Iovance Biotherapeutics
Biotech
AssociateMedicalDirector
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“Associate Medical Director at Iovance Biotherapeutics. Skills: Clinical trial support, Program development, Drug development. Provide physician-supported clinical trial support. Oversee direction of clinical trials”
Industry & Context.
Troubleshooting; Problem-solving; Analysis
10-15% travel, Stationary position for prolonged periods, Move about inside office, Exert up to 10 pounds of force, Repetitive motion, Substantial movements of wrist, hands, fingers, Communicate with others
What They're Looking For.
Must Have
MD (Hematology/Oncology highly desired), 1-2 years oncology clinical trials experience, Effective oral and written communication skills, Excellent interpersonal skills, Demonstrated independence, Demonstrated initiative, Ability to work well in fast-paced environment
Nice to Have
Subspecialty training in oncology, Subspecialty training in hematopoietic transplantation, Outstanding academic achievement, Significant clinical trial experience
What You'll Do.
Provide physician-supported clinical trial support
Oversee direction of clinical trials
Oversee planning of clinical trials
Oversee execution of clinical trials
Oversee interpretation of clinical trials
Serve as primary point of clinical contact
Direct protocol implementation
Identify clinical trial sites
Communicate with Clinical Operations
Attend investigators' meetings
Correspond with sites regarding patient eligibility
Correspond with sites regarding safety considerations
Interact with US Medical Affairs teams
Interact with Global Medical Affairs teams
Co-manage program development
Report to Executive Medical Director
Collaborate cross-functionally for drug development
Collaborate cross-functionally for therapy development
Monitor clinical trials
Oversee trial conduct
Contact investigators
Contact site study staff
Contact CRO medical monitors
Support data analysis
Support data assembly
Support IDMC meetings
Support interim analyses
Support clinical study report writing
Contribute to abstract preparation
Contribute to presentation preparation
Contribute to manuscript preparation
Perform miscellaneous duties
How You'll Work.
Team & Collaboration
Cross-functional collaboration; Study Management Team
Communication Scope
Oral communication; Written communication
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 Associate Medical Director is primarily responsible for physician-supported clinical trial support and overseeing the direction, planning, execution, and interpretation of IOVANCE clinical trials. Essential Functions and Responsibilities Primary point of clinical contact for IOVANCE clinical trials. Directs protocol implementation including site identification and communication with Clinical Operations, attendance at investigators’ meetings (virtual and live), correspondence with sites regarding patient eligibility and safety considerations, and interaction with US- and Global Medical Affairs teams Co-manages program development and reports directly to Executive Medical Director. Responsible for cross-functional collaboration with all of the disciplines necessary for successful drug/therapy development (Study Management Team level): clinical, manufacturing, quality assurance, regulatory, medical affairs, legal, biostatistics, global patient safety, data management, pharmacovigilance, and clinical operations Monitors clinical trials including the oversight of all aspects of trial conduct and safety, contact with investigators and site study staff, and CRO medical monitors Supports data analysis and assembly, including IDMC meetings, interim analyses, IB authoring, and clinical study report writing Contributes to the preparation of abstracts, presentations, and manuscripts in
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