the Head of Biometrics will play a critical role in shaping the analysis, regulatory strategy, and registrational path for a potential first-in-class inhaled sGC activator. The successful candidate will partner closely with Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, and external CROs to deliver high-quality, regulatory-grade biometrics deliverables and to scale a fit-for-purpose function as the pipeline advances.

Key Duties and Responsibilities 

• Lead, build, and oversee the Biostatistics and Statistical Programming functions, establishing standards, processes, and infrastructure to support a growing pipeline.
• Serve as the senior biostatistical leader across Pulmovant’s programs, including the Phase 2 PHocus and PHactor studies of mosliciguat in PH-ILD, and future late-stage and registrational studies.
• Provide strategic statistical input into protocol design, sample size justification, statistical analysis plans (SAPs), and integrated analyses (ISS/ISE) supporting regulatory submissions.
• Review data quality, completeness, and key derivations
• Review and provide feedback and QC on TLF shells and outputs
• Ensure deliverables meet SAP specifications and quality standards
• Confirm readiness of TLR package for internal/external use
• Partner with Clinical Development, Regulatory Affairs, and Clinical Operations to define endpoints, estimands, and analysis strategies aligned with FDA, EMA, and other global health authority expectations.
• Oversee CRO biostatistics and statistical programming deliverables, ensuring quality, timeliness, and adherence to CDISC (SDTM/ADaM), FDA, and ICH E9/E9(R1) standards.
• Lead preparation of biometrics components of regulatory submissions (IND, EOP2, NDA/MAA) and represent Pulmovant in interactions with FDA and other agencies.
• Drive innovative analytical approaches, including adaptive designs, Bayesian methods, and use of historical or external controls where appropriate for a rare-disease setting.
• Build and lead a high-performing team of biostatisticians and statistical programmers; mentor staff and shape the talent strategy as Pulmovant scales.
• Support data monitoring committees (DMCs), trial steering committees, and key opinion leader engagements.
• Contribute to publications, scientific communications, and conference presentations of clinical trial results.

Education and Experience 

• PhD in Biostatistics, Statistics, or a closely related quantitative field (MS with extensive industry experience may be considered).
• 12+ years (Senior Director) or 15+ years (Vice President) of biostatistics experience in the biopharmaceutical industry, including significant time leading biostatistics across late-stage development and regulatory submissions.
• Demonstrated experience leading both Biostatistics and Statistical Programming functions, including oversight of CRO partners.
• Track record of leading biostatistical strategy through successful regulatory interactions and submissions (IND, NDA/BLA, MAA); FDA submission experience required.
• Prior experience in pulmonary, cardiovascular, rare disease, or interstitial lung disease therapeutic areas is strongly preferred; experience with PH or PH-ILD a plus.
• Experience working in a small or mid-cap biotech and operating effectively in a lean, fast-paced environment.

Essential Skills and Abilities 

• Deep expertise in statistical methodology for clinical trials, including adaptive designs, longitudinal/mixed models, survival analysis, missing data, and estimands per ICH E9(R1).
• Working knowledge of statistical programming in SAS and R; expert understanding of CDISC (SDTM, ADaM) standards and submission deliverables.
• Strong regulatory acumen and ability to translate complex statistical concepts into clear narratives for regulators, executives, and clinical partners.
• Proven leadership and people-management skills; ability to attract, develop, and retain top biometrics talent.
• Excellent written and verbal communication skills, with comfort presenting to executives, regulators, DMCs, and external KOLs.
• Strategic mindset paired with a hands-on willingness to operate at all levels in a small-company setting.
• Strong cross-functional collaboration skills with Clinical Development, Clinical Operations, Data Management, Regulatory, and Medical Affairs.
• Proficient in vendor and CRO management, with proven ability to drive quality and timelines.
• High personal integrity, scientific rigor, and unwavering commitment to patients.

Pulmovant provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

We will not accept unsolicited resumes nor outreach from agencies. Please do not send agency resumes to our website or Roivant Sciences and affiliated employees. Thanks!

Reports To: Head of Global Medical Operations

About This Role:

The Associate Director, Global Medical Operations provides operational oversight within Global Medical Affairs and partners closely with global and regional medical teams. This role supports the planning and execution of key medical activities, including global advisory boards, global congress activities, medical insights infrastructure, grants and giving governance, external expert engagement, digital medical solutions, and key internal medical meetings. 

This is a hands-on, execution focused role that ensures seamless coordination and high-quality delivery across Medical Operations. We’re looking for a collaborative, adaptable professional who thrives in a fast paced, emerging biotech environment—someone who can juggle priorities, pivot quickly, and build strong cross functional relationships. 

