Advisor / Sr. Advisor - Pk/Pd & Pharmacometrics

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.

About the Team

The Global Pharmacokinetics/Pharmacodynamics and Pharmacometrics (PK/PD & PMx) Department serves as the functional leader in research and development across the value chain, from preclinical lead molecule identification through clinical post-approval. Our mission is to accelerate the development of innovative medicines by applying mechanistic reasoning and quantitative modeling to complex systems. We partner across disciplines to simplify and enable critical decisions. We are leaders in model-informed drug discovery and development. Using deep quantitative thinking, we work best with hard questions, and our insight shapes the medicines that reach patients.

The PMx team operates across all phases of drug development and serves as a strategic scientific partner to project teams, regulatory functions, and senior leadership. We are currently investing in automation, AI/ML integration, and standardized modeling workflows to accelerate timelines and expand our impact.

We seek dynamic, curious, and collaborative quantitative scientists ready to engage and work on life-changing therapies for patients. This role is for a scientist who wants to own the modeling and simulation on real programs and be trusted with the answer. You will develop and apply population PK and PK/PD models independently, author the analysis plans and reports behind them, and work as a scientific partner and not as an analysis service. Your work will span multiple programs within PK/PD & PMx. You will take it to project teams and department forums, and build the judgment that turns a modeling result into a development decision.

Key Responsibilities

Scientific and technical delivery

• Independently develop, evaluate, and apply population PK and PK/PD models to answer defined development questions, using NONMEM and/or Monolix with R for data handling, diagnostics, and simulation.
• Serve as PMx lead on assigned programs: primary author of the analysis plan, author of the modeling report to regulatory submission standard, and accountable owner of the analysis end to end.
• Provide scientific input to project teams on dose, regimen, patient population, and development strategy, including dose justification, exposure-response analyses, and responses to health authority questions.
• Perform quality control and quality review of modeling deliverables, and support scientific oversight of vendor-delivered analyses.
• Identify where modeling can answer a question the team has not thought to ask, and say so.

Partnership and collaboration

• Partner with the PK/PD project leader on the quantitative strategy for your programs, starting from the scientific question and determining the best approach to answer it.
• Build a cross-functional network across statistics, regulatory, medical, ADME, toxicology, and clinical development. Show up wherever modeling input or output is being discussed, and be engaged in those conversations.
• Bring your work to the department forums, including scientific project reviews, and be open about what is still uncertain.
• Elevate the people around you: share what you learn rather than holding it.

Automation, innovation, and AI

• Use and extend the department's automation stack in day-to-day delivery.
• Contribute to shared tooling, templates, and standards so the next analysis starts further along than the last one.

Communication

• Communicate quantitative results clearly and at the level appropriate to the audience, from project teams to senior partners.
• Share work externally over time, through scientific meetings, publications, and regulatory interactions.
• Communicate clearly, concisely, and on time, in writing and in person. Seek feedback actively and give it constructively.

Basic Qualifications

• PhD in pharmacometrics, population pharmacokinetics/pharmacodynamics, computational sciences, engineering, chemistry, statistics or a related modelling area.
• Experience in population PK and/or PK/PD modeling. Thorough understanding of pharmacokinetic and/or pharmacodynamic principles, along with an ability to clearly communicate theories and concepts to specialist and non-specialist audiences.
• Experience using relevant software such as NONMEM (or Monolix), R, and mrgsolve.

Additional Skills & Preferences

• Hands-on experience across the full modeling workflow: dataset specification and creation, exploratory data analysis, covariate evaluation and modeling, model evaluation (VPC, NPDE, goodness-of-fit), simulation, and reporting.
• Experience contributing to a regulatory submission or a health authority response.
• Reproducible analysis practice, including version control (Git) and literate reporting such as Quarto.
• Active engagement with AI and automation in a pharmacometrics context, including hands-on experience with tools, curiosity about what is possible, and the judgment to tell where automation helps and where scientific judgment has to stay human. We are in the middle of a transformation and this person will be part of it.
• Comfort working when the question is not yet fully defined, and a willingness to propose the approach rather than wait to be handed one.
• Adept at working with cross-functional colleagues.
• Excellent self-management and organizational skills, with the ability to prioritize across several programs.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

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 (View email address on click.appcast.io), 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).

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