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 Senior Manager oversees GMP manufacturing operations and contract manufacturing for protein production, focusing on downstream processes like formulation and lyophilization. They collaborate with cross-functional teams to manage technical transfers, process improvements, and regulatory CMC activities.
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 Lead Endpoint Engineering Architect will design and implement the company's endpoint management platform using Microsoft Intune, Autopilot, and Entra ID. This role involves hands-on engineering, including application packaging, PowerShell scripting, and automating business processes via Power Automate and SharePoint.
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.
The Director of Scientific Marketing will lead the strategic direction for medical education and peer-to-peer activities supporting AMTAGVI for metastatic melanoma. This role involves developing educational content, managing speaker programs, and collaborating with cross-functional teams to drive brand strategy.
Develop, validate, and maintain statistical programming deliverables including SDTM, ADaM datasets, and TLFs for clinical studies and regulatory submissions. Collaborate with cross-functional teams to ensure GxP-compliant delivery of analysis specifications and reporting needs.
The Senior Manager of Biostatistics provides statistical leadership for complex cell therapy oncology clinical studies, overseeing study design and the interpretation of results. This role involves collaborating with cross-functional teams and managing CROs to ensure high-quality statistical deliverables and regulatory compliance.
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 Associate Counsel will review, negotiate, and manage various third-party contracts and develop legal templates. They will also provide legal training to employees and advise internal clients on contract management policies.
Lead the development and infrastructure of the US Field Medical Affairs organization, including hiring and managing a high-performing MSL team. Represent the field team internally and externally to support product launches and pipeline development.
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.