What You'll Do: 

• Lead planning and execution of Global Advisory Boards, with support from a local vendor and in collaboration with Legal/Compliance, ensuring compliant business needs assessment review, logistics coordination, cross border regulatory requirements, contracting, FMV alignment, and final insights documentation
• Partner with Global Scientific Communications to oversee end-to-end global congress logistics—including booth operations, symposia support, onsite coordination, and operational deliverables—across an annual schedule of 3–4 global congresses.
• Partner with IT to manage the global insights process and digital framework, enabling structured insights capture, analysis, dashboard reporting, and cross functional dissemination across all regions to support global strategy development. 
• Support Global Grants & Giving governance, including review workflows, due diligence documentation, and compliance alignment. 
• Provide operational support for External Expert Engagement, in collaboration with Legal/Compliance, ensuring FMV standards, compliant contracting, and tracking of local regulatory requirements. 
• Partner with IT to collaborate and operationally support digital medical initiatives, including SharePoint governance, dashboard development, process optimization, and workflow automation. 
• In conjunction with Global Medical Training, manage logistics and operations for the All Medical Summit Meetings twice annually, ensuring seamless planning, cross functional coordination, and high quality execution. 
• Partner closely with Finance, Legal/Compliance, IT, Global Scientific Communications, and regional medical teams to ensure integrated, compliant, and efficient execution of medical operations. 
• Contribute as a hands on, collaborative member of the Global Medical Operations team, fostering a culture of teamwork, transparency, and operational excellence. 

Required Skills:

• Bachelor’s degree required. 
• 8-10 years in Medical Affairs or Medical Operations; emerging biotech experience strongly preferred. 
• Demonstrated hands-on experience executing medical operations activities. 
• Strong understanding of global medical compliance, HCP engagement standards, FMV principles, and congress operations. 
• Experience collaborating extensively with Legal/Compliance, Finance, IT, Global and Scientific Communications. 
• Proven ability to multitask, adapt quickly, and operate effectively in a fastmoving, environment. 
• Excellent communication, organizational, and project management skills. 
• A collaborative, solutions-oriented working style and the ability to build strong, positive relationships across teams. 

Preferred Skills:

• Emerging biotech experience strongly preferred. 

Additional Information: 

The base compensation range for this role is: $200,000 - $240,000. Compensation is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

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

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

Position Summary:

The Senior Director, Risk Management, Drug Safety & Pharmacovigilance (DSPV) will report to the Vice President, Drug Safety & Pharmacovigilance and will be responsible for our Risk Management strategy and Benefit Risk Office at Vera which strives for excellence and the creation of a best practice framework. As a Risk Management Lead, you will be empowered to work cross-functionally with colleagues to establish and manage the processes for Risk Management, benefit risk, RMPs, additional Risk Minimization Measures and REMS programs and other Benefit Risk deliverables. The overall goal of the Risk Management Lead is to optimize the proactive impact made by the PV department at Vera while maximizing patient safety and minimizing/preventing patient risk.

Responsibilities:

• Serves as Project manager of the PV Risk Management System to oversee, evaluate, characterize, strategize, implement, assess and track vera’s PV Risk Management obligations, commitments and proposed minimization measures to ensure patient safety is at the forefront of DSPV.
• Provide recommendations and guidance through subject matter expertise on risk management and risk minimization strategy to an assigned therapeutic area to ensure that product risk management strategies are consistent worldwide.
• Provide recommendations and guidance through subject matter expertise on the structured benefit risk assessment framework and the development of the benefit risk assessment documentation.
• Work closely with cross-functional teams (e.g. Clinical Development, Clinical Operations, Medical Affairs, Regulatory Affairs, and Biostats) to ensure alignment of Vera’s global position for the PV risk management processes.
• Provide strategic expertise to cross-functional product team members in developing pharmacovigilance risk strategies including benchmarking and scenario planning.
• Support the development of risk management plans (RMPs) in modular format, review RMPs) and ensure alignment with Good Pharmacovigilance Practices and other applicable regulations.
• Remain up to date and well informed on all Regulatory intelligence as it relates to risk management and relay this to the Project team and the PV medical safety science team.
• Aide in the development and review risk minimization documents such as Developmental RMPs, RMPs, risk minimization measures and Risk Evaluation and Mitigation Strategy (REMS).
• Provide subject matter expertise and thoughtful contributions to qualitative and quantitative structured benefit risk assessments.
• Provide guidance on incorporation of the patient’s perspective into benefit-risk activities (e.g. Real-World Evidence studies with Medical Affairs).
• Collaborate with PV Physician Leads, Clinical Leads, PV scientists and Clinical Research Scientists, and others cross-functional teams on benefit risk assessment strategy.
• Develop and provide recommendations for appropriate risk management interventions such as direct healthcare professional communications, educational materials, controlled access program.
• Provide guidance and drive the creation of tracking risk management commitments including utilization of a tracking spread sheet or platform and improvement assessments
• Monitor and report risk management metrics to ensure compliance.
• Provide centralized support, training, and leadership for safety and cross-functional members who work on risk management plans and risk minimization activities.
• Support inspections and audit activities internally and externally with regards to risk management processes.
• Perform other duties as defined in standard operation procedures or requested by supervisor.
• Work with PV Physician and PV Scientists to aide in the proper characterization and classification of Risk from initial signal to evaluation, validation, implementation in study documents, protocols, IBs, ICFs, and RMPs.
• Work with VP of DSPV, PV Physicians and PV Scientists on any Regulatory Submission/filing for BLA, SBLA, MAA, etc. to be sure that risks are reflected properly and carried through to support filing activities.
• Oversee risk components of Aggregate reports like DSUR, PBRER etc.
• Work with PV Physicians and PV Scientist in risk presentations at safety Governance meetings (MSRB & MSRC) to ensure proper communication of risk is achieved and proper course of action is followed.
• Manage and oversee any outsourced RMP related activities to external vendors.

