National Access Director - West
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Your missionWe are looking for creative, highly motivated individuals to help prepare for the successful launch of an innovative allogeneic T-cell immunotherapy in the US, Tabelecleucel (Tab-Cel) which is an investigational cell therapy for the treatment of Epstein Barr positive post-transplant lymphoproliferative disease.
The U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) resubmission for tabelecleucel (tab-cel® / Ebvallo), setting a target action date of March 31, 2027, under the Prescription Drug User Fee Act (PDUFA).
The National Access Director will play a critical role in preparing for launch and facilitating urgent access to Tab-cel once approved. In the pre-approval phase, they will work closely with Pierre Fabre’s Cell Therapy Account Directors and Field Medical Directors to support site operational onboarding and readiness leading up to and after the anticipated approval of the Tab-Cel. They will be responsible for pre- and post-approval information exchanges with payers to ensure payers have the appropriate data and information required to enable coverage decisions and provide a pathway to coverage for patients who may be prescribed the Tab-cel post approval. Critically, they will ensure that financial stakeholders at treating facilities and payers have timely access to information needed to navigate the preparation for the relevant prior authorization process and potential single case agreements.
This is an exciting opportunity to be part of an organization that is preparing to launch a new class of advanced therapeutics while making a meaningful impact on the lives of patients with a life-threatening disease. Pierre Fabre Pharmaceuticals offers unique development opportunities, and we are looking for candidates that have a growth mindset and thrive in a start-up environment that will be scaling up the Pierre Fabre presence in the US pharmaceuticals market. We value individuals who exhibit behaviors such as team collaboration, humility, innovative thinking, and patient centric approach to the business.
ESSENTIAL FUNCTIONS:
- Operate in compliance with all laws, regulations and policies that govern the conduct of Pierre Fabre activities
- Facilitate urgent access to Tab-cel post approval by educating payer customer segment and treatment center financial stakeholders of value proposition of product
- Contributes to the US Value and Access Team by monitoring trends, policy changes, and implications and taking ownership of this expertise
- Seek opportunities for synergy and partnership to achieve both Pierre Fabre and customer goals through active and transparent planning and customer engagement with cross functional Team
Tab-Cel Support
- Enable payer coverage assessment for Tab-Cel through pre-approval information exchange and post-approval with national and regional payers in the Commercial, Medicare, and VA sectors
- Support overall access strategy with engagement of Federal Payers and Medicare FFS
- Educate payers on the urgent unmet need and provide resources to ensure a pathway to coverage in the pre and post approval regulatory setting
- Identify appropriate payer stakeholders for the therapy and partner with payer colleagues to establish path for expedited review of cases
- Provide approved product education and health economic information to key customers in payer and provider segment to communicate the value proposition of the product.
- Ensure financial and reimbursement confidence and communicate payer coverage with providers post approval
- Partner with treatment sites and key stakeholders to educate on reimbursement process, coverage and coding details relevant for the Therapy post approval, ensuring stakeholder comfort and confidence in their reimbursement process
- Liaise with external specialty distributor counterpart(s) to meet objectives while providing a best-in-class experience for sites of care
- Proactively communicate payer co...
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