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

Director Executive Director, PK/PD & Pharmacometrics

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.

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.

We are seeking a dynamic, curious, and collaborative scientist ready to provide PK/PD scientific leadership on project teams and drive impactful, model-based decision making across our portfolio.

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 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 for further assistance. 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.