Director, Global Labeling Data Strategy Lead

As a member of the GL leadership team, the director, GL data strategy and team assess and communicate the impact of key clinical endpoints on a future label. You will influence by articulating how agency advice and precedence and the competitive landscape support or require modifications to the design to deliver desired label outcomes. The position then maps the future label to potential advertising and promotion opportunities and tracks impact of recommendations to successful product promotion. Additionally, this position may identify labeling claims that could result from a proposed protocol. Assessment must occur early in product development activities and before endorsement of the pivotal protocol. Keeping the end in mind, impact analysis should include: analysis of endpoints, inclusion criteria, exclusion criteria, major market and key secondary market regulatory precedence and standard of care, experience gathered from other internal programs and HA requests for information along with experience gathered from competitors. The output can inform GL Strategists, Regulatory (global and region), Commercial and Clinical stakeholders regarding the trade-offs between the proposed protocol design and impact on labeling prior to committing to a protocol design and/or early development labeling strategy. For key marketed products, the director, GL data strategy/team identifies potential ways to leverage existing data to improve product differentiation based on regulatory and business goals. Using established methodology and tools, the data strategy team has the potential to also support response generation for other GRA strategic questions as requested by GRAST/GRALT. This position provides leadership, coaching, innovation and technical expertise, a keen understanding of country-specific regulatory requirements and the ability to connect data with strategy to meet company objectives. Main Accountabilities and responsibilties: - Lead data strategy assessment team across all TAs and put in place an E2E product information strategy during entire lifecycle. - Assess the impact of key endpoints on label using competitive intelligence and data analysis, regulatory precedence and knowledge of study design, development and trial conduct. - Utilize findings to make recommendations which inform sound decisions when developing labeling and/or regulatory strategies. - Create a natural linkage to global ad promo. - Liaise with GRA Regions, commercial development and commercial ops to ensure appropriate regulatory review of core product material and local ad promo review process and system/tools. - Use creative problem-solving and facilitate communication to key stakeholders by clearly explaining the science/regulatory perspective. - Act as a resource across GRA to provide insight for challenging questions based on established and proven methodology. - Build technology solutions that power future analysis and provides support across GRA through use of tools and established methodology. Qualifications and Experience: - University degree (4 year degree) in Life Sciences or Data Analysis; advance degree preferred. - Minimum of 12 years of biotech/pharmaceutical industry experience or a combination of 5+year’s experience in regulatoyr and/or related data analysis or clinical development experience

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