Eli Lilly and Company · 2 weeks ago
Director - PK/PD & Pharmacometrics
Indianapolis, IN
Full-time
Onsite
Director/Executive
$177K/yr - $308K/yr
7+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, focused on discovering and bringing life-changing medicines to those in need. The Director of PK/PD & Pharmacometrics will lead scientific efforts in drug development, ensuring the right dosing and patient strategies while mentoring team members and communicating findings to stakeholders.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Provide PK/PD scientific leadership to project teams to support the selection of the right dose, patient population, and development strategies
Understand the challenges faced during the drug development process and drive effective decision-making and solutions
Lead PK/PD aspects of project team plans and integrate quantitative approaches into drug development
Lead and support the preparation and delivery of Phase I, II, and III study protocols, analysis plans, data analysis and interpretation, and study reports
Prepare relevant regulatory documents (INDs, IBs, CTDs, etc.) for development and registration of new drugs and line extensions across geographies
Apply PK/PD and pharmacometric approaches to translate from preclinical to clinical settings by integrating all relevant inputs
Communicate quantitative data and advocate for model-based decision-making within project teams and to external stakeholders
Provide coaching and mentoring to other scientists within the department and beyond; 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
Qualification
Required
Ph.D. in Pharmaceutical Sciences, Pharmacy, Pharmacokinetics, Clinical Pharmacology, Pharmacometrics, Engineering, Statistics, or a related discipline
At least 7 years of relevant drug development and regulatory experience within the field of PK/PD, Pharmacometrics, Clinical Pharmacology, Translational Medicine, or a closely related field
Preferred
Thorough understanding and experience applying pharmacokinetics, pharmacodynamics, pharmacometrics, and clinical pharmacology principles within drug development teams
Track record of applying model-informed drug development (MIDD) approaches to inform drug development and/or regulatory decision-making
Hands-on experience applying non-linear mixed effect software and principles such as NONMEM, Monolix, and R, and/or physiologically-based pharmacokinetic (PBPK) modeling software and principles such as SimCYP, GastroPlus, PK-Sim, MATLAB, and R
Excellent communication, collaboration, and leadership skills and the ability to influence cross-functional teams
Strong track record of scientific contributions to the field of pharmacokinetics, pharmacodynamics, clinical pharmacology, and/or pharmaceutical sciences
Benefits
Company bonