Director Observational Research

📋 Description

• • Lead strategic planning and operational performance for observational research initiatives within Amgen’s Oncology therapeutic area, aligning with the Center for Observational Research (CfOR) mission to generate real-world evidence (RWE) that supports product development and commercialization.
• • Design and execute observational research studies to generate evidence on disease frequency, clinical burden, natural history, treatment utilization, cost, and therapeutic safety and efficacy to inform critical business decisions across the product lifecycle.
• • Identify opportunities to substitute or complement interventional clinical trials with non-interventional observational research to reduce development time and costs.
• • Influence cross-functional stakeholders—including clinical, regulatory, medical affairs, and commercial teams—to prioritize and integrate observational research into high-impact strategic questions.
• • Leverage real-world data and advanced analytical methodologies to support evidence generation for regulatory submissions, label expansions, post-marketing commitments, and product differentiation.
• • Serve as a scientific leader and first or contributing author on peer-reviewed publications and internal reports that advance Amgen’s scientific reputation and patient impact.
• • Manage and mentor a team of observational research scientists, fostering professional development and high-performance culture within CfOR.
• • Collaborate with internal and external partners, including academic institutions and industry experts, to design, conduct, interpret, and publish high-quality observational studies.
• • Track organizational and functional priorities, ensuring optimal allocation of resources to meet strategic objectives across the oncology asset portfolio.
• • Contribute to the innovation and advancement of epidemiological methods and analytical capabilities within CfOR to maintain industry leadership in observational research.
• • Develop and maintain strong relationships with senior leadership across Amgen to align observational research strategy with corporate and therapeutic area goals.
• • Participate in the development of both product-specific and CfOR-wide strategies to ensure observational research remains a critical component of Amgen’s evidence-generation framework.
• • Ensure compliance with regulatory and reimbursement requirements through robust study design and evidence generation that meets evolving global standards for RWE.
• • Champion best practices in data integrity, ethical conduct, and transparency in all observational research activities conducted under CfOR’s purview.