Director, CMC Asset Lead

Role Summary

The PO&T Division seeks a CMC Asset Lead who provides end-to-end leadership across asset strategy, development, supply, and lifecycle management for the CMC components of clinical programs in biologics, pharmaceuticals, or other modalities. The role oversees one or more programs from pre-clinical to Phase 2 and may manage corporate partners. This position is hybrid and based in Cambridge, MA.

Responsibilities

• Serve as the PO&T “asset owner” for early-stage programs, with full accountability for developing and delivering a five-year PO&T Asset Strategy, maintaining an 18-month rolling Tactical Plan, monitoring key program risks, and creating risk mitigation plans.
• Lead the cross-functional PO&T Asset Team, which includes representatives from process and analytical development, manufacturing, quality assurance, supply chain, device (if applicable), and regulatory CMC. Guide the team in developing and implementing both the Asset Strategy and Tactical Plan.
• Act as PO&T’s representative on Research and Development Program teams, serving as an influencer and liaison between Research, Development, and PO&T leadership.
• Proactively elevate risks with the Asset Strategy, such as those driven by other assets or line function priorities, by consulting with the PO&T Governance Committee, Research/Development governance, or corporate partners.
• Monitor the impact of asset-related activities on the annual project budget and resources and total estimated cost to commercialization. Collaborate with PO&T Line Functions to develop tactics for cost improvement and prepare business cases for major asset initiatives, securing management endorsement from the PO&T Governance Committee.
• Maintain program risk register and develop and manage mitigations to keep CMC activities off critical path.

Qualifications

• An advanced degree (PhD preferable) in a relevant biopharmaceutical discipline with at least 12 years of related experience, including both line and matrix management.
• Proven record of effective matrix leadership within program teams through all stages of the product life cycle, such as CMC line function sub-teams or other cross-functional teams in a matrix environment.
• Experience with CMC activities spanning research to IND and late-stage development, and a solid understanding of global registration processes. Technical expertise in one or more areas of bio/pharmaceutical development is required.
• Background in the healthcare, biotech, or pharmaceutical industry, with demonstrated understanding of cross-functional interdependencies among Research, Development, commercial, regulatory, and finance functions.
• Strong strategic, organizational, and relationship-building skills.
• Ability to lead, motivate, and influence strategic direction without direct authority, leveraging and developing diverse perspectives and ideas from matrix teams and other stakeholders.
• Excellent communication, negotiation, problem-solving, and decision-making skills.
• Demonstrated ability to identify critical program risks and implement strategic or tactical mitigation plans to reduce risk, cost, and reputational impact to Biogen.