Senior Clinical Trial Manager, Research Alliances

Overview

The Senior Clinical Trial Manager (CTM) in the Research Alliances team will independently lead and is accountable for the planning, execution, management, and reporting of clinical projects supporting Iovance commercial activities, including Expanded Access Programs (intermediate EAP, single-patient and Ex-US Access Programs) and Phase 4 post marketing studies. In addition, the Sr. CTM/CTM will provide operational leadership for studies within a growing portfolio of Investigator Sponsored collaborations and other non-clinical collaborative research initiatives involving lifileucel and Proleukin. This position works very closely with external vendors, HCPs, as well as multiple Iovance teams: Commercial, Medical Affairs, Regulatory, Safety, Clinical, Biometrics, Quality, Legal, Quality, Supply Chain & Logistics and Manufacturing.

The ideal candidate will have clinical operations experience within the pharma/biotech arena, be self-motivated, and able demonstrate the ability to manage complex programs independently while collaborating effectively in a dynamic, agile, and evolving organization.

Essential Functions and Responsibilities

• 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 required.