Iovance Biotherapeutics
Biopharmaceutical
ClinicalTrialManager
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“Clinical Trial Manager at Iovance Biotherapeutics. Skills: Clinical trial management, Biopharmaceutical operations, Regulatory submissions. Support operational execution of clinical studies. Manage implementation of clinical studies”
What You'll Achieve.
Lead to registrational submissions of BLAs; Ensure program/study objectives are successfully accomplished; Deliver data and statistical analyses
Industry & Context.
Troubleshooting; Problem-solving; Analysis; Creative approach to challenges
Must be able to move about inside an office, Requires operating standard office equipment
What They're Looking For.
Must Have
Bachelor's degree, 5+ years pharmaceutical/biotech/clinical research experience, 1+ year as CTM, Demonstrated experience in core/technical aspects of designing, initiating, managing phase 1-4 clinical trials, Demonstrated experience in management of CROs, Demonstrated experience in vendor selection, Subject matter expert in US and Global Regulations and Guidance (SOPs, ICH-GCP, FDA-CFR, ethical standards), Broad scope experience in data collection, monitoring, cleaning, and analysis throughout clinical development (Phase 1-4), Ability to remain stationary for prolonged periods, Ability to exert up to 10 pounds of force occasionally, Visual acuity to perform activities such as preparing and analyzing data and figures, viewing a computer screen, and extensive reading, Repetitive motion, substantial movements of the wrist, hands, and/or fingers, Ability to communicate with others to exchange information, Clear and conceptual thinking, Excellent judgment, Troubleshooting, Problem-solving, Analysis, Ability to handle multiple priorities, Ability to meet deadlines
Nice to Have
Experience in oncology or research
What You'll Do.
Support operational execution of clinical studies
Manage implementation of clinical studies
Manage on-time execution of clinical studies
Manage conduct of clinical studies
Oversee cross-functional study team members
Ensure initiation of clinical program
Ensure execution of clinical program
Manage program/study objectives
Lead vendor identification
Lead vendor qualification
Lead vendor selection
Manage systems management
Support trial endgame delivery
Critically assess data
Critically review vendor groups
Supervise vendor groups
Ensure data integrity
Perform routine data reviews
Perform consistency checks
Track program progress
Communicate program progress
Communicate study progress
Assess impact of regulations
Assess impact of guidance
Make modifications to projects
Approach challenges creatively
Optimize conduct of clinical trials
Adhere to core values
Adhere to business ethics
Perform miscellaneous duties
How You'll Work.
Team & Collaboration
Cross-functional clinical team
Communication Scope
Communication skills
Process & Methodology
Clinical program management, Clinical study management
Full Job Description
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer. Overview The Clinical Trial Manager has operations experience within the biotech/biopharma arena. This individual has a high level of core competencies and technical skills to be applied within the management of clinical programs leading to registrational submissions of Biologic License Applications (BLAs). The Clinical Trial Manager position is an opportunity for an individual to join a cross-functional clinical team having high-visible and dynamic input in a therapeutic indication of unmet medical need and orphan disease status. Essential Functions and Responsibilities Support the overall operational execution of clinical studies on one or more clinical programs from initial study synopsis through final project deliverables (ie, database hard-lock, final TLFs, CSR, etc.) Manage the implementation, on-time execution and conduct of clinical studies; including the development of budget items, milestones and timelines, in addition to scope and management of resources (including vendor selection). All leading to overall quality, safety, and compliance throughout the duration of the clinical studies and program. Oversight of cross-functional study team members to ensure initiation and execution of the clinical program within approved budget and timelines Risk management and mitigation including prioritization of competing tasks and issues to ensure program/study objectives are successfully
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