Qualifications:

• PhD/Pharmacist/ PharmD/DO/MD with 12+ years of experience.
• Minimum 5-10 years in PV/safety OR clinical development preferred.
• Minimum 5-10 years of pharmaceutical industry/drug development experience.
• Pharmaceutical industry experience, with exposure to PV risk management, additional risk minimization measures, and/or REMS programs preferred.
• Strong track record of scientific and analytical thinking.
• Experience presenting at meetings is desirable.
• Work with integrity and work proactively in a fast-moving environment.
• Good Critical thinking skills. Ability to use good analytical/judgment skills to understand, analyze, and communicate.
• Project Management Skills with ability to manage both time and priority constraints and to manage multiple priorities simultaneously.
• Attention to detail, computer literacy, knowledge of safety databases.
• Good working knowledge of all the functions within PV from PV operations onto medical safety science and all processes in between.

The TMF Manager will report to the Executive Director, Clinical Quality Assurance and will support the quality and integrity of the Trial Master File (TMF) and electronic Trial Master File (eTMF) across clinical programs. This role helps ensure clinical trial documentation is complete, accurate, and maintained in accordance with regulatory requirements and industry standards throughout the clinical trial lifecycle.

The Clinical Quality Assurance organization partners with Clinical Development and cross-functional stakeholders to promote and maintain high-quality clinical research practices across the drug development lifecycle. The function provides independent oversight to ensure clinical trials are conducted in compliance with global regulatory requirements and that the organization maintains continuous inspection readiness.

This role provides oversight of Trial Master File management to ensure clinical trial documentation is organized, complete, and maintained in a state of continuous inspection readiness for our Vera studies. The individual partners with study teams, functional document owners, and system users to monitor TMF health, identify documentation gaps, and support effective TMF management throughout the lifecycle of clinical studies.

The position also serves as the eTMF system administrator and collaborates with Clinical Quality Assurance leadership to support system governance, implement improvements through appropriate change control processes, and provide training and guidance to study teams and functional stakeholders.

The role operates with a high degree of independence in monitoring TMF quality and completeness while working closely with cross-functional teams to ensure documentation practices align with regulatory expectations and organizational procedures.

Responsibilities:

• Provide oversight of Trial Master File management across clinical development programs and functions. The position partners closely with Clinical Operations, Clinical Supply Chain, Data Management, Pharmacovigilance, Regulatory Affairs, and other development functions to ensure essential clinical documentation is appropriately maintained within the TMF. Partner with study teams, functional document owners, and system users to facilitate periodic TMF health discussions and ensure alignment on TMF quality and completeness expectations.
• Interface with CROs and external vendors responsible for TMF activities and contributes to maintaining TMF inspection readiness across the organization. In addition, the position supports TMF lifecycle activities including study start-up planning, ongoing TMF maintenance, study closeout, and TMF archival in accordance with regulatory and company retention requirements.
• Contribute to establishing and maintaining consistent TMF management practices across studies and programs to support alignment with regulatory expectations and industry best practices.
• Conduct routine TMF health reviews and collaborate with study teams and document content owners to identify documentation gaps and ensure appropriate remediation.
• Oversee quality, completeness, and timeliness of Trial Master File (TMF/eTMF) documentation across clinical studies, ensuring appropriate governance of TMF practices across study teams and functional document owners.
• Develop and track eTMF metrics for studies and communicate trends or issues identified to study teams and management
• Serve as the eTMF system administrator, supporting user access management, system configuration support, troubleshooting, and ongoing optimization of system functionality to support TMF quality and inspection readiness.
• Support regulatory inspections and internal audits involving TMF records and management, including providing eTMF navigation and demonstration of TMF document structure and audit trail traceability.
• Collaborate with the Head of Clinical Quality Assurance and system users to identify opportunities to improve TMF processes, system functionality, and inspection readiness practices.
• Work with the eTMF system owner and IT or system support teams to implement system improvements in accordance with required change control and validation procedures.

