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Job Description:

The Associate Director, Medical Affairs CAR-T is responsible for medical and scientific leadership for Johnson & Johnson’s CAR-T strategy. This role is responsible and accountable for providing high level, evidenced-based, scientific expertise to internal and external partners.

The successful candidate will lead the Integrated Evidence Generation Process (IEGP) in collaboration with the therapeutic area team and in direct communication with the global organization. He/She/They will provide scientific support for evidence generation activities including local Phase IV clinical studies and Investigator Initiated Studies. He/She/They will also work closely with external sites to ensure seamless integration of CAR-T into the health care system.

Responsibilities include but are not limited to:

• Collaborate with the Therapeutic Area Head to develop and deploy the launch strategy for CAR-T in alignment with internal stakeholders and external CAR-T treating physicians, coordinators and sites
• Drive pre-launch and launch activities and strategic projects from Launch Readiness (LRT), Medical integration (MIT) and Patient Value Teams (PVT).
• Co-lead the design and execution of CAR-T strategy at PVT level.
• People management: lead the CAR-T field medical operation role
• Collaborate closely with internal stakeholders to align on portfolio strategy in relevant therapeutic areas or disease states.
• Work with Therapeutic Area Head to secure required resources to execute the Medical Affairs Plan and manage the resources appropriately
• Identifies data gaps for each product within the respective disorders areas and develops a Data Generation Plan Presents data gaps to Global team and actively participates in the research approval process, ReCAP
• Participates and represents Canada on the global Med Affairs Team (GMAT)
• Liaise with multiple global partners to provide expertise and to ensure Canadian needs are met in collaboration with the Therapeutic Area Head, lead and partner in interactions with key individual stakeholders to provide input and decision-making into short, medium, and long-range solutions to ensure appropriate data generation and data communication strategies
• Champion Investigator Initiated & collaborative Studies to meet Canadian needs & oversight of final deliverables
• Accountable for CAR-T medical budget execution.
• Accountable to own publication strategy, planning and execution
• Develop and maintain relationships with external investigators and opinion leaders involved in the delivery of CAR-T or engaged in CAR-T studies
• Liaise with CAR-T treating physicians and centers to obtain and review relevant patient specific medical information
• Identify the opportunity to gather relevant information via Scientific Advisory Boards, including development of an agenda, identifying attendees, overseeing the conduct of Ad Boards
• Work with internal stakeholders and external CAR-T treating physicians, coordinators and sites to provide medical analysis and support to manage out of specification commercial CAR T products
  

Qualifications:

Educational Requirements:

• MD, Ph.D or Pharm D required.

Requirements:

• Board certification in Medical Oncology, Hematology or relevant work experience in Medical Oncology or Hematology is desired.
• Experience in CAR-T, hematopoietic stem cell transplantation, or other cellular therapy is preferred.
• A minimum of 5 years of combined relevant experience in a medical/clinical environment and/or scientific function in the pharmaceutical industry is required.
• A minimum of 2 years of Supervisory or People Management experience is preferred.
• Strong written and verbal communication skills are required
• This position requires up to 25% annual travel (domestic and international travel).

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.