Director of Trade, Distribution, Patient Assistance
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Job Description
Directing trade, distribution, specialty pharmacy, and patient assistance operations for Orca Bio’s next-generation cell therapies. Managing partners, compliance, cold-chain logistics, and end-to-end product access.
Responsibilities:
- Develop and execute a comprehensive trade, channel and patient assistance strategy for Orca Bio products, 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 and ensure distribution processes reflect approved requirements.
- Own end-to-end distribution model design, including title flow, order intake, delivery, returns/replacement handling, and reconciliation.
- Establish and maintain state licensing.
- Develop, maintain, and oversee SOPs and governance processes, including returns, credits, chargebacks, and trade-related policies.
- Collaborate with Finance on data reporting, customer payments, orders, credits, reinvoicing, and chargebacks.
- Manage credit and cancellation policies and processes.
- Monitor 3PL performance and compliance.
- Own specialty pharmacy channel strategy and lead activation of operational specialty pharmacy pathways.
- Manage specialty pharmacy relationships through contracting and implementation.
- Finalize end-to-end specialty pharmacy process flows and ordering with Product Supply, Finance, and Market Access.
- Lead contract negotiations and oversee compliance with specialty pharmacy agreements.
- Monitor specialty pharmacy performance against service-level agreements and KPIs.
- Identify continuous-improvement opportunities and evaluate data to identify trends.
- Develop and maintain compliant patient assistance program policies.
- Partner with the patient assistance program hub on travel, lodging, and other patient assistance program operations.
- Partner with Finance on government price reporting, gross-to-net, and revenue recognition.
- Partner with Legal and Compliance on trade agreements, channel practices, policies, laws, and regulations.
- Coordinate with Technical Operations and Supply Chain on ordering, manufacturing slot allocation, cold-chain logistics, and delivery.
- Support Authorized Treatment Center agreement execution involving distribution, ordering, credit, and cancellation terms.
- Provide trade and distribution input into pricing changes and downstream channel coordination.
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.
Benefits:
- Pre-IPO equity
- Annual bonus
- Competitive medical benefits
- Dental benefits
- Vision benefits
- PTO
- 401(k) plan
- Life and accidental death and disability coverage
- Parental leave benefits
- Subsidized daily lunches and snacks at on-site locations
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