PKPD Project Leader – Innovation Solutions

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Since 2014, Lilly has launched 18 new molecular entities globally, with several high value launches yet to come.  Looking ahead, we have a new challenge: to sustain this productivity and drive additional growth.  To push to this next level, Lilly is building a new model that allows us to participate in and advance external biotechnology innovation. We see an opportunity for Lilly to provide value-added R&D solutions including discovery and development capabilities and consultation to drive external innovation.  Ultimately, we envision a R&D solutions business that engages with hundreds of companies around the world, providing a superior partnering experience vs. CROs, and creating a shared interest in their success.

In support of this new model, the ADME/Toxicology/PKPD (ATP) organization is seeking an experienced drug discovery and development pharmacokinetic/pharmacodynamic (PKPD) scientist interested in leveraging their expertise to bring the needed capabilities to each new external partnership.  You will work with a team of like-minded scientists to provide expertise in areas including toxicology, pathology, drug metabolism, pharmacokinetics/bioanalytical, translational/predictive drug disposition, PKPD, and immunogenicity across multiple modalities to advance various external innovation initiatives.  You will engage in consultation, experimental design, execution and/or data interpretation to help deliver a diverse external portfolio of investigational targets and novel therapeutics.

If you are interested in applying your expertise to advance the science of drug discovery and development working in a highly collaborative, innovative setting, we hope you’ll consider joining us.

Responsibilities:

• Engage in ATP-focused discussions as an advisor/consultant with external start-up and biotechnology companies to develop testing strategy to achieve drug discovery and development milestones
• Provide PKPD expertise to shape study designs, guide human dose selection, aid issue resolution, and interpret data.
• Leverage ATP experts to navigate internal vs. external work plans
• Prepare nonclinical data packages to support global regulatory submissions and correspondence; engage with global regulators
• Partner with R&D Solutions ATP leader to forecast capability demand, strategy for internal vs. external work execution, and build a suite of ATP capabilities to offer external companies.

Basic Qualifications:

• Ph.D. degree in Pharmaceutical Sciences, Quantitative Pharmacology, Pharmacometrics, or an advanced degree in a related science with extensive relevant training
• Minimum 10 years of experience in the pharmaceutical industry including significant experience in drug discovery and development in one of the above scientific disciplines
• Experience in drug discovery and development across multiple modalities and therapeutic areas
• Ability to handle multiple simultaneous projects and manage competing priorities

Skills/Preferences:

• Thorough understanding of pharmacokinetics and pharmacodynamic principles along with an ability to clearly communicate theories and concepts.
• Strong understanding of global regulatory guidances that shape the PKPD program strategy
• Experience leading drug discovery and development programs as the PKPD expert through significant milestones (candidate identification, first-in-man studies, proof-of-concept).
• Collaborative team behaviors and desire to build and sustain relationships with R&D colleagues, external partners, and the wider scientific community
• Strong passion for pharmaceutical innovation
• Adept at working with cross-functional colleagues
• Excellent self-management and organizational skills
• Demonstrated strong collaboration and communication skills
• Familiarity with business development, such as search and evaluate, due diligence, or transactions, or experience with external partners, including start-up and biotechnology companies.

Additional Information:

• Some travel required for conferences and external company meetings

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As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law). 

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