Director, Oncology Pre-Approval Access

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Job Function:

Medical Affairs Group

Job Sub Function:

Medical Affairs

Job Category:

People Leader

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

Johnson & Johnson Innovative Medicine is recruiting for a Global Medical Affairs Leader for Lung. The preferred location for this position is Raritan, NJ.

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine

The Director, Oncology Pre-Approval Access (PAA) Project Owner is a representative from the Compound Development Team for Medical Affairs and part of the PAA Program team with an overall accountability for obtaining funding and program approval, to developing treatment guidelines, country exit plans and to connect strategy and operational functions together. The PAA Project Owner will closely collaborate with the Trial Delivery Leader (TDL) throughout the planning and execution of the program. This role supports cross-functional efforts to help ensure PAA programs are established per established internal and external requirements.

This individual will collaborate closely with cross-functional stakeholders including Patient Strategies & Solutions (PSS) , Post Approval Delivery Unit (PADU), R&D, Oncology Global Medical Affairs, Regulatory Affairs, Clinical Supply Chain, Pharmacovigilance, and Legal. The PAA Project Owner will partner closely with the Compound Development Team Leader (CDTL), Global Medical Affairs Leader (GMAL), Patient Strategies & Solutions (PSS) Liaison, and Post Approval Delivery Unit (PADU) teams to ensure timely and compliant delivery of Oncology PAA programs.

Key Responsibilities:

The Oncology PAA Program Owner is the first point of contact within Oncology Global Medical Affairs and is the primary point of contact for the GMAL, CDTL, MRP and the interface with PADU and PSS.

Early Identification

·       Collaborate and coordinate with PSS on the early identification of IMPs that are likely to receive PAA requests.

·        Ensure funding is secured at Investment Committee and a high-level budget placeholder is requested for clinical supplies/program costs.

Program Strategy & Planning

·       Collaborate with CDTL and GMAL to support the development and execution of the PAA Strategic Plan and facilitate required stakeholder feedback and input for endorsed programs.

·       Coordinate creation of documentation required for internal and external committee reviews.

·       Collaborate with CDTL and GMAL for early asset planning and clinical development plans to inform PAA strategy.  Participate in meetings with CDTL, GMAL, MRP and PAA Liaison (PSS) to define the most appropriate PAA pathway.

·       Initiate regional discussions to align country expectations with business planning. Ensure PAA timelines are consistent with the GFLS.

·       During the development of the Strategic Plan, coordinate with Clinical Supply Integration (CSI) and Program Delivery Lead (PDL) to ensure supply readiness and feasibility assessments

·       Coordinate and facilitate review and alignment with CDT to ensure approp