Job Description
General Summary:
The Senior Director, BSMO Immunology Disease Area Lead represents BSMO on the Immunology Disease Strategy Team (DST). The incumbent provides strategic and operational leadership for all BSMO activities supporting programs across the Immunology portfolio, and is accountable for driving an integrated BSMO program strategy, alignment, and execution across Pharmaceutical Sciences, Biopharmaceutical Sciences, CMTO, Quality, Supply Chain, Regulatory, Finance, and other relevant functions to support development, launch, and lifecycle management of disease-area products. As a core member of the Immunology DST, this leader partners cross-functionally to translate disease strategy into executable technical and operational plans that enable reliable, compliant delivery of biologic medicines to patients with serious immune-mediated disease. By sitting on the DST, this role ensures BSMO priorities and resources are aligned with the broader disease-area strategy, that BSMO has visibility to disease-area developments, and that the DST understands BSMO activities and capabilities.
Key Duties and Responsibilities:
Lead the development and execution of the BSMO program strategy for Immunology programs, aligned with disease, clinical, and commercial strategies.
Serve as the BSMO representative on the Immunology DST, supporting governance, planning, and risk discussions.
Provide integrated leadership across Pharmaceutical Sciences, Biopharmaceutical Sciences, CMTO, Quality, Supply Chain, and external partners to ensure program readiness.
Partner cross-functionally within BSMO to integrate plans to develop and commercialize biologic disease-area products, ensuring regulatory compliance.
Support biologics CMC regulatory strategy and submissions in partnership with Regulatory, including IND/IMPD and BLA/MAA content and health-authority interactions as needed.
Lead cross-functional BSMO teams to deliver against program milestones in a matrixed environment, requiring a robust understanding of each BSMO function's role.
Build effective partnerships with internal stakeholders within BSMO and more broadly across the enterprise.
Identify and manage program-level technical, operational, and supply risks for biologic products, ensuring appropriate escalation and mitigation planning.
Own BSMO program budgets, forecasts, and resource plans, aligning with functional and DST priorities (AOP/LRP).
Track and communicate program status, KPIs, and risks to BSMO and DST leadership.
Required Knowledge and Skills: (biologics-weighted)
Strong expertise in biologics development and manufacturing across the lifecycle, including cell-line/upstream cell culture, downstream purification, drug substance, formulation, drug product/fill-finish, and device/combination-product considerations where applicable.
Working command of biologics CMC fundamentals: process and analytical development, control strategy, product and process characterization, comparability and change management , and process validation/PPQ.
Understanding of biologics-specific technical risks — product/process sensitivity, aggregation and immunogenicity, glycosylation and other critical quality attributes, stability, and cold-chain requirements.
Solid understanding of CMC, Quality/GMP, Regulatory, and Supply Chain requirements for biologic products, including inspection readiness.
Experience with external manufacturing / CDMO oversight for biologic drug substance and drug product, including technology transfer and scale-up.
Capability to build cross-functional alignment across R&D, Pharmaceutical/Biopharmaceutical Sciences, Regulatory, Finance, Commercial, and Manufacturing partners.
Demonstrated expertise in critical thinking, influence, negotiation, problem-solving, strategic thinking, and leadership in a matrix environment; proven ability to influence areas not under direct control.
Excellent verbal, written, and presentation skills.
Education and Experience:
Advanced degree…