Advisor PKPD and Pharmacometrics

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.

For more than a century, Eli Lilly and Company has been committed to making life better. At Lilly, we continuously focus on new and innovative ways to fulfill our extraordinary purpose of making medicines that help people live longer, healthier, more active lives.

Our goal is to add to our diverse team of scientists a teammate passionate about improving the lives of people around the globe. We are looking for creative, hardworking and enthusiastic scientists to join our team. We strive to affect change and deliver results. Do you have the scientific and technical expertise to influence and apply model-informed drug discovery and development? Can you communicate effectively and with confidence? If you answered 'yes' then we are looking for you. Lilly is looking for creative, motivated and enthusiastic scientists to join our Global Pharmacokinetics/Pharmacodynamics and Pharmacometrics Department.

PK/PD and Pharmacometrics scientists are functional leaders in research and development throughout the value chain from preclinical lead molecule identification to clinical post-drug approval. Optimally identifying and developing the right drug with the right dose for the right patient and living the model-informed drug research and development (MIDD) paradigm is the goal.
We need a dynamic and driven scientist who is able to:

• Conduct PK/PD modeling and simulation to inform drug development programs.
• Provide PK/PD/Pharmacometric and scientific leadership to project teams to support the selection of the right target, molecule, dose, patient population, and development strategies.
• Support decision-making through collaboration on cross-functional teams.
• Develop PK/PD sections of program and product team plans as project leader.
• Support the 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 for 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.
• Mentor other scientists within the department and in other areas as well as interact, teach and collaborate with academia.
• Represent the group to increase visibility externally, through key publications, active leadership in key scientific organizations, industry trade groups, or consortia.

In summary, in this exciting scientific role you will have opportunities to be a part of the project team applying model-informed discovery and development approach to innovative medicine. Come join the Lilly family!

Basic Qualifications:

• PhD and/or MD in relevant scientific field such as Pharmaceutical Sciences, biological sciences, bioengineering, etc.

Additional Skills/Preferences:

• While experience from industry, regulatory, consulting or academia with exposure to industry is advantageous, we are also looking for hardworking emerging professionals. Job level will depend on experience
• Knowledge of relevant modeling and simulation software (e.g. NONMEM, Monolix, R, S-Plus, Phoenix NLME, MATLAB, Berkeley Madonna etc.)
• Experience in pharmacokinetics, pharmacometrics, clinical pharmacology, population PK modeling, exposure-response modeling, clinical trial simulation
• Communicate effectively and with confidence

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( [email protected] ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

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Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.

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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