Director - Clinical Research Physician, GPS Medical - Cardiometabolic Health

Eli LillyUS, Indianapolis INonsite$201k–$361kView the original posting at Eli Lilly ↗

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. The Clinical Research Physician (CRP) in GPS Medical has responsibilities associated with the development, management, execution, and oversight of all aspects of the safety program for one (or more) asset(s) throughout the product(s’) life cycle. This individual plays a major role in coordinating technical functions within GPS to facilitate these responsibilities The individual is accountable for collaborative contributions and partnership with the integrated development or product team to deliver on these safety commitments while demonstrating GPS expertise and leadership. The CRP is the Lilly GPS Medical representative for both internal and external stakeholders regarding a product or developmental therapeutic agent, interacting as prescribed in corporate guidelines, standards, and policies. Individualized responsibilities for a particular product or project will be discussed and agreed at an individual level. Primary Responsibilities: Key GPS Medical Activities and Safety Oversight Provides GPS Medical leadership and ensures proactive pharmacovigilance (PV) for assigned product(s): In early phase development, performs and/or contributes to medical review of individual case safety reports for completeness and accuracy, providing company causality assessment and requests for follow up, if needed. Provides medical oversight of surveillance activities, safety signal decisions and risk management actions to be taken, including communication and/or escalation to appropriate internal or external stakeholders (e.g., GPS leadership, governance committees, development teams, Regulators) Monitors various safety activities for impact to Core Safety Information and Core Risk Minimization activities Builds collaborative working relationships to ensure full cooperation; guides effective and efficient drug development, and ensures high-quality medical evaluation of safety data Responsible for the oversight and actions related to regulatory queries on safety-related topics Acts as the GPS Medical lead at the time of acquisitions and integrations of new companies/assets, partnering with internal and external stakeholders to ensure seamless continuity of safety surveillance activities. Demonstrates advanced knowledge of safety concepts, per ICH, US and international regulation/guidelines and GxP. Synthesizes complex data into actionable insights and translates technical issues into strategic discussions Acts as the Lilly GPS Medical Representative for both internal and external stakeholders, interacting as prescribed in corporate guidelines and policies. Builds strong relationships with key stakeholders, representing and championing the role of safety in the organization (including): Product Team Leaders and Business Unit Leadership Regulatory (including Device and CMC regulatory) Affiliate Medical Leadership/Clinical Research Physicians COE and Discovery and Clinical Research External Opinion Leaders Reviews and comments on external regulatory policy and trends affecting Global Patient Safety. Represents GPS Medical in inspection and audit activities for assigned program(s) May serve on safety advisory hub committees and/or consultative cross-functional bodies providing input and guidance to clinical development teams on select safety topics May serve as a member of the Quality-GPS (AE/PC and Device) safety

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