Executive Director, Global Program Lead, Early Development Oncology - Targeted Therapies

Position Summary

Global Program Leads at BMS are strategic-thinking, problem-solving, and action-oriented business 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.

Key Responsibilities

• 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.
• 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.
• 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 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).
• 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, including, clinical plans and labeling strategy; Appreciates translation of clinical data into claims and considerations for label development.
• Contributes to the 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.
• Supports commercial needs and recommendations to guide CMC and GPS on trade packaging and commercial product.

Qualifications & Experience

• MD, PhD, DVM, PharmD, MBA or equivalent advanced degree of relevance, with experience in the drug development process.
• 10+ years of experience in the drug development process and leadership experience in academic or industry setting, including education where applicable.
• Expertise in the drug development process with in-depth know how and experience in matrix team leadership, relevant regulatory expectations, and overall drug development and commercialization.
• Successful track record of leading through influence and working across complex, global organizational matrix.
• Significant experience in cell therapy preferred, with demonstrated understanding of the role of basic biology, pharmaceutical optimization, translational medicine, and clinical pharmacology, including exposure-response relationships and dose selection.
• Strong understanding of relevant regulatory health authority expectations and regulations for drug development and impact on commercialization.
• Working knowledge of all functional areas of exploratory development, including chemistry/biochemistry, biology, toxicology, CMC, translational medicine, early clinical development, etc.
• Demonstrated scientific acumen and mechanistic understanding of pharmacology and disease biology.
• Ability to create a clear purpose, global vision, strategies and key priorities for competing successfully in the evolving pharmaceutical and health care industry.
• Demonstrated ability to lead cross-functional team to execute Development Plans which have global perspective and focus on product differentiation, including opportunities for data driven acceleration.
• Demonstrated ability to objectively assess complex but relatively sparse data sets, make informed decisions and take action in the face of uncertainty.
• Demonstrated ability to present complex programs to senior leaders and influence decision making.
• Experience in successfully managing and leading high performing, cross-functional matrix teams or complex multi-functional organizations.
• Demonstrated ability to coach and mentor others to enhance performance and/or facilitate career progression.
• Ability to effectively and seamlessly multi-task, and prioritize across multiple development assets, with complex strategies and accelerated development timelines.
• Demonstrated ability to successfully and effectively cooperate, collaborate and work across functions.
• Demonstrated ability to advise and participate in business development due-diligence evaluations and transaction recommendations.