As a Director, CMC Product Development, you will bring together scientific insight, enterprise perspective, and cross-functional leadership to help transform promising assets into differentiated medicines. As a key member of the Asset Strategy Team (AST) and leader of the CMC team, you will develop and drive an integrated CMC strategy that enables the overarching asset strategy. Serving as the single CMC spokesperson and integrator for the asset, you will connect expertise across the enterprise to drive alignment, informed decisions, and successful product development. This highly visible role offers a unique opportunity to lead multidisciplinary teams, influence asset-level strategy and investment decisions, and engage with senior leaders, external partners, and global health authorities from late discovery through clinical development and transfer to commercial manufacturing. Through scientific judgment, enterprise leadership, and matrix influence, you will navigate complexity, manage risks, align stakeholders, and help advance innovative therapies that meaningfully impact patients’ lives.

0-3 direct reports. Scope: from late-stage Discovery through clinical development to technology and process transfer to commercial manufacturing sites.

Responsibilities

• Serve as the CMC leader, integrator, and spokesperson on the Asset Strategy Team (AST), connecting CMC strategy with the overarching asset strategy and ensuring clear, timely, and effective communication across the AST, CMC functions, and key stakeholders.
• Lead and inspire highly matrixed, cross-functional Product Presentation and Device Strategy teams (PPDST) and CMC teams, creating clarity of purpose, aligning diverse perspectives, facilitating effective decision-making, and building a collaborative and accountable team culture.
• Develop, communicate, and drive the integrated CMC strategy and development plan for complex assets, translating scientific and technical considerations into clear strategic choices, priorities, timelines, risks, and recommendations for teams and senior leaders.
• Communicate with impact across organizational levels, translating complex CMC topics into clear messages and recommendations, proactively surfacing risks and opportunities, and enabling informed decisions by asset teams, senior leaders, and governance bodies.
• Act as a connector across the organization and throughout the development lifecycle, from late discovery through clinical development and technology transfer to commercial manufacturing. Build strong relationships and alignment across CMC, Clinical, Regulatory, Quality, Operations, Preclinical Safety, ADME, Commercial, external partners, and other stakeholders, while mentoring and developing other CMC leaders and team members.
• Build and sustain trust and credibility with team members, stakeholders, and leadership, leading through natural authority, scientific credibility, sound judgment, and influence rather than hierarchy. Leverage that trust and influence to align priorities, resources, and timelines across functions, navigate ambiguity, resolve issues, foster open dialogue, and build alignment around decisions that successfully advance the asset.
• Shape and strengthen team culture by promoting scientific excellence, inclusion, collaboration, candid dialogue, entrepreneurial thinking, accountability, and a strong sense of shared ownership for the success of the asset and broader portfolio.
• Lead a portfolio of programs across multiple modalities, which may include small molecules, biologics, antibody-drug conjugates, cell and gene therapies, toxins, devices, and implants. Program assignments will consider the CMC PDD’s experience and qualifications to set them up for success, while providing opportunities to broaden their experience, build new capabilities, and grow in the role.