Lupin is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions. Together these entities make up the generic and branded U.S. business. Lupin has a significant generic pipeline, and a branded focus on women’s health. Our first Research and Development facility in the US is located in Coral Springs, Florida which focuses on generic and branded orally inhaled and nasal drug products. Somerset, New Jersey is home to one of twelve commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin, as well as additional Research and Development teams. Lupin is prided on being people-focused and centered around how impactful we are with our customers. Dollars are not a measure of success but rather the people we help along the way.

The Director of 505(b)(2) Portfolio Management, will lead Lupin's innovative portfolio with strategic vision and an expertise in innovation. The role encompasses driving the ideation process, overseeing internal evaluations, and collaborating on a comprehensive portfolio strategy. Utilizing seasoned leadership, this role will craft Product Profile Charters, lead cross-functional assessment process and steer the 505(b)(2) Product Review Committee process. Engaging with market research initiatives and external partnerships, this leader will navigate regulatory landscapes, ensuring informed decision-making.

Essential Duties & Responsibilities

• Accountability for proactively identifying, assessing opportunities that could enhance Lupin’s portfolio, in line with Lupin’s growth strategy.
• Lead and manage the ideation process to generate innovative ideas for the 505(b)(2) portfolio.
• Coordinate and facilitate the activities of the Innovation Council to harness creative thinking and cross-functional collaboration.
• Coordinate internal evaluations of concepts, involving medical, marketing, and other relevant stakeholders to assess preliminary market potential and prioritize the concepts for detailed evaluation
• Ensure comprehensive assessments of concept viability and alignment with business goals.
• Collaborate with third party organizations to design and execute market research initiatives.
• Manage relationships with external partners to gather valuable insights and data for portfolio decision making.
• Prepare and process marketing surveys to gather data on market trends, customer preferences, and competitive landscapes.
• Analyze market research findings to inform strategic decisions and portfolio positioning.
• Lead the initial commercial assessment and collaborate with the sales and marketing team to create scenario based forecasts for 505(b)(2) products based on market research and internal assessments.
• Work closely with finance and commercial teams to refine and validate forecast models.
• Prepare Product Profile Charters outlining key attributes, target patient populations, and competitive differentiation for 505(b)(2) products.
• Manage the 505(b)(2) Product Review Committee (PRC) process.
• Facilitate stage gate approvals for the progression of products through the development and commercialization pipeline.
• Collaborate closely with business development, strategy and the other functions to assess new growth opportunities
• Assume accountability for organizational results.
• Influence others to achieve and or exceed objectives and lead the decision-making process for critical programs and initiatives. Routinely makes decisions that affect current and long-range corporate objectives.
• Effectively structure sales forecasts, P&L’s, and to understand sensitivity and risk analyses and company valuations; deep knowledge of discounted cash flow, net present value (NPV), internal rates of return (IRR) and other risk analysis techniques.
• Efficiently and effectively lead a multitude of simultaneous projects with a high degree of independence.
• Consistently deliver on commitments in a timely manner.

• A minimum of 10/12 years of experience in Pharmaceutical industry with at least 5 years in Business Development role.
• A minimum of a Master's degree in Business, Pharmaceutical Sciences, or a related field. An advanced degree (MBA, PharmD) is highly preferred.
• Proven executive-level experience in pharmaceutical portfolio management, with a focus on 505(b)(2) products.
• Demonstrated ability to lead cross-functional teams and drive results in a dynamic and fast-paced environment. Strong strategic thinking and visionary leadership to guide the 505(b)(2) portfolio toward innovative and successful outcomes.
• Exceptional analytical and problem-solving skills, with the ability to interpret complex data, market trends, and internal evaluations. Proficiency in utilizing data to drive strategic decision-making and portfolio optimization.
• Excellent interpersonal and communication skills, with the ability to effectively collaborate with internal stakeholders, external partners, and regulatory bodies. Adept at presenting complex information in a clear and concise manner.
• Strong project management skills, including the ability to manage multiple initiatives simultaneously, prioritize effectively, and meet deadlines. Experience in leading and facilitating the stage gate approval process.
• Familiarity with market research methodologies and tools. Experience in coordinating and leveraging third-party organizations to gather valuable insights for portfolio decision-making.
• Proven ability to develop accurate and insightful commercial forecasts for pharmaceutical products. Collaboration with finance and commercial teams to refine and validate forecast models.
• A passion for driving innovation within the pharmaceutical industry and a commitment to contributing to the development of groundbreaking solutions that address unmet medical needs.
• Ability to adapt to changing business environments and industry trends, ensuring the 505(b)(2) portfolio remains aligned with organizational goals and market demands.
• Personal commitment to contribute, lead by example, and inspire others.
• Demonstrated success in prioritizing, managing, and executing goals with ownership and alignment to the corporate objectives.
• Travel up to 15% which may include both domestic and international travel.