Director, Small Molecule- Technical Product Leader (TPL)

The Director, Technical Product Leader (TPL) Leadership position in the Small Molecule Science and Technology (SM S&T) organization within our Manufacturing Division is a full-time role and is accountable for leading the Development Commercialization Team (DCT) at Line of Sight to Commercial Product Definition. This pivotal role encompasses both technical, execution and strategic responsibilities, as it entails guiding drug product candidates from late-stage development to launch and transition to supply, and subsequently as TPL supporting Value Chain Management Team (VCMT) in realization of product lifecycle strategy, in line with enterprise priorities. As Technical Product Leader (TPL) in our Manufacturing Division, the leader is: Accountable to the Development Commercialization Review Committee (DCRC) for delivering a fully integrated stage-appropriate development and commercialization strategy which yields the target commercial product. Leads the cross-functional DCT, critically assessing all team deliverables & fostering a learning and collaborative environment. Prioritizes, interrogates, and mitigates risks across all factors that may impact technical, operational & regulatory success or timelines. Analyzes and develops innovative solutions to unforeseen circumstances. Responsible for end-to-end technical product leadership (TPL) and oversight of the on-time execution of DCT deliverables inclusive of robust processes & analytics, an integrated control strategy, successful tech transfer packages, filing and approval, and a robust commercial supply chain to achieve launch on time and uninterrupted long-term supply. Represents CMC and effectively communicates across the governance bodies, stakeholders, and team to drive outcomes/decisions through influence, advocacy, & negotiation with an enterprise mindset. As the CMC representative, influences and challenges the xDT strategy to ensure a robust CMC strategy is achieved. Identifies options to balance Speed/Cost/Robustness & achieve target commercial product. Responsible for end-to-end technical product leadership (TPL) and oversight of the on-time execution of VCMT deliverables inclusive of new nodes and filings. Core Competencies Required for the Role: Technical Depth and Breadth: Exhibits the necessary technical depth and breadth to add substantial value to the business. Recognized as a credible technical leader through demonstrated scientific excellence in at least one CMC function and ability to navigate through uncertainty to favorable outcomes. Demonstrated expertise of technical aspects and interdependence across Drug Substance, Drug Product, Analytical, Device, Packaging, Regulatory, Quality, and Supply Chain from early development through life cycle of the program. Deep understanding of connectivity between clinical, CMC, and HH to successfully launch a new product. Strategic Thinking/Enterprise Thinking: Understands and can articulate the "big" picture, thinks strategically, and demonstrates customer orientation. Demonstrated ability to know how to ask the right questions to drive critical conversations to the best decision for the enterprise, considering options which balance speed, cost, and robustness. Capable of asking the right questions to drive critical conversations to the best decision for the enterprise, considering options which balance speed, cost and robustness. Challenges DCT and VCMT members to think beyond their functional areas for the broader interests of the company and the patients we serve. Problem Solving: Gathers and analyzes data and effectively responds to new or complex situations, developing creative and innovative solutions to solve and mitigate problems. Leverages scientific expertise and growth mindset to interrogate data and fosters scientific debate within teams to enable innovative and robust problem solving. Approaches problem solving and project progression logically and in alignment with overall business needs.