 Qualifications:

• Bachelor’s degree plus 8 Years experience in life sciences, pharmacy, or related scientific discipline or commensurate work experience managing TMFs.
• Pharmaceutical, biotechnology, or CRO experience with direct involvement in Trial Master File management desired.
• Strong knowledge of regulatory requirements and industry expectations related to clinical trial documentation and Trial Master File management.
• Trial Master File (TMF) oversight and electronic TMF systems.
• Clinical trial documentation requirements and the TMF Reference Model.
• TMF health review and document completeness monitoring.
• Regulatory inspection readiness and inspection support.
• Cross-functional collaboration with clinical development functions.
• Working knowledge of global Good Clinical Practice (GCP) requirements and regulatory expectations for clinical trial documentation.
• Experience contributing to:
  • TMF process improvement initiatives
  • eTMF system administration or system governance
  • TMF metrics development and monitoring
  • TMF closeout and archival processes
• Experience working with CROs or vendors responsible for TMF activities.

Position Summary:

The Associate Director, Market Access Marketing will play a key role in supporting the launch of atacicept in a dynamic environment. This role will be responsible for executing market access marketing initiatives, including leading coverage assessments, advancing payer and market research, developing high-quality payer-facing materials, and supporting field team readiness. The Associate Director will work collaboratively with National and Regional Account Directors, Trade & Distribution, Patient Hub, Marketing, Commercial Operations, HEOR, Medical Affairs, and external partners to ensure access strategies are aligned, compliant, and effectively executed in support of launch objectives. The ideal candidate is a strategic, execution-oriented marketer who is highly organized, adaptable, and motivated to contribute to deliver strong launch execution and support the organization as it evolves beyond launch.

Responsibilities:

• Lead hands-on execution of market access marketing initiatives in support of the launch of atacicept.
• Translate access strategy into high-quality, payer-facing marketing materials, including payer value stories, access tools, and resources to support engagement with national and regional payers.
• Lead coverage assessments and competitive access analyses to inform payer trends, access strategies, and evolving market dynamics.
• Deliver training of field-based Market Access teams and ensure readiness with access materials.
• Partner cross-functionally with National & Regional Account Directors, Trade & Distribution, Patient Hub, Marketing, Commercial Operations, HEOR, and Medical Affairs to ensure alignment, consistency, and timely delivery of access-related initiatives.
• Drive launch readiness by managing access marketing deliverables, timelines, and review processes, ensuring materials are accurate, compliant, and available to support launch milestones.
• Manage agencies and external vendors, providing clear direction and oversight to ensure high-quality, on-time execution of access marketing initiatives.
• Operate effectively in a dynamic, pre-commercial environment, adapting priorities and approaches as launch plans and organizational needs evolve.
• Contribute insights from launch execution to inform future indication expansion and lifecycle access strategies, in partnership with cross-functional stakeholders.

Qualifications:

• Bachelor’s degree required; advanced degree (MBA, MPH, PharmD, or related field) strongly preferred.
• 7+ years of relevant experience in pharmaceutical/biotech market access, payer marketing, or related commercial function.
• 4+ years of experience in Market Access Marketing, Patient Support Services, and/or Payer Account Management
• Demonstrated success developing and executing payer-focused marketing tools, preferably in support of a product launch.
• Strong knowledge of the S. payer landscape, reimbursement pathways, and key access drivers across payer segment.
• Thorough understanding of Medical, Legal, and Regulatory (MLR) review processes and experience managing materials through approval.
• Highly organized and detail-oriented, with the ability to manage multiple access marketing workstreams, timelines, and stakeholders simultaneously.
• Proven project management, prioritization, and agility skills in fast-paced, evolving environments.
• Experience managing external vendors and agencies of record, with accountability for quality, timelines, and outcomes.
• Strong collaboration and communication skills, with the ability to influence across functions and levels in a matrixed organization.

