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Full time

6 days ago
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Job summary

Lilly is seeking an Executive Director - Clinical Research Physician for GPS Medical to lead pharmacovigilance and safety oversight across assets throughout the product lifecycle. The CRP collaborates with development teams, external stakeholders, and GPS leadership to ensure high-quality medical evaluation of safety data.

Actual compensation will depend on education, experience, and geographic location. The anticipated wage is $243,000 - $356,400 per year, with eligible bonuses and a

Qualifications

  • Provides GPS Medical leadership in pharmacovigilance for assigned products.
  • Oversees safety data review and regulatory communications.
  • Collaborates with cross-functional teams to support drug development.

Responsibilities

  • Provides GPS Medical leadership and ensures proactive pharmacovigilance for assigned product(s).
  • Provides medical oversight of surveillance activities, safety signal decisions and risk management actions.
  • Monitors various safety activities for impact to Core Safety Information and Core Risk Minimization.

Skills

Pharmacovigilance
Medical oversight
Regulatory communication
Cross-functional collaboration

Job description

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.

Primary Responsibilities
  1. 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 i
      • 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

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $243,000 - $356,400. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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