Director – Executive Director, PK/PD & Pharmacometrics (Level based on experience)

BioSpace; Indianapolis (IN); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Lilly, headquartered in Indianapolis, Indiana, seeks a Director – Executive Director for PK/PD & Pharmacometrics to lead quantitative pharmacology across Drug Discovery and Development. The role emphasizes model-informed drug discovery, cross-functional collaboration, and regulatory interactions to accelerate medicine development.

You will guide project teams, oversee early- through late-stage PK/PD analyses, and drive data-driven decisions.

Qualifications

• PhD in a relevant discipline and at least 8 years of experience in PK/PD or Clinical Pharmacology
• Experience with pharmacokinetics/pharmacodynamics, pharmacometrics, and clinical pharmacology principles
• Experience with regulatory interactions (FDA/EMA/PMDA) preferred

Responsibilities

• Provide PK/PD and quantitative clinical pharmacology leadership to project teams
• Conduct exploratory MIDD, PK/PD analyses across development stages
• Lead and support study protocols, analysis plans, data analysis and interpretation
• Prepare INDs, IBs, CTDs and regulatory documents for multiple geographies
• Communicate quantitative data clearly and advocate for model-based decision making
• Coach and mentor scientists within the department
• Represent the group in publications and scientific organizations

Skills

Cross-functional collaboration

Communication of quantitative concepts

Regulatory interactions

Leadership and mentoring

Scientific leadership

Education

PhD in a relevant discipline

Tools

PK/PD modeling

Regulatory documentation

Job description

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.

Director – Executive Director, PK/PD & Pharmacometrics

(Level based on experience)

Location

• Bracknell, UK or
• Indianapolis, US

Hybrid (3/2) working

Reports to

Executive Director - Global PK/PD & Pharmacometrics

About Lilly

Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.

Role Overview

The Global PK/PD and Pharmacometrics 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

Main Responsibilities Include

• Provide PK/PD and quantitative clinical pharmacology scientific leadership to project teams to support selection of the right target, molecule, dose, patient population, and development strategy.
• Hands-on conducting exploratory MIDD, PK/PD analysis across development stages.
• Understand and anticipate high-level challenges in the drug development process and drive effective, data-driven decision-making and solutions.
• Lead PK/PD aspects of program and product team plans as project leader; integrate quantitative approaches into drug discovery and/or development.
• Lead and support preparation and delivery of Phase I, II, and III study protocols, analysis plans, data analysis and interpretation, and study reports.
• Prepare relevant INDs, IBs, CTDs, and other regulatory documents supporting development and registration of new drugs and line extensions across multiple geographies; this may involve direct interaction with FDA, EMA, PMDA, and other regulatory agencies.
• Communicate quantitative data clearly and advocate for model-based decision making with cross-functional teams and senior stakeholders.
• Provide coaching and mentoring to other scientists within the department and across disciplines; interact, teach, and collaborate with academia.
• Represent the group to increase external visibility through key publications, and active leadership in scientific organizations, industry trade groups, or consortia.

Basic Requirements

• PhD in a relevant discipline* and at least 8 years of relevant work experience in PK/PD or Clinical Pharmacology
• DMPK, Clinical Pharmacology, Pharmacometrics, Pharmacokinetics/Pharmacodynamics, Pharmaceutics, Biology, Computational Sciences, Engineering, Chemistry, Statistics, Toxicology, or a related discipline.

Additional Skills & Preferences

• Thorough understanding of pharmacokinetics, pharmacodynamics, pharmacometrics, and clinical pharmacology principles.
• Strong track record of cross-functional collaboration and communicating quantitative concepts to non-quantitative audiences.
• Excellent written and verbal communication skills; ability to communicate effectively and with confidence.
• Experience with regulatory interactions (FDA, EMA, PMDA, or other agencies) preferred.

Embracing Diversity

Embracing diversity is at the core of our long-held value of respect for people. It is the lens through which we understand and respond to the unique needs of the millions of individuals who depend on our medicines.

For us, embracing diversity means understanding, respecting, and valuing differences, including but not limited to race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status. The greatest measure of our diversity efforts is our ability to attract and retain exceptional employees who feel comfortable in a culture that supports them being themselves.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

#WeAreLillyUKandIreland