Position Summary:

The Associate Director, Clinical Quality Assurance, will report to the Executive Director, Quality Assurance. The Associate Director, Clinical Quality Assurance serves as a key quality partner to clinical study teams and provides quality oversight of clinical development activities. This role contributes to strengthening a maturing Quality Management System (QMS) by identifying quality risks, supporting risk-based decision making, and ensuring quality practices are effectively implemented across clinical programs.

The Clinical Quality Assurance organization partners with Clinical Development and cross-functional stakeholders to promote and maintain high-quality clinical research practices across the drug development lifecycle. The function provides quality oversight to ensure clinical trials are conducted in compliance with global regulatory requirements and that the organization maintains continuous inspection readiness.

This role provides proactive Clinical Quality Assurance oversight for clinical studies and development functions. The individual partners closely with Clinical Operations, Pharmacovigilance, Data Management, Regulatory Affairs, and other development function and  serves as a key member of study teams, helping identify quality issues and risks,  and reviews quality events, investigations, and CAPAs; analyzing quality signals across studies and vendors that support risk-based decision making, and ensuring quality management practices are appropriately implemented throughout the clinical trial lifecycle.

The role operates with a high degree of independence in evaluating quality risks and compliance considerations while collaborating closely with cross-functional teams to support effective implementation of quality practices across clinical development programs.

The position contributes to strengthening the organization’s maturing Quality Management System (QMS) by supporting procedural governance, audit program oversight, and quality process improvement initiatives.

Responsibilities:

• Serve as the Clinical Quality Assurance representative on assigned clinical study teams, providing proactive guidance to ensure clinical trial conduct aligns with GCP and regulatory expectations.
• Provide oversight of clinical quality events, investigations, and CAPAs, ensuring appropriate root cause analysis, corrective actions, and identification of systemic quality trends.
• Analyze quality signals across studies, vendors, and operational processes to identify emerging risks and recommend mitigation strategies.
• Contribute to governance of the clinical audit program, including risk-based selection of audits and oversight of Audit CAPA follow-up. Execution of audits is performed by the audit function.
• Serve as a quality interface with CROs and vendor quality representatives to ensure appropriate management and resolution of quality issues.
• Support inspection readiness activities and provide first-line Clinical QA support during sponsor regulatory inspections, including preparation and follow-up actions.
• Review and provide input on new or revised SOPs and controlled documents to ensure alignment with regulatory requirements and consistency across organizational procedures.
• Provide input on training assignments and training matrices to ensure procedures are appropriately implemented across functional roles.
• Participate in process improvement initiatives that support the development and strengthening of the Quality Management System, including the evaluation, assessment, and implementation of quality governance, processes, and systems.

Qualifications:

• Bachelor’s degree in life sciences, pharmacy, or related scientific discipline required. Advanced degree preferred.
• Approximately 8+ years of industry experience, including leadership in clinical quality oversight or quality governance.
• Strong applied knowledge of global GxP regulations applicable to clinical development, including:
  • Good Clinical Practice (GCP)
  • Good Pharmacovigilance Practice (GVP)
  • Good Laboratory Practice (GLP)
  • GMP experience is not required for this role
• Experience with the following is desired:
  • Quality management and oversight of clinical trials
  • Quality event and CAPA management
  • Regulatory inspection readiness and inspection support
  • Risk-based quality management approaches
  • Planning of clinical audits (including sites, internal audits)
  • Developing metrics and reviewing issues for quality signals and trends
  • SOP governance through controlled document reviews
  • Training matrix or training governance activities
• Relevant certifications such as RQAP, CQA, CCRC, or RAC are considered a plus.

Job Title: Senior Scientific Communications Manager        

Location: Remote          

Role Overview: We’re looking for a Senior Scientific Communications Manager to join our growing biotech team. This is a hands-on role for someone who enjoys turning complex scientific and clinical information into clear, accurate, and useful communications for a variety of audiences.

At a small startup, this person will wear multiple hats. You’ll help shape our scientific story externally and internally, while also building and supporting core Medical Information capabilities. That means creating high-quality scientific materials and helping ensure that medical inquiries are addressed in a timely, accurate, balanced, and compliant way.

This role is a great fit for someone who is scientifically strong, highly organized, comfortable with ambiguity, and excited to build processes in a fast-moving environment.

