Executive Director - Clinical Research Physician - GPS Medical

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.  Clinical Research Physician, GPS Medical Purpose 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.

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Not all listed responsibilities will be applicable to all GPS Medical CRP roles. 1. Key GPS Medical Activities and Safety Oversight ▪ Provides GPS Medical leadership and ensures proactive pharmacovigilance (PV) for assigned product(s): i. 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. ii. 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) iii. Monitors various safety activities for impact to Core Safety Information and Core Risk Minimization activities i v. Builds collaborative working relationships to ensure full cooperation; guides effective and efficient drug development, and ensures high-quality medical evaluation of safety data v. 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 2. 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): i. Product Team Leaders and Business Unit Leadership ii. Regulatory (including Device and CMC regulatory) iii. Affiliate Medical Leadership/Clinical Research Physicians iv. COE and