CMC Product Management Lead (Sr. Director)

Astellas is a global life sciences company committed to developing transformative therapies for patients in areas of high unmet medical need. The CMC Product Management Lead is accountable for CMC activities across the asset lifecycle, from development candidate nomination through registration, launch, and lifecycle transition. The role leads cross-functional teams, shapes asset strategy, manages risks and resources, and ensures high-quality product development, manufacturing, regulatory, quality, supply, and partner execution.

Responsibilities:

• Define, own and implement the integrated CMC asset strategy, ensuring alignment with target product profile, quality target product profile, clinical development plan, regulatory strategy, commercialization and launch plan, and lifecycle objectives
• Serve as the primary product development, manufacturing and supply representative on the asset maximization team, providing strategic input into asset plans, governance decisions, investment choices, and differentiating VALUE creation opportunities
• Holds accountability for the product strategy and product innovation ensuring alignment with the quality target product profile and lifecycle objectives
• Accountable for managing and optimizing COGM to enhance product VALUE, profitability, and lifecycle sustainability
• Translate complex scientific, technical, CMC regulatory, quality, manufacturing, supply chain, and commercial considerations into clear options, trade-offs, and implications for timelines, cost, quality, risk, and asset VALUE
• Lead the cross-functional Product VALUE Team, integrating drug substance, drug product, analytical, CMC regulatory, quality, manufacturing, supply chain, finance, intellectual property and external partner workstreams
• Convert the integrated CMC asset strategy into fit-for-purpose integrated plans with clear milestones, dependencies, resource requirements, budget assumptions, risk mitigation pathways, and decision points
• Lead the manufacturing site selection ensuring alignment with the clinical development plan, commercialization and launch plans as well as with the PDM Supply Network Strategy
• Maintain clear end-to-end accountability for the overall control strategy including integrated CMC risk management of the asset across the patient axis in accordance with ICH Q8-Q11 principles and enterprise criteria
• Drive delivery of phase-appropriate CMC development strategies consistent with Asset Maximization Team goals, regulatory expectations, launch readiness, and enterprise portfolio priorities
• Manage integrated CMC and asset-level budget and resource forecasts in partnership with functional leaders, ensuring disciplined prioritization and investment quality
• Co-develop CMC regulatory strategy in close partnership with CMC regulatory, representing product development and CMC perspectives in health authority meetings and pre-submission interactions
• Ensure CMC activities, control strategy, submission content, product risk assessments, and regulatory filing roadmaps are scientifically robust, phase-appropriate, compliant, and aligned to quality expectations
• Maintain accountability for the quality, completeness, and strategic coherence of CMC submission content, including Module 3 and equivalent regional requirements
• Serve as the primary CMC interface to governance bodies, senior leaders, and alliance governance; present concise recommendations, decision options, risks, and implications for asset VALUE
• Drive alignment across functions, geographies, regions, and partners by eliminating silos, accelerating decision-making, and ensuring consistent execution against the integrated strategy
• Anticipate and resolve cross-functional risks and issues, escalating transparently through governance when decisions, resources, or trade-offs are required
• Represent the asset or program externally with alliance partners, CDMOs, vendors, regulators, key experts, and relevant stakeholder communities, ensuring credible, compliant, and consistent communication
• Contribute to developing enterprise capability by mentoring POD and VALUE team members, strengthening team effectiveness, and embedding high standards for execution, governance, quality, and VALUE creation and delivery
• Partner with functional leaders to support growth, development, and readiness of team members contributing to asset and product development outcomes

Requirements:

• Advanced degree in sciences, engineering, pharmaceutical sciences, or a related discipline
• Minimum of 8 years of relevant experience with a PhD, 12 years with an MS, or 15 years with a BS, including significant experience leading complex, global, matrixed drug development programs or strategic assets
• Demonstrated success in product development, CMC leadership, enterprise program leadership, or asset leadership with accountability for strategy, execution, budget, governance, and cross-functional outcomes
• Broad understanding of the end-to-end development continuum, including CMC, technical development, clinical development, regulatory strategy, manufacturing, quality, supply chain, launch readiness, commercialization and LOE management
• Demonstrated strategic understanding of the competitive landscape, including competitor pipelines, market dynamics, and key differentiation opportunities
• Strong financial and business acumen, including experience with budget stewardship, investment decisions, resource prioritization, business case development, enhancing supply chain performance and resilience and VALUE optimization
• Demonstrates strong business development acumen, understands how to build and manage strategic alliances, and proactively applies industry benchmarking and competitive intelligence to shape asset, portfolio, and manufacturing strategies
• Track record of influencing senior leaders, governance bodies, investment forums, external partners, and health authorities in high-stakes, ambiguous environments
• Experience leading alliance relationships, outsourced networks, CDMOs, vendors, or other external partnerships in support of program execution
• Exceptional communication, synthesis, negotiation, stakeholder management, and team leadership skills
• doctoral-level training
• Experience leading assets from early development through regulatory approvals, launch, or post-approval lifecycle management
• Executive leadership and presence presenting in portfolio governance, investment committee, executive leadership, or board-adjacent decision forums
• Demonstrated ability to operate credibly across multiple therapeutic areas, modalities, or technical platforms
• Proven success building high-performing teams delivering outcomes and strengthening enterprise leadership capability
• Experience managing seamless transition from development to commercial operations, including product knowledge transfer, lifecycle planning, commercial supply readiness, and product discontinuation