Key Responsibilities: 

Scientific Communications

• Develop and refine clear, compelling scientific messaging across programs and stages of development
• Draft and manage scientific content such as:
• slide decks
• congress materials
• medical Information letters
• medical affairs and training materials
• FAQs and background documents
• external sci comm projects (e.g. webinars, podcast, product theaters, symposia)
• Translate preclinical, translational, and clinical data into audience-appropriate communications
• Partner cross-functionally with Medical Affairs, Clinical Development, Regulatory, and company leadership to ensure scientific accuracy and message consistency
• Help prepare materials for advisory boards, investigator meetings, and scientific congresses
• Contribute to the development of the company’s scientific narrative as programs advance

Medical Information

• Help build and maintain core Medical Information content and processes in an early-stage company environment
• Develop, review, and update standard medical response documents and reference materials
• Research and synthesize literature and internal data to support responses to unsolicited medical inquiries
• Ensure responses are accurate, balanced, evidence-based, and compliant with internal and external requirements
• Partner with Medical Affairs, Regulatory, and Pharmacovigilance to support appropriate documentation and escalation of medical inquiries, adverse events, and product complaints, as applicable
• Maintain a library of response letters, FAQs, and scientific references
• Identify trends in incoming medical questions and share insights with internal stakeholders
• Support training of internal teams on scientific messaging and Medical Information processes
• Help manage external Medical Information vendors or agency partners, when applicable

Other Requirements: the ability to travel at least twice yearly to company all hands meetings and optionally to scientific conferences where you feel your presence is of value

Qualifications: 

• Advanced degree in life sciences preferred
• Approximately 5+ years of relevant experience in scientific communications, medical communications, medical affairs, medical information, or a related biotech/pharma function
• Experience in dermatology or immunology strongly preferred
• Strong scientific writing and editing skills, with the ability to tailor content to different audiences
• Solid understanding of drug development, clinical research, and interpretation of scientific data
• Experience supporting scientific communications deliverables such as presentations and congress materials
• Experience developing or reviewing Medical Information content is strongly preferred
• Strong attention to detail and commitment to scientific accuracy and compliance
• Able to work independently, manage multiple priorities, and adapt quickly in a startup setting
• Experience working with vendors, medical writers, or outsourced contact center/Med Info partners
• Collaborative, practical, and comfortable working across functions with limited structure

Qualifications:

• Required BA/BS in related discipline, a combination of relevant education and applicable job experience may be considered
• Advanced degree in life sciences preferred
• Experience in the dermatology or immunology therapeutic areas highly preferred
• 5+ years of relevant experience in publications, medical affairs, scientific communications, or medical writing within biotech, pharma, or a medical communications environment
• Knowledge of ICMJE recommendations, Good Publication Practice guidelines, and standard publication planning processes
• Strong experience managing scientific publications, including manuscripts, abstracts, and posters
• Demonstrated experience working with and managing external medical writing vendors or publications agencies
• Strong understanding of publication planning, congress execution, and scientific data communication
• Excellent project management skills with the ability to manage multiple complex deliverables simultaneously
• Strong written and verbal communication skills, including the ability to provide thoughtful editorial and strategic feedback
• High attention to detail and commitment to scientific accuracy, quality, and compliance
• Ability to work cross-functionally and build strong relationships in a collaborative, fast-paced environment
• Ability to operate with autonomy and help build processes where structure is still evolving
• The ability to travel twice yearly to company all hands meetings and optionally to scientific conferences where presence is of value

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates, who will work remotely is $161,000 to $187,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.

Job Title: Senior Publications Manager         

Location: Remote          

Role Overview: We are looking for a Senior Publications Manager to lead publication planning and execution across our clinical and scientific programs. This role will be responsible for driving high-quality, timely development of manuscripts, abstracts, posters, and related scientific communications in close partnership with internal cross-functional teams and external medical writing vendors.

This is a highly collaborative, hands-on role for someone who understands the strategic importance of publications in biotech and can manage multiple deliverables across a fast-moving environment. The right person will be comfortable building processes, partnering with subject matter experts, and ensuring scientific outputs are accurate, compliant, and aligned with broader medical affairs and development objectives.

This role is ideal for someone who enjoys both strategy and execution and is excited to help build the publications function within a growing biotech company.

