Senior Director, WW Medical Cell Therapy, Operations & Product Sciences

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The Head of Cell Therapy Operations & Product Sciences, WW Cell Therapy Medical  will be an office based position overseeing the Cell Therapy operations & product sciences team. The individual will represent WW CT Medical as therapeutic area expert in Cell Therapy and provide clinical/scientific leadership for all aspects related to non-conforming products and their release through the material review boards as well as other aspects of product sciences related questions.  He/she will provide input into process improvement activities to allow for scaling of BMS cell therapy offering. He/she will support approved CAR T products as well as Cell Therapy compounds in various stages of clinical development. He/she will be accountable for the oversight of the nonconformed CAR T expanded access protocols including overseeing the respective clinical trial physician as indicated. He/she will be accountable for the clinical research scientist(s) overseeing the EAP studies. He/she will support the affiliate CAR T Medical teams by providing training on site onboarding activities including training in collaboration with the asset and disease leads. 

This individual’s responsibilities will include strategic and tactical planning of Medical Cell Therapy program site support and provide oversight for those Medical colleagues who are the point of contact for site launch experience. He/she will need to have the capability to travel and provide on-site support for designated CAR T sites as needed in collaboration with the medical field team. He/she will represent WW CT Medical as needed, serving as a therapeutic area expert in Cell Therapy products.

Responsibilities will include, but are not limited to, the following:

• Ensure positive first CAR T clinical experience for each product by providing in depth training to Medical staff involved in site on boarding and site support.

• Point of contact for clinical issues related to nonconforming products including participation in internal material review board and primary medical person responsible to communicate information to treating physicians related to nonconforming products.

• Supervision of team members that are the point of contact for escalated calls from HCPs treating patients with BMS CAR T products that come thru the call center or medical unsolicited requests.

• Assist the field medical team (MSL), office-based Medical and cross-functional partners during CAR T program site qualification, certification process and release of non-conforming products.

• Assist and lead post-launch CART site support and strategy in collaboration with the local medical team.

• Collaborate in the development of training materials for sites and medical field team and provide training for both external and internal stakeholders including REMS and RMP.

• Lead and support various Medical cross-functional working groups with priority to activities related to CAR T product sciences, site qualification, verification and post-launch CAR T site support.

• Responsible for refining strategies and identify best practices for optimal medical scientific support for Cell Therapy programs.

• Develop tools to assist sites in ease and quality of care to patients..

• Collaborate with Asset leads to define, guide and execute CAR T strategies and tactics with appropriate use of resources.

• Support CAR T medical affairs studies (e.g. registries, protocols).

• Provide therapy area medical and scientific expertise to clinical study teams and key stakeholders.

• Represent the WW CT Medical as a therapeutic expert at ad boards and steering committee.