Job at a glance
Are you ready to build the real-world evidence foundation that unlocks US pricing and access for breakthrough therapies? Can you turn complex data into clear, timely insights that shape value stories and speed innovative medicines to patients? As Director, Real-World Evidence - Early Assets, you will work upstream of launch to define the US evidence strategy that influences critical decisions well before approval.Based in Wilmington, DE and partnered closely with US Medical, US Market Access, and US Access Strategy, you will lead the generation of disease burden, natural history, treatment patterns, and unmet-need evidence that informs US Pricing and US Access Strategy.
Your work will be tightly aligned with global counterparts so US needs are embedded early in Integrated Evidence Plans and reflected in global strategy.You will thrive in a high-energy, outcomes-focused environment that values scientific rigor and commercial impact. With autonomy to act and the backing of expert, cross-functional teams, you will pilot modern methods and responsibly adopt AI-enabled tools to elevate the quality, speed, and credibility of our evidence.Accountabilities:Integrated Evidence Planning and US Pricing and Access Input: Embed US RWE needs into Integrated Evidence Plans for assigned pre-launch assets and shape the early value story that informs US Pricing and US Access Strategy.Pre-Launch Evidence Leadership: Generate burden-of-illness, unmet-need, and comparative context evidence sequenced to pre-launch decision milestones, ensuring outputs are fit-for-purpose for US decision-makers.RWE Study Design and Execution: Lead natural history and disease-burden studies, observational and retrospective analyses, target trial emulations, prospective registries, and pragmatic effectiveness work using advanced causal methods with rigorous bias mitigation.Real-World Data Stewardship: Identify and secure fit-for-purpose data sources (claims, EMR, registries, linked datasets), establish data foundations for assets without an existing footprint, and champion representativeness and health equity in data selection and study design.US Healthcare Landscape Stewardship: Continuously scan payer, policy, quality measure, and value-based care trends; translate insights into evidence priorities and study designs that anticipate emerging needs.Pricing and Access Evidence (Pre-Launch): Deliver early economic and burden-of-illness analyses that inform US pricing hypotheses and US access planning, building the foundation for future AMCP Dossiers, formulary submissions, and contracting.Global Alignment: Partner with Global Medical Evidence, Health Economics and Payer Evidence, and Market Access counterparts to align study design and data sources with the Integrated Evidence Plan and inform HTA submissions, economic models, and value dossiers.External Partnerships in Evidence Generation: Cultivate collaborations with academia, learning health systems, real-world data providers, patient advocacy groups, and relevant registries to access novel data, co-design studies, and amplify scientific credibility.Launch Transition and Handoff: As assets approach approval, prepare a seamless transition of the evidence base to in-line teams, ensuring continuity for Field Medical enablement and implementation partners.Responsible AI Adoption: Apply AI/ML tools responsibly in RWE workflows (e.g., NLP, automated data quality checks, signal detection), evaluate model validity and bias, and contribute to capability building through documented methods and peer learning.Compliance, Methods and Research Governance: Adhere to research governance, data privacy, GCP, and SOPs; contribute to internal methods development and peer review to uphold scientific quality and integrity.
Essential Skills/Experience:Education. Advanced degree (PhD, PharmD, MD, or relevant Master's) in Epidemiology, Health Services Research, Health Economics, Outcomes Research, Biostatistics, or a related field.Experience