Key Responsibilities: 

Publications Strategy and Planning

• Lead development and execution of publication plans aligned with company strategy, clinical milestones, and medical affairs objectives
• Partner with Medical Affairs, Clinical Development, Biostatistics, Regulatory, and other internal stakeholders to identify publication opportunities and priorities
• Help define publication strategy across manuscripts, abstracts, posters, congress presentations, and other scientific outputs
• Maintain visibility into timelines, dependencies, and milestone-driven deliverables across programs
• Track relevant congress deadlines and publication opportunities to support proactive planning

Publication Development and Execution

• Manage end-to-end development of scientific publications, including:
• manuscripts
• review articles
• abstracts
• posters
• oral presentations
• encore materials, as appropriate
• Coordinate author review, internal review, and approval workflows to support on-time delivery
• Ensure materials accurately reflect scientific data and are consistent with agreed messaging and publication objectives
• Partner with internal subject matter experts to shape content direction, interpret data, and resolve comments efficiently
• Support preparation for scientific congresses by driving abstract and poster development from concept through final delivery
• Oversee publication timelines, status trackers, and document version control

Vendor and Agency Management

• Serve as the primary point of contact for external medical writing vendors and publications agencies
• Manage vendor scope, timelines, budgets, and deliverable quality
• Provide clear direction and feedback to vendors to ensure content meets scientific, stylistic, and strategic expectations
• Review drafts critically for scientific accuracy, clarity, completeness, and consistency
• Help establish productive, scalable ways of working with external writing partners
• Monitor vendor performance and help identify opportunities to improve efficiency, quality, and collaboration

Process and Compliance

• Help build and refine publications processes
• Ensure publication activities are conducted in accordance with internal policies, publication standards, and applicable industry guidelines
• Support documentation of publication decisions, authorship rationale, and review history as needed
• Contribute to publication governance, tracking, and planning tools that improve transparency and execution
• Promote high standards for scientific integrity, authorship practices, and publication quality

Qualifications:

• Required BA/BS in related discipline, a combination of relevant education and applicable job experience may be considered
• Advanced degree in life sciences preferred

• Experience in the dermatology or immunology therapeutic areas highly preferred.
• 5+ years of relevant experience in publications, medical affairs, scientific communications, or medical writing within biotech, pharma, or a medical communications environment
• Knowledge of ICMJE recommendations, Good Publication Practice guidelines, and standard publication planning processes.
• Strong experience managing scientific publications, including manuscripts, abstracts, and posters
• Demonstrated experience working with and managing external medical writing vendors or publications agencies
• Strong understanding of publication planning, congress execution, and scientific data communication
• Excellent project management skills with the ability to manage multiple complex deliverables simultaneously
• Strong written and verbal communication skills, including the ability to provide thoughtful editorial and strategic feedback
• High attention to detail and commitment to scientific accuracy, quality, and compliance
• Ability to work cross-functionally and build strong relationships in a collaborative, fast-paced environment
• Ability to operate with autonomy and help build processes where structure is still evolving
• The ability to travel twice yearly to company all hands meetings and optionally to scientific conferences where presence is of value

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates, who will work remotely is $161,000 to $187,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.

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

About Us

About the Role

The Director, Clinical Quality Assurance (QA), will be responsible for end-to-end quality oversight of global clinical trials to ensure compliance with applicable regulatory requirements and internal standards.

Reporting to the Sr. Director, Clinical QA, you will provide independent quality oversight of clinical development programs, ensuring that clinical trial conduct, data integrity, and sponsor oversight activities meet expectations of global regulatory authorities (e.g. ICH, FDA, EMA, MHRA, etc.)

You will partner cross-functionally with Clinical Operations, Clinical Development, Data Management, Pharmacovigilance, Bioanalytical, CMC, and Regulatory Affairs teams, while working closely with other functions of the Quality Unit (e.g. Clinical Quality Systems and Quality Systems and Compliance) to ensure the global GCPs are met for our clinical studies and to support inspection readiness and quality system alignment. Your role will be integral in assuring Dianthus is always inspection ready. You must possess experience and skill collaborating and influencing CRO’s, laboratories, and other clinical vendors in order to be successful in this role.

This is a unique opportunity to join a rapidly growing organization and have a significant impact at Dianthus. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.

Key Responsibilities

• Provide proactive, risk-based quality oversight for global clinical trials across all phases (e.g. Phase I, II, and III).
• Serve as the primary QA lead for clinical development programs, ensuring quality is embedded from study design through close-out.
• Ensure compliance with ICH E6 (R3) GCP and applicable global regulations (e.g. FDA, EMA, MHRA, etc.)
• Provide expert guidance on quality risk management, issue escalation, and mitigation strategies.
• Establish and maintain robust sponsor oversight frameworks for CROs and other third-party vendors.
• Ensure effective oversight of delegated activities, including monitoring, data management, and safety management.
• Collaborate with the Quality Unit to assess vendor qualification, performance metrics, and compliance trends.
• Lead and execute a risk-based GCP audit program, including investigator site audits, clinical vendor/CRO audits, and clinical process/system audits.
• Align audit strategy with clinical milestones and BLA readiness.
• Oversee audit findings, CAPAs, and effectiveness checks, ensuring timely and sustainable resolution.
• Ensure data integrity principles (ALCOA++) are embedded across clinical programs.
• Partner with the Director/Sr. Director of Clinical Quality Systems and the Sr. Director of Quality Systems and Compliance to support inspection readiness activities, provide audit insights and risk signals, contribute to inspection strategy and preparation.
• Participate in regulatory inspections as a QA subject matter expert.
• Act as a trusted advisor to Clinical Development and Operations leadership.
• Drive a culture of quality, compliance, and continuous improvement.
• Provide QA input and conduct QC of protocols, amendments, CSRs, and regulatory submission components.
• Provide quality oversight of bioanalytical activities, including review of bioanalytical method validation documentation to ensure alignment with regulatory expectations and clinical program needs.
• Lead or contribute to quality governance forums and risk review boards.
• Identify and assess systemic quality risks and compliance gaps
• Ensure appropriate classification and management of protocol deviations, serious breaches, and inspection findings.
• Escalate critical risks to senior leadership with clear, risk-based recommendations.
• Additional duties may be identified by functional management based on current project/business objectives.
• Some travel (approx. 20%) is required for company meetings and support of audits or regulatory inspections (e.g. in support of Sr. Director Quality Compliance as needed).

Experience

• BS or MS degree in life sciences or related field required.
• 12+ years of experience in GxP with minimum of 5+ years in GCP within the biotech or pharmaceutical industry.
• Deep knowledge of GCP regulations and guidance’s (e.g. ICH, FDA, EMA, MHRA, etc.)
• Significant experience supporting global clinical trials (e.g. Phase I, II and III).
• Demonstrated experience supporting or leading submissions and regulatory inspections (e.g. BLA, PMA, BIMO).
• Deep expertise of Sponsor oversight and CRO/vendor management responsibilities.
• Deep expertise in data integrity principles and risk-based quality management.
• Demonstrated experience in clinical audit strategies including investigator site audits, audit execution, and CAPA management.
• Experience working with or managing eQMS platforms and quality processes.
• Knowledge of Clinical Quality Systems.
• Experience with project management processes / tools to support in meetings, assist with project planning, and facilitate completion of tasks.
• Proven ability to lead strategically while remaining hands-on in a fast-paced biotech environment and risk-based thinking is critical.
• Proven capability to drive alignment and influence stakeholders across global, cross-functional organizations.
• Ability to translate regulatory expectations into practice, risk-based solutions.
• Excellent communication skills with the ability to engage senior leadership and regulatory inspectors.

Are you a politics expert or government professional eager to shape the future of AI? Large-scale language models are evolving from simple conversational tools into systems capable of analyzing policy, interpreting legislation, and supporting civic education. With high-quality training data, tomorrow’s AI can help democratize access to political knowledge, strengthen public understanding of governance, and support informed decision-making. That training data begins with you—we need your expertise to help power the next generation of AI.

We’re looking for political science specialists and professionals with real-world experience in local, state, national, or international government. This includes backgrounds in public policy, legislative affairs, public administration, political campaigns, regulatory analysis, international relations, and civic institutions. You’ll challenge advanced language models on topics such as constitutional frameworks, policy trade-offs, electoral systems, legislative procedure, political theory, comparative government, public budgeting, ethics in governance, and the practical realities of policymaking—documenting failure modes so we can strengthen model reasoning and neutrality.

On a typical day, you will engage the model with policy scenarios, governance questions, and political analysis tasks; verify factual accuracy and institutional correctness; assess logical consistency and bias risks; capture reproducible error traces; and provide structured feedback to improve prompts, evaluation standards, and analytical depth. You may also help identify where models oversimplify political processes or misinterpret procedural rules.

A degree in political science, public policy, public administration, international relations, or a related field is preferred. Experience working in government offices, legislative bodies, advocacy organizations, regulatory agencies, campaigns, or civic institutions is highly valued. Clear, metacognitive communication—explicitly articulating reasoning and decision processes (“showing your work”)—is essential, particularly when analyzing complex or sensitive topics.

Ready to turn your political expertise into the knowledge foundation for tomorrow’s AI? Apply today and help train systems that support civic understanding and responsible public discourse.

We offer a pay range of $6 to $65 per hour, with the exact rate determined after evaluating your experience, expertise, and geographic location. Final offer amounts may vary from the pay range listed above. As a contractor you’ll supply a secure computer and high-speed internet; company-sponsored benefits such as health insurance and PTO do not apply.

Job title: Politics & Government Specialist – Freelance AI Trainer Project
Employment type: Freelance / Contract
Workplace type: Remote
Seniority level: Entry Level