VP, Global Program Lead, Late Development Immunology

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Position Title: VP, Global Program Lead, Late Development Immunology

Global Program Lead Role Summary:

The Global Program Lead (GPL) serves as the “point of accountability” for one or more assets.  The late GPL role is accountable for leading the Global Program Team and orchestrating the design and execution of a global integrated program strategy through drug development to successful launch and commercialization. The GPL develops, leads, and inspires a high performing matrix. The GPL is responsible for cross-functional stakeholder relationships and input to ensure end-to-end understanding of upstream and downstream alignment and business implications for the strategy, and its evolution as emerging data and competitive insights unfold.  

Technical/Functional Responsibilities:

Develops and manages product strategy and late drug development program to ensure approval and commercial success

• Defines and executes the strategic integrated development plan (IDP) in partnership with the cross functional GPT members

• Participates in regulatory filings (NDA, BLA filings) as well as develops strategy for orphan drug designation

• Engages with Health Authorities and/or Advisory Committees

• 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 (Key Opinion Leaders [KOLs], Strategic Alliance Partners, Patient Advocacy Leaders, Health Authorities) and appropriately incorporates insights and advice to maximize program impact

• Actively supports Investor Relations and Public Affairs in managing external BMS communications

Integrates commercialization inputs and deliverables to design the late program strategy that enables approval of a meaningfully differentiated asset with potential to maximize asset value

• Understands necessary commercial inputs needed to inform the end-to-end development process leading to regulatory approval and successful commercialization 

• Integrates market inputs (e.g., Target Opportunity and Product Profiles, Market Access & Value, Competitive Intelligence insights) into the integrated development plan, incl., clinical plans and labeling strategy; Appreciates translation of clinical data into claims and considerations for label development

• Understands and contributes to development of forecasts and investment scenarios, how to assess risk and conduct valuations, and implications for decision making

• Contributes to the development of brand hallmarks and brand strategy (generic name, brand name, logo, brand colors, positioning, messaging, campaign, segmentation, promotional strategy) understanding the relationship to clinical trial design

• In partnership with Medical Affairs, supports development of KOL plans and engagements, and leverages KOL input in context of development programs and communicating evidence

• Supports commercial needs and recommendations to guide Chemistry, Manufacturing, and Controls (CMC) and Global Product Strategy (GPS) on trade packaging and commercial product

Clinical Trial Design, Execution, and Interpretation

• Utilizes various resources to design clinical trials that are competitively differentiating (e.g., competitive intelligence knowledge, KOL input)

• Actively participates with Health Authorities in finalizing clinical design and