Director, Clinical Operations

Job not on LinkedIn

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $225k - $240k / year

⏰ Full Time

🔴 Lead

🏥 Clinical Operations

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Iovance Biotherapeutics, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2014

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

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

• Lead and manage the assigned clinical operations team and contribute to departmental strategy • Oversee clinical trial agreements, budgets, expenditures, and payments • Ensure timely execution of clinical research programs and protocols from conception through final clinical study report • Supervise external contract organizations responsible for site interaction, monitoring, data management, biostatistics, IRB interaction, central laboratory functions, budget negotiation, medical writing, and pharmacovigilance • Establish relationships with clinical study site personnel and ensure protocol, Good Clinical Practice, data-quality, and timeline adherence • Oversee study conduct at centers, including site selection, start-up, monitoring, protocol/GCP adherence, applicable guidance, and study closure • Contribute to clinical study protocols and protocol amendments • Assist with Investigator Brochures, FDA Briefing Documents, and internal or external presentations • Review Investigator Sponsored Trials and supporting documentation • Contribute to Iovance SOPs and Clinical work practice documents and implement plans aligned with FDA and EMA regulations • Interface with the Chief Medical Officer/Medical Monitor and cross-functional teams including Data Management, Drug Safety, Logistics/Manufacturing, Project Management, Regulatory Affairs, and Biostatistics • Directly supervise Clinical Operations team members, including performance management and development planning • Represent the company at external meetings and scientific congresses • Adhere to company values, policies, procedures, and business ethics • Perform miscellaneous assigned duties

🎯 Requirements

• Bachelor’s Degree in health, or science related area • 12 to 16 years of pharmaceutical or biotech-related/clinical research experience, with oncology/immuno-oncology experience required • Demonstrated experience leading phase 1–4 and supporting Investigator-initiated trials • Demonstrated success managing clinical studies within timeline and budget • Demonstrated managerial skills and strong verbal and written communication skills • Ability to build strong relationships across functional teams • Ability to assimilate information quickly and implement immediate change when needed • Negotiating, influencing, and problem-solving skills • Ability to maintain accountability and quality in deliverables • Proactive, self-directed, adaptable, and able to thrive in a rapidly changing environment • Flexible and dynamic approach in a fast-paced biotechnology company • In-depth knowledge of PC operating systems and Microsoft Office, including Word, Excel, PowerPoint, Project, Publisher, Outlook, and Windows NT • Exposure to CTM systems, EDC systems (eClinical, Medidata RAVE, InForm), and Safety/Pharmacovigilance databases (ARGUS) • Available to travel up to 20% of the time • Must meet stated physical and mental demands, including prolonged sitting or standing, computer use, repetitive wrist/hand/finger motions, communication, judgment, troubleshooting, analysis, discretion, multitasking, and meeting deadlines

🏖️ Benefits

• Equal-opportunity employment • Reasonable accommodations available upon request • Remote office environment