Director, Oncology Pre-Approval Access

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 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 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. Program Execution & Oversight.

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.

Stakeholder Engagement & Communication

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.

Compliance & Risk Management

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.

Program Close-Out

Support of PADU execution of global program and country-specific exit strategies in alignment with SOP timelines.

Qualifications:

Bachelors degree in life sciences pharmacy nursing or related field required. Advanced degree preferred.

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.

Location & Travel:

This position is based in Raritan NJ.

Approximately 1015% travel both domestic and international may be required.

The anticipated base pay range for this position is $160000 - $276.000.

The Company maintains highly competitive performance-based compensation programs. Under current guidelines this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporations performance over a calendar/performance year. Bonuses are awarded at the Companys discretion on an individual basis.

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical dental vision life insurance short- and long-term disability business accident insurance and group legal insurance.

• Employees may be eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).

• This position is eligible to participate in the Companys long-term incentive program.

• Employees are eligible for the following time off benefits:

  • 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 of Work Personal and Family Time - up to 40 hours per calendar year

• Additional information can be found via the following link: compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. 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 & 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 contact us via or contact AskGS to be directed to your accommodation resource.

  Required Skills:

  Preferred Skills:

  Analytical Reasoning Business Requirements Analysis Clinical Research and Regulations Clinical Trials Operations Communication Developing Others Digital Culture Digital Literacy Healthcare Trends Inclusive Leadership Leadership Medical Affairs Medical Communications Medical Compliance Product Strategies Stakeholder Analysis Strategic Thinking Workflow Analysis

  The anticipated base pay range for this position is :

  $164000.00 - $282900.00

  Additional Description for Pay Transparency: