Director, New Product Launch
Amneal
Summary
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.
Job description
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.
Qualifications
Education: MBA or Master's degree in Business, Marketing, Healthcare Administration, or related field – Preferred. Doctor of Pharmacy from an ACPE accredited College of Pharmacy – Preferred.
Experience: 7 years or more in Commercial, marketing, business operations, market access, product management, launch excellence, or portfolio management experience. 5 years or more in direct involvement in product launches, preferably injectable, biosimilar, specialty, hospital, or complex generic products. 2 years or more in Pharmaceutical manufacturing. 2 years or more in Clinical experience in an acute care hospital setting or an accredited residency or fellowship.
Specialized Knowledge: Strategic thinking, Launch excellence, Commercial acumen, Hospital pharmacy expertise, Financial analysis, Demand forecasting, Market intelligence, Cross functional leadership, Executive communication, Project management, Customer focus, Decision making under ambiguity, Influence without authority, Operational excellence.
Requirements
- 7 years or more in Commercial, marketing, business operations, market access, product management, launch excellence, or portfolio management experience
- 5 years or more in Direct involvement in product launches, preferably injectable, biosimilar, specialty, hospital, or complex generic products
- 2 years or more in Pharmaceutical manufacturing
- 2 years or more in Clinical experience in an acute care hospital setting or an accredited residency or fellowship
- MBA or Master's degree in Business, Marketing, Healthcare Administration, or related field – Preferred
- Doctor of Pharmacy from an ACPE accredited College of Pharmacy – Preferred
- Strategic thinking
- Launch excellence
- Commercial acumen
- Hospital pharmacy expertise
- Financial analysis
- Demand forecasting
- Market intelligence
- Cross functional leadership
- Executive communication
- Project management
- Customer focus
- Decision making under ambiguity
- Influence without authority
- Operational excellence
Benefits
- Health insurance
- Insurance benefits
- 401(k) matching contribution
- Short-term incentive opportunity
- Performance-based award
Company overview
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) is a leading American publicly traded pharmaceutical company headquartered in Bridgewater, New Jersey. Founded in 2002 by brothers Chirag and Chintu Patel, the company has grown to become one of the largest and fastest-growing generic pharmaceutical manufacturers in the United States. Amneal operates as an integrated pharmaceutical company focused on developing, manufacturing, and distributing generic, brand, and biosimilar products. With approximately 8,100 employees globally, the company maintains operations across North America, Asia, and Europe. Amneal's business is organized into three main segments: a robust U.S. generics business with over 250 product families, a growing specialty pharmaceuticals division focused on central nervous system disorders and endocrine conditions, and an expanding biosimilars portfolio. The company has established itself as a leader in complex dosage forms and difficult-to-manufacture products, with manufacturing capabilities spanning oral solids, injectables, ophthalmics, liquids, topicals, transdermals, and respiratory devices. Amneal's mission 'We make healthy possible' reflects its commitment to providing affordable access to essential medicines while maintaining high-quality standards across its global operations.