Director - Global Patient Safety Pharmacoepidemiologist

Purpose

• Reports into GPS Medical and provides scientific, data-driven guidance to meet strategic objectives in generating data that characterize the safety profile of Lilly products.
• Contributes to cross-functional teams responsible for generating primary data or analyzing secondary data sources to assess the benefit-risk profile of Lilly products.
• Supports the development and execution of risk management plans.
• Identifies and evaluates potential safety signals.
• Addresses safety questions from regulators.
• Designs and conducts pharmacoepidemiology studies.
• May also have some in-line or project-level supervisory responsibilities.

Primary Responsibilities

• This job description gives a general overview of the job requirements at the time it was prepared.
• Requirements may change over time and may include additional responsibilities not described here.
• Not all responsibilities apply to all GPS PE roles.
• Consult your supervisor about your actual responsibilities and any related duties.

• Study Design & Execution
• Collaborate within a cross-functional team and lead the design and execution of observational studies, ensuring high-quality, scientifically rigorous study proposals, protocols, statistical analysis plans, clinical study reports, abstracts/publications, and presentations.
• Contribute to the Risk Management Strategy/Real World Evidence Safety Strategy for assigned molecule(s).
• Design, coordinate, and implement observational epidemiological studies (including secondary use dataset studies) on disease burden, natural history of disease, and background rates for identified or potential drug risks.
• Develop new methodologies and appropriately use pharmacoepidemiologic tools to identify and analyze potential safety signals.
• Apply in-depth epidemiologic methods to complex research questions.
• Lead pharmacoepidemiology studies internally when appropriate, and collaborate or contract with external investigators and Third-Party Organizations as needed.
• Provide scientific expertise in interpreting and communicating study results.
• Collaborate on strategic analytic tools that support disease state characterization, signal detection, clarification, and evaluation using multiple data sources (e.g., spontaneous reports, health claims, electronic health records).
• Partner on new standardized analytic methods for selected regulatory safety documents and submissions (e.g., PBRER/PSUR, ISS, product labels).
• Regulatory Support and Public Health Impact
• Provide input into regulatory documents such as Risk Management Plans, Periodic Benefit-Risk Evaluation Reports, and responses to regulatory queries.
• Provide epidemiological expertise on signal detection and signal management for the portfolio.
• Collect and analyze patient population data from literature and other sources to assess disease burden in support of regulatory submissions (e.g., Orphan Drug Applications, Pediatric Investigation Plans, Pediatric Study Plans).
• Represent Lilly and coordinate its presence in external epidemiology or drug safety groups.
• Stay current on regulatory activities (e.g., FDA, EMA) related to epidemiology.
• Use external contacts for scientific intelligence through benchmarking projects and forums.
• Data Source Expertise
• Maintain a deep understanding of RWD and methodology, including digital tools.
• Demonstrate knowledge of relevant global regulatory requirements and practices.
• Act as subject matter expert in developing and maintaining procedures and required tools in the quality system as they relate to epidemiology.
• Develop analytic tools that support disease state characterization, signal detection, clarification, and evaluation using multiple data sources (e.g., spontaneous reports, health claims, electronic health records).
• Lifecycle Management
• Support strategy across the product lifecycle through evidence generation.
• Contribute to the Risk Management Strategy/RWE Safety Strategy for a molecule.
• Design, execute, and interpret pharmacoepidemiology studies, including design and review of protocols, SAPs, final study reports, presentations, and manuscripts.
• Lead pharmacoepidemiology studies internally when appropriate, and collaborate or contract with external investigators and CROs as needed.
• Training, Coaching, Mentoring
• Provide training, coaching, and mentorship on effective PV strategies, sharing experience and knowledge to advance the goals of the GPS department and the wider enterprise.
• Maintain compliance with the Lilly Red Book, corporate policies, and the Lilly Research Laboratories and Global Patient Safety curriculum.
• Maintain compliance with the Lilly Corporate Integrity Agreement.
• People Management
• Foster a collaborative working environment that maintains a Team Lilly culture focused on inclusion, innovation, acceleration, and delivery.
• Recruit, mentor, develop, and retain top scientific and drug development talent.
• Ensure staff comply with company policies and procedures.
• Understand and Support the QPPV Role
• Understand the roles and responsibilities of the European Union Qualified Person (QPPV).
• Ensure the support needed for the Qualified Person to fulfill all of their legal responsibilities.

Minimum Qualification Requirements

• Graduate-level degree in a health-related field and 3+ years of experience in scientific research or the pharmaceutical industry.
• Experience conducting epidemiology studies, including analyzing data and interpreting results from clinical and epidemiology studies.
• Experience with AI-driven programming techniques to enhance pharmacoepidemiologic study design, data analysis, and signal detection activities.

Other Information/Additional Preferences

• Education: MPH, or preferably a PhD in Epidemiology or a related Public Health field.
• High-level knowledge of global regulations on drug safety and adverse event reporting.
• Ability to learn and apply technical knowledge to meet changing project needs.
• Excellent computer skills and knowledge of statistical software packages for analyzing epidemiological data.
• Highly effective written and verbal communication skills.
• Ability to work on multiple projects and function effectively in a fast-paced, matrixed environment.
• Ability to prioritize tasks and shift priorities rapidly to meet tight deadlines.
• Strong analytical skills and the ability to apply statistical and epidemiological methodology in research projects.
• Understanding of risk management strategies and risk minimization programs.
• Ability to influence others, both cross-functionally and within the function, to create a positive working environment.
• Excellent teamwork skills.
• Experience using longitudinal national databases, claims databases, or electronic medical records (e.g., GPRD) for epidemiologic research.
• Strategic thinker with proven project execution and innovation experience.

Additional information

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $153,000 - $264,000

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.

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