Director, New Product Launch

Job Summary

The Director, New Product Launch (NPL) leads the planning and execution of global launches for 3rd-party sourced pharmaceutical products, including in-licensed, co-developed, and acquired assets. These products span across generics, specialty, and brands & biosimilar categories.

This role oversees the NPL team responsible for guiding products post-regulatory submission through commercial launch, ensuring high-quality, on-time, and correct-volume launches at the SKU level in all markets. Working closely with external partners, internal stakeholders, and executive leadership, the Director ensures alignment of launch strategies, risk mitigation, and flawless execution.

Job Responsibilities

• Strategic Leadership & Executional Performance
  • Develop and execute NPL strategies for 3rd-party sourced products that align with corporate growth objectives.
  • Oversee the creation of launch readiness plans that meet commercial, operational, and customer service requirements from submission through post-launch review.
  • Ensure early identification of risks and activation of mitigation plans, particularly with external partners and co-development sites.
  • Champion the Stage-Gate process to maintain disciplined, timely decision-making.Data-
• Team Leadership and Development
  • Lead, mentor, and develop the project management team focused on externally sourced products, fostering a high-performance, collaborative culture.
  • Ensure each team member has clear job descriptions, objectives, and development plans.
  • Oversee recruitment, onboarding, training, and ongoing performance management in compliance with corporate policies and applicable regulatory requirements.
• Operational Excellence
  • Drive launch execution efficiency by coordinating with internal functions (R&D, Regulatory, Quality, Operations, Marketing, Sales) and external partners.
  • Monitor and optimize resource allocation across multiple, complex launches with aggressive timelines.
  • Establish annual departmental goals, budgets, KPIs, and reporting mechanisms specific to 3rd-party sourced portfolios.
• Partner & Stakeholder Management
  • Build and maintain strong working relationships with licensing partners, co-development collaborators, and third-party manufacturers.
  • Serve as the primary escalation point for all launch-related issues within the 3rd-party sourced portfolio.
  • Ensure transparent communication and alignment across stakeholders and geographies.
• Continuous Improvement & Innovation
  • Identify and implement best practices, process enhancements, and technology solutions to improve launch speed, predictability, and quality.
  • Stay informed on industry trends, regulatory changes, and partner capabilities, incorporating them into NPL processes.
• Governance & Compliance
  • Ensure all launches meet GMP, regulatory, and quality requirements, as well as internal governance policies.
  • Maintain thorough documentation for audits, inspections, and internal reviews.
• Other Duties
  • Uphold corporate values and culture in all activities.
  • Perform other duties as assigned.

Job Requirements

Education & Experience

• Bachelor’s degree in Science, Engineering, Business, or related field (MBA or advanced degree preferred).
• Minimum 10 years of progressive experience in pharmaceutical operations, supply chain, or product launch, with at least 5 years in a leadership role.
• Direct experience managing launches for externally sourced products, including in-licensed, co-developed, and acquired assets.
• Strong understanding of GMP, regulatory submissions (ANDA, NDA, 505(b)(2)), and multi-market launch requirements.

Skills & Competencies

• Proven leadership and team development skills in a matrixed, global environment.
• Strategic thinking combined with hands-on project management expertise.
• Strong relationship-building skills with external partners and internal stakeholders.
• Excellent problem-solving, decision-making, and communication abilities.
• Proficiency with project management systems and data analytics tools.