Associate Director, R&D, Commercial IT

🔥 14 hours ago

🇺🇸 United States – Remote

💵 $175k - $200k / year

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 0%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Iovance Biotherapeutics, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2014

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Iovance Biotherapeutics, Inc. is pioneering a transformational approach to treating cancer by harnessing the human immune system's ability to recognize and attack diverse cancer cells in each patient. The company focuses on T-cell-based immunotherapy, specifically Tumor Infiltrating Lymphocyte (TIL) therapy, which involves reinvigorating a patient’s TILs to fight cancer. Iovance's TIL therapy is being investigated in clinical trials across multiple advanced solid tumor cancers. Additionally, the company is advancing genetically modified TIL therapies and exploring potential applications of PBL (peripheral blood lymphocyte) therapy for blood cancers. As a leader in cell therapy, Iovance owns a state-of-the-art Cell Therapy Center in Philadelphia for manufacturing their therapies using proprietary GMP. The company is at the forefront of developing personalized and patient-specific cancer treatments.

📋 Description

• Partner with R&D and Commercial stakeholders to select, implement, and support systems for clinical development, regulatory, safety, and commercial operations • Lead the transition from Veeva Vault RIM to Generis CARA, including scope, timeline, data migration, validation, cutover, vendor and stakeholder coordination, and leadership status reporting • Translate business needs into system requirements and deliver IT solutions with Clinical Data Management, Clinical Operations, Regulatory Affairs, Drug Safety, and Biometrics • Administer and own R&D applications including Generis CARA/Veeva RIM, Veeva eTMF, Argus Drug Safety, DocuBridge, and Magnifi LMS (Clinical) • Administer Commercial applications including Veeva CRM, Veeva Network, Veeva PromoMats, and Magnifi LMS (ATC Ops) • Manage user access, security roles, configuration, releases, upgrades, and vendor-driven changes under change-control procedures • Ensure validation and compliance with FDA 21 CFR Part 11, GxP, and applicable data-integrity requirements; support audits and inspections • Author, review, and maintain validation deliverables, SOPs, work instructions, and configuration specifications • Direct vendor resources, assign priorities, review deliverables, and monitor statement-of-work performance • Manage vendor and managed-service relationships, including SLAs and statements of work • Provide escalation support, drive root-cause analysis, and implement corrective actions • Contribute to budgets and roadmaps for the R&D and Commercial application portfolio • Adhere to Iovance Biotherapeutics’ values, policies, procedures, and business ethics • Perform miscellaneous duties as assigned

🎯 Requirements

• 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: Direct experience with regulatory information management (RIM) implementations or migrations, ideally Generis CARA • Preferred: Experience with Veeva CRM, Network, or PromoMats, or with an LMS such as Magnifi • Preferred: Experience in cell or gene therapy, oncology, or other advanced-therapy environments • Preferred: PMP, Veeva Vault administrator, or similar certifications • Preferred: Familiarity with regulatory submission publishing and eTMF inspection readiness • 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 • Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion • Ability to handle work-related stress and multiple priorities simultaneously with a sense of urgency • Ability to meet deadlines

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume