The analyst will manage the Computer Systems Validation (CSV) lifecycle, including creating documentation, executing implementation tasks, and ensuring regulatory compliance. They will also coordinate validation projects, manage change controls, and perform periodic reviews of computerized systems and data integrity.
Develop, validate, and maintain statistical programming deliverables including SDTM and ADaM datasets to support clinical studies and regulatory submissions. Collaborate with cross-functional teams to ensure high-quality reporting and compliance with GxP standards and regulatory guidelines.
The Cell Therapy Account Manager will drive demand for Amtagvi by building referral networks between community practices and academic centers. They will serve as the primary commercial point of contact to onboard new service lines and ensure operational excellence in cell therapy delivery.
The Associate Director will oversee the management and execution of non-personal promotion content for HCP and patient audiences across digital channels. They will partner with cross-functional teams to develop integrated engagement strategies, manage media agencies, and optimize campaign performance through data-driven insights.
The Cell Therapy Account Manager will drive demand for Amtagvi by building referral networks between community practices and academic centers. They will also serve as the primary commercial point of contact to onboard new TIL service lines and ensure operational excellence at authorized treatment centers.
The Associate Director serves as a field-based medical leader responsible for advancing medical strategy through high-impact scientific exchange and cross-functional collaboration. They manage relationships with key opinion leaders and clinical investigators while providing scientific support for developmental and marketed products.
The Cell Therapy Account Manager will drive demand for Amtagvi by building referral networks between community practices and academic centers. They will serve as the primary commercial point of contact, onboarding new service lines and collaborating with internal teams to ensure operational excellence.
The Compensation Analyst will support the administration and development of compensation structures, policies, and programs while providing strategic analytical support. This role involves partnering with HRBPs and leadership to ensure pay equity, market competitiveness, and compliance with regulatory requirements.
The Associate Director leads global regulatory strategy and submissions for drug development programs, ensuring alignment with health authority expectations. They collaborate with cross-functional teams to execute clinical-regulatory development plans and manage interactions with global regulatory bodies.
The Senior Manager, Supply Planning designs and implements clinical supply strategies, including forecasting, budgeting, and distribution oversight at external CMOs. They also manage label development, IRT system testing, and collaborate with cross-functional teams to ensure uninterrupted supply for clinical trials.
The Director of Clinical Operations leads the clinical operations team and manages the execution of clinical research programs from conception to final study report. They oversee budgets, vendor contracts, and cross-functional collaboration to ensure adherence to protocols and regulatory standards.
The CSP Oversight Specialist II is responsible for the qualification, reassessment, and risk-based oversight of clinical service providers to ensure GCP compliance. They manage quality events, negotiate quality agreements, and represent the CQA function in study management team meetings.
The Cell Therapy Account Manager will drive demand for Amtagvi by building referral networks between community practices and academic centers. They will serve as the primary commercial point of contact, educating site personnel and collaborating with internal teams to ensure operational excellence.
The Associate Director owns the production, publication, and accuracy of Iovance’s external digital presence across multiple platforms. They will leverage AI-assisted tools to streamline content creation while ensuring compliance with regulatory standards and maintaining brand consistency.
The role involves designing, building, and deploying production-grade AI systems, specifically focusing on RAG applications and LLM integrations. The engineer will own the end-to-end architecture, security, and evaluation of AI agents within a regulated life sciences environment.
Drive high-impact communications across investors, media, and employees by translating company strategy and clinical data into compelling materials. Manage investor relations logistics, media relations, and cross-functional alignment to support corporate visibility and investor engagement.
Manages the planning, compilation, and submission of INDs, BLAs, and CTA amendments. Represents Regulatory Affairs on cross-functional teams to ensure high-quality documentation and adherence to corporate objectives.
The Lifecycle Leader is responsible for shaping the program vision and strategic lifecycle plan across global indications. They lead cross-functional teams to ensure timely delivery of milestones and provide strategic recommendations to the Executive Leadership Team.
Coordinate and manage the planning, compilation, and submission of CMC dossier content for clinical and commercial applications. Ensure adherence to eCTD specifications and manage regulatory correspondence with health authorities like the FDA.
