Director, Oncology Pre-Approval Access

Johnson & Johnson • Raritan, NJ

4d • Onsite

About The Position

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.

Requirements

• Bachelor’s degree in life sciences, pharmacy, nursing, or related field required.
• Minimum of 6 years of experience in clinical operations, medical affairs, or regulatory affairs within the pharma industry.
• Experience must include pre-approval access experience.
• Strong understanding of global regulatory frameworks and related to pre-approval access.
• Proven ability to manage complex cross-functional projects and drive operational excellence.
• Excellent communication, organizational, and problem-solving skills.

Nice To Haves

• Advanced degree preferred.

Responsibilities

• 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.
• 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 appropriate awareness and funding allocation for PAA programs.
• Lead discussions and facilitate reviews to develop and finalize Treatment Guidelines in alignment with governing SOP and Work Instruction.
• Manage strategy documentation and updates for Treatment Guidelines in collaboration with GMAL, CDTL and MRP.
• Monitor program, conduct/attend regular meetings as a representative and delegate of Global MAF to ensure alignment and execution of the PAA Strategic Plan and R&D approved budget.
• Review documentation that requires GMAL or CDTL signature to ensure consistency across programs.
• Coordinate with PADU and Local Representatives to ensure country-specific requirements are met for program activation and patient enrollment.
• Serve as an escalation point as a representative for Oncology Global MAF, notifying appropriate stakeholders as required (e.g. PSS, PADU).
• Support communication of program status, updates, and closure plans as needed.
• Ensure adherence to global SOPs and regulatory requirements in all PAA activities for which Global Medical Affairs is responsible and accountable.
• For vetted PAA Strategies with publication plans, support pub planning and review processes for int/ext dissemination of PAA program information, in compliance with company SOPs.
• Support of PADU execution of global program and country-specific exit strategies in alignment with SOP timelines.

Benefits

• medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• Company’s long-term incentive program.
• Vacation – up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
• Holiday pay, including Floating Holidays – up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Director