Executive Director, Global Development Lead - Next Generation (Immunology & Cardiovascular)

Working with Us
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Position Summary

Global Program Leads within the ICV Global Program Leadership organization are strategic-thinking, problem-solving, and action oriented scientific leaders who bring drug development and commercialization insights to drive a sustainable pipeline of innovative medicines. GPLs serve as the “point of accountability” for their assets and are respected, matrix leaders, overseeing multi-disciplinary teams typically responsible for the development of assets from later stage Discovery (pre-GT2) through commercialization. They will foster a high performing, highly collaborative, truth-seeking team environment aimed at developing and implementing compelling, integrated asset strategies to achieve ambitious near- and long-term portfolio objectives. Each leader is accountable to therapeutic area, R&D, commercial and Company Leadership for: (i) creating a vision and defining the strategy and integrated development plan for each asset within their portfolio, (ii) developing a set of objective criteria against which each asset advancing through the pipeline will be evaluated to enable robust debate and rapid, data-driven decision making; and (iii) ensuring that only high quality and differentiated assets enter the market.

Key Responsibilities

Strategy and Execution

• Uses an understanding of disease biology, the drug development process (particularly cross-functional connectivity), and relevant late-stage challenges (e.g., trends in disease area therapeutic advances, and evolving regulatory, patient advocacy and market access environments) to create a vision for each asset, then design and execute effective development programs in support of the overall R&D portfolio goals.
• Effectively engages cross company expertise and utilizes advisory groups and governance bodies to define, revise and champion asset development strategies and implementation plans.
• Continually analyzes progress, engages in critical thinking, and asserts strong problem-solving toward delivering key data and interpretation essential for robust debate and rapid, data-driven decision making on assigned projects.
• Delivers high quality assets to commercial which have the potential for a competitive profile to address the unmet medical needs of patients and to provide favorable shareholder return.
• Ensures the process and output of the team meets established program standards (per PD&C Process expectations, within budget, on schedule, compliant, etc.), while also looking for opportunities to streamline development and enable continuous improvements without compromising quality.
• Engages senior leaders and functional area stakeholders to ensure alignment of program strategy and operational plans with functional area capabilities, and clearly communicates program risks, implications of changes in the competitive landscape and progress toward key milestones.
• Actively provides input to and drives portfolio level strategy for both internal and external opportunities.
• Participates in regulatory filings (NDA, BLA filings) as well as develops strategy for orphan drug designation.
• Engages with Health Authorities and/or Advisory Committees in the design of clinical trials and endpoints.
• Leads team to develop program strategy and clinical program, commercialization strategy plans, business case development, and understands how access, pricing and reimbursement needs for supporting value proposition will inform trial design.
• Builds and maintains collaborative relationships with external stakeholders (Opinion Leaders, Strategic Alliance Partners, Patient Advocacy Leaders, Health Authorities) and appropriately incorporates insights and advice to maximize program impact.
• Understands clinical trial operational com