The posting
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics, Inc. is the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors. Amtagvi® (lifileucel) is the first FDA-approved, one-time treatment for previously treated advanced melanoma, now approved in three global markets and available at more than 95 authorized treatment centers. The Iovance TIL platform spans registrational trials and next-generation programs in additional solid tumors, including gene-edited and IL-12 tethered TIL therapies, next-generation IL-2, and precision immuno-oncology approaches. As the first and only company to take TIL therapy from concept to a broadly accessible commercial treatment, Iovance operates as an end-to-end cell therapy company, anchored by fully owned, centralized U.S.-based manufacturing that is scaled to serve thousands of cancer patients worldwide each year. For more information, please visit www.iovance.com.
Amtagvi® and its accompanying design marks, Proleukin®, Iovance®, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners.
Information on Iovance’s broad, industry-leading patent portfolio is available on the Intellectual Property page on www.iovance.com.
Overview
The Associate Director, R&D and Commercial IT partners with R&D and Commercial stakeholders to select, implement, and support the systems that run Iovance's clinical development, regulatory, safety, and commercial operations. This is an individual contributor role in collaboration with managed services partners. This role is responsible for leading the transition of regulatory information management from Veeva Vault RIM to Generis CARA. Additionally, it serves as system owner and administrator for a portfolio of validated R&D applications and a set of Commercial applications. The role carries a primary R&D focus, and the ideal candidate has R&D domain expertise and is open to learning and administering the Commercial systems.
Essential Functions and Responsibilities
- Lead the Veeva Vault RIM to Generis CARA transition, including scope, timeline, data migration, validation, cutover, vendor and stakeholder coordination, and status reporting to leadership.
- Partner with Clinical Data Management, Clinical Operations, Regulatory Affairs, Drug Safety, and Biometrics to understand business needs, translate them into system requirements, and deliver IT solutions.
- Serve as system administrator and business/IT owner for R&D applications, including Generis CARA / Veeva RIM, Veeva eTMF, Argus Drug Safety, DocuBridge, and Magnifi LMS (Clinical).
- Serve as system administrator for Commercial applications, including Veeva CRM (event management and ENGAGE), Veeva Network, Veeva PromoMats, and Magnifi LMS (ATC Ops), and partner with Commercial stakeholders on enhancements and new requirements.
- Manage user access, security roles, configuration, releases, upgrades, and vendor-driven change in line with change control procedures.
- Ensure systems are validated and maintained in compliance with FDA 21 CFR Part 11, GxP, and applicable data integrity requirements, and support audits and inspections as needed.
- Author, review, and maintain system documentation, such as validation deliverables, SOPs, work instructions, and configuration specifications.
- Direct the work of a vendor resource that supplements the internal team, including assigning priorities, reviewing deliverables, and monitoring performance against the statement of work.
- Manage vendor and managed-service relationships, including SLAs and statements of work.
- Provide escalation support for incidents and problems, and drive root-cause analysis and corrective actions.
- Contribute to budgets and roadmaps for the R&D and Commercial application portfolio.
- 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 Information Systems, Computer Science, Life Sciences, or a related field, or equivalent experience.
- 10+ years of IT experience in biotech, pharmaceutical, or life sciences, including 5+ years supporting R&D or clinical/regulatory systems.
- Hands-on experience administering and configuring one or more of: Veeva Vault (RIM, eTMF, or other), Argus Safety, or comparable regulated R&D applications.
- Working knowledge of GxP, 21 CFR Part 11, and computer system validation.
- Experience leading system implementations or migrations through the full lifecycle.
- Experience managing vendors and consultants.
- Strong understanding of at least two R&D functions: Clinical Operations, Clinical Data Management, Regulatory Affairs, Drug Safety/Pharmacovigilance, or Biometrics.
- Strong communication, stakeholder management, and project management skills.
- Willingness to learn and administer Commercial systems.
Preferred Education, Skills, and Knowledge
- Direct experience with regulatory information management (RIM) implementations or migrations, ideally Generis CARA.
- Experience with Veeva CRM, Network, or PromoMats, or with an LMS such as Magnifi.
- Experience in cell or gene therapy, oncology, or other advanced-therapy environments.
- PMP, Veeva Vault administrator, or similar certifications.
- Familiarity with regulatory submission publishing and eTMF inspection readiness.
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
- Ability to engage in analytical, conceptual, and problem-solving activities in a dynamic business environment
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 with a sense of urgency; 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
The annual base salary we reasonably expect to pay is listed. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of the role, job duties/requirements, and relevant education, experience and skills.
Pay Transparency
$175,000—$200,000 USD
The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.
Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact [email protected].
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