orcabiosystems - Orca Bio - Director of Trade, Distribution and Patient Assistance

Remote - USA+ Equity4w ago

Remote Director NA Payments Pharmaceuticals Sales Director Director of Customer Success Regulatory Affairs Specialist MBA Reporting Documentation Product Marketing Contract Negotiation

Requirements

• 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. • The anticipated annual salary range (listed above) for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.

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.