Director, New Product Launch
Amneal · Bridgewater
Description:
The Director, New Product Launch is responsible for the end-to-end commercial leadership of injectable generic and complex generic product launches, beginning at product selection and continuing through the first year following commercial launch. This individual serves as the commercial quarterback for each launch, leading cross functional planning and execution across Commercial, R&D, Operations, Regulatory Affairs, Medical Affairs, Supply Chain, Finance, Market Access, Quality, Legal, Compliance, and Customer Operations.The role combines strategic launch excellence, market intelligence, hospital pharmacy expertise, product awareness strategies, and operational execution. Success requires deep knowledge of the institutional injectable marketplace, including hospital purchasing, GPOs, IDNs, buy and bill reimbursement, coding, product shortages, and competitive dynamics.The Director will establish launch strategy, monitor launch performance, anticipate market disruptions, and drive cross functional decisions that maximize product adoption, supply continuity, and financial performance.
Essential Functions:
- Portfolio and Launch Leadership: Develop launch strategies for institutional injectable products; lead all assigned injectable generic and complex generic product launches from concept through twelve months after commercial launch; chair cross functional launch governance meetings and drive accountability across functions. recommend launch timing based on market conditions, competitive landscape, and manufacturing readiness; establish commercial success metrics and monitor launch performance.
- Institutional Commercialization: Develop and maintain integrated launch, communication, and commercialization plans and score cards with clearly defined milestones, owners, risks, and mitigation strategies.
- Market Intelligence: Monitor competitive launches, FDA approvals, shortages, backorders, recalls, pricing changes, and manufacturing disruptions; analyze market share trends and customer purchasing behavior; Develop competitive intelligence reports for executive leadership; identify commercial opportunities created by competitor supply disruptions.
- Supply Continuity and Shortage Management: Coordinate commercial responses during shortages; Support commercial activities related to recalls; coordinate customer communications during recalls; monitor customer impact and recovery efforts
- Compliance and Promotional Review: Ensure all launch activities comply with company policies and applicable regulations; lead projects through Promotional Review Committee approval; partner with Legal, Regulatory, and Compliance throughout launch execution; maintain adherence to FDA promotional requirements; coordinate launch materials with Medical, Legal, and Regulatory review committees
- Billing, Coding and Reimbursement: Serve as the commercial lead for reimbursement readiness; collaborate with reimbursement experts and external partners, including BuyandBill.com; coordinate HCPCS coding strategy and reimbursement communications; monitor reimbursement trends affecting product adoption; support customer education related to coding and reimbursement