Vice President, Global Program Lead Neuroscience

Role Summary

The Global Program Lead (GPL) serves as the point of accountability for one or more assets. The GPL role is accountable for leading the Global Program Team and orchestrating the design and execution of a global integrated program strategy from candidate nomination through drug development to successful launch and commercialization. The GPL develops, leads, and inspires a high performing matrix. They are 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.

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 (Opinion Leaders, 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., TPP, DEX/VAP, CI 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 CMC and 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 adequate endpoints
  • Understands clinical trial operational complexities from study start up through enrollment, quality assurance, and study readout
  • Has an active role in analysis and/or interpretation of clinical data and translation into scientific communication strategy, including publications, and commercial strategy
  • Understands and reflects the impact of VAP inputs (Early Access Review and DEX recommendations, commercial opportunity assessment, TOP/TPP requirements, and value drivers as inputs in clinical trial design
• Leadership Responsibilities
  • Inclusively collaborates across the BMS matrix with an enterprise mindset, effectively collaborating with matrix functions by building trust and driving toward the collective success of the program
  • Demonstrates enterprise mindset problem-solving and decision making, gathers diverse perspectives, assesses alternate resolutions, and makes thoughtful, informed enterprise decisions
  • Develops and leads a high performing matrix team, builds, leads and inspires high performing cross functional matrix team through a unified program strategy on behalf of our patients
  • Holds oneself and others accountable, takes initiative to address challenges, removes barriers, and holds others accountable for the collective success of the program outcomes and team collaboration
  • Demonstrates character, leads with the values, self-awareness, and humility, seeks feedback, includes integrity

Qualifications

• BS/BA required, and an advanced degree preferred (MD, PhD, MBA, PharmD, etc.) must have experience in the drug development process
• Proven demonstrated leadership capability; previous experience in building and leading a high performing team
• A minimum of 10 years in the drug development & commercialization process, Health Authorities and/or academic experience, and clinical trial design with proven progression in relevant roles
• Significant experience in related therapeutic area

Additional Requirements

• Extensive working knowledge in the end-to-end drug development process, along with expertise in one or more of the relevant areas (e.g., clinical, regulatory, project planning and management, medical, commercial development)
• Prior experience in building a development plan that was aligned with a broader strategy (TA/Franchise) and endorsed by governance
• Experience in building trusting cross-functional stakeholder partnerships in a matrix organization
• Demonstrated ability to constructively influence peers and senior leaders across the enterprise
• Working knowledge of regulations in the pharmaceutical industry (US and Global preferred)
• Demonstrated ability to effectively collaborate across geographic and functional boundaries (e.g., early development, R&D, disease strategy teams, marketing, access, etc.) and building strong external relationships
• Ability to navigate through a complex and dynamic healthcare environment
• Track record of successfully executing on large, complex projects, with a preference for successful drug trial oversight and execution
• Abreast of scientific issues as they impact business development and strategic planning
• Success in situations requiring rigorous, analytical problem solving and the ability to determine scientific opportunity and commercial targets
• Broad understanding of domestic and international issues relative to the pharmaceutical industry
• Proven agility in prioritizing and navigating competing demands
• For late development projects, prior submission experience is highly preferred