Director of Trade, Distribution and Patient Assistance

Job description

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.With our purified, high-precision cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. **Summary of Role:** the Director of Trade, Distribution and Patient Assistancewill own the strategy, buildout, and day-to-day operation of the distribution channel through which Orca Bio’s portfolio moves from Orca to the point of care. Reporting to the Head of Market Access, you will be accountable for our third-party logistics (3PL) partner, our specialty pharmacy network, and the end-to-end distribution and order-to-cash pathway that supports Authorized Treatment Center (ATC) ordering, government-channel ordering, and patient assistance program and fulfillment. You will serve as the primary point of contact for our 3PL, specialty pharmacy partners, and patient assistance hub while translating distribution requirements into operational reality, and partner closely with Finance, Legal, Compliance, Technical Operations, and the field team to ensure every dose is ordered, shipped, delivered, and reconciled without disruption to patient care. ### Responsibilities **Third-Party Logistics (3PL) & Distribution Operations** - Develop and execute a comprehensive trade, channel and patient assistance strategy for Orca Bio product(s), including the design and oversight of TREGZI’s distribution network. - Serve as the primary point of contact for the 3PL relationship, owning the operational relationship and issue resolution. - Finalize and maintain the 3PL Business Requirements Document (BRD) and ensure distribution processes reflect the approved requirements. - Own the end-to-end distribution model design, including title flow, order intake, delivery, returns/replacement handling for out-of-spec or failed product, and reconciliation. - Establish and maintain state licensing. - Develop, maintain and oversee standard operating procedures (SOPs) and governance processes, including returns, credits, charge backs and other trade related policies. - Collaborate with finance to ensure timely data reporting and payments to and from customers, review and approve key transactional data/reports including orders, credits, reinvoicing, or chargebacks, as appropriate. - Manage Credit and Cancellation Policies and processes. - Monitor 3PL performances and compliance to business requirement documents. **Specialty Pharmacy Network** - Own the specialty pharmacy (SP) channel strategy and lead activation of operational SP pathways as a distribution option for ATCs. - Manage the SP relationships through contracting and implementation, including recurring implementation calls and resolution of open legal/finance redlines. - In collaboration with Product Supply, Finance and Market Access finalize end-to-end SP process flows and ordering. - Lead contract negotiations and oversee compliance with SP agreements. - Monitor SP partners performance to ensure compliance to service level agreements and key performance indicators. - Identify opportunities for continuous improvement to ensure timely access to product. - Evaluate data to identify trends and support business strategies. **Patient Assistance & Free-Drug Fulfillment (Channel Operations)** - Develop and maintain policies for patient assistance programs and ensure they are compliant with OIG guidance. - Partner with the PAP program hub on the operational pull-through of travel and lodging program, along with other patient assistance programs keeping distribution mechanics compliant with policy. **Cross-Functional Partnership & Compliance** - Partner with Finance to ensure distribution flows support accurate government price reporting, gross-to-net, and revenue recognition tied to the appropriate point in the channel. - Partner with Legal and Compliance to ensure all trade agreements and channel practices comply with Orca's policies and applicable laws and regulations. - Coordinate with Technical Operations / Supply Chain to align ordering, manufacturing slot allocation, cold-chain logistics, and delivery so the commercial channel and vein-to-vein supply chain operate as one. - Support ATC agreement execution where distribution, ordering, credit, and cancellation terms are implicated, in coordination with the Market Access and Legal teams. - Provide trade and distribution input into pricing changes, including coordination of any downstream channel. ### Qualifications - Bachelor's degree required; advanced degree (MBA or related) preferred. - Minimum of 10 years' experience in pharmaceutical/biotech trade, channel, distribution, or specialty operations, with at least 5 years in a trade/distribution leadership role. - Direct experience managing 3PL and/or specialty pharmacy relationships and contracts is required. - Cell and gene therapy, transplant, or other cold-chain / limited-distribution product experience strongly preferred, including familiarity with chain-of-identity and chain-of-custody requirements. - Strong background of U.S. distribution economics, government channels (340B, VA), government price reporting, and gross-to-net mechanics. - Experience supporting a product launch strongly preferred. - Demonstrated ability to build and operate a distribution model from the ground up and to manage external partners to operational milestones. - Strong cross-functional collaborator able to partner effectively with Finance, Legal, Compliance, Technical Operations, and field teams. - Strong contract negotiation skills and cross functional leadership. - Experience in the U.S. healthcare marketplace is required. - Travel is required as part of this position (up to 30%). - Ability to maintain confidentiality and to operate with the highest ethical standards and professionalism.