Senior Clinical Trial Manager, Research Alliances

🕒 April 22

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Iovance Biotherapeutics, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2014

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

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

• 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.

🎯 Requirements

• 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).