Associate Director, Clinical Operations

🔥 2 minutes ago

🇺🇸 United States – Remote

💵 $180k - $205k / year

⏰ Full Time

🟠 Senior

🏥 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 • Help set and execute 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, pharmacovigilance, and other activities • Maintain relationships with clinical study site personnel to ensure protocol adherence, Good Clinical Practice, quality data, and study timelines • Oversee study conduct at centers, including site selection, start-up, monitoring, protocol/GCP adherence, guidance compliance, and study closure • Contribute to clinical study protocols and protocol amendments • Assist with Investigator Brochures, FDA Briefing Documents, and presentations • Review Investigator Sponsored Trials and supporting documentation • Contribute to internal SOPs and Clinical work practice documents aligned with FDA and EMA regulations • Interface with the Chief Medical Officer/Medical Monitor and cross-functional teams • 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 duties as assigned

🎯 Requirements

• Bachelor’s Degree in health or science-related area • 8+ years of pharmaceutical, biotech-related, or clinical research experience • Oncology/immuno-oncology experience required • Experience leading Phase 1–4 trials and supporting investigator-initiated trials • Success managing clinical studies within timeline and budget • Managerial, interpersonal, verbal, and written communication skills • Ability to build relationships across functional teams • Ability to assimilate information quickly and implement needed changes • Negotiating, influencing, and problem-solving skills • Ability to maintain accountability and quality in deliverables • Proactive, self-directed, adaptable approach • Flexibility to perform necessary tasks in a fast-paced biotechnology environment • 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 such as eClinical, Medidata RAVE, and InForm • Exposure to Safety/Pharmacovigilance databases such as ARGUS • Available to travel up to 20% of the time • Ability to meet the stated physical, visual, communication, and mental demands of the role

🏖️ Benefits

• Remote office environment • Equal-opportunity and inclusive work environment • Reasonable accommodations available upon request