Kelly Services is currently seeking a Medical Director with CAR-T experience for a long-term engagement with one of our Global Pharmaceutical clients.
This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.
Work with internal stakeholders and external CAR-T treating physicians, coordinators and sites to provide medical analysis in support in preparation for launch
Provide medical monitoring and medical oversight for company sponsored MA led interventional and observational clinical trials
Support the development of compliant promotional materials and the training of product representatives
Maintain relationships with external investigators and opinion leaders through Advisory Boards and international meetings
Support the development of scholarly publications arising from Janssen Biotech studies. Support the development of product monographs and responses to product inquiries
Lead internal review meetings and formulate risk/benefits reports. He/ she will handle risk/benefits communications with CAR-T administering physicians and centers
Lead and partner in interactions with key individual stakeholders (i.e., CMC, manufacturing, regulatory, quality assurance, safety management and clinical) to provide input and decision-making into short, medium, and long-range solutions to ensure appropriate data generation and data communication strategies. Lead and effectively partner with Alliance partner on those activities.
Liaise with CAR-T treating physicians and centers to obtain and review relevant patient specific medical information.
MD is required.
Board certification in Medical Oncology, Hematology or relevant work experience in Medical Oncology or Hematology is preferred but not required
Experience in CAR-T, hematopoietic stem cell transplantation, or other cellular therapy is required.
A minimum of three years of Medical Affairs and/or Clinical Research & Development experience in the pharmaceutical industry, or one year of industry experience combined with three or more years of relevant clinical research experience in academic medicine, is required.
A minimum of 2 years of Supervisory or People Management experience is preferred.
Experience with malignant hematology as well as CAR-T development and Medical Affairs approaches is preferred.
Experience in clinical trial design and conduct (Phases II, III or IV), including interventional oncology clinical trials, is preferred.
This position requires up to 25% annual travel (primarily domestic with some international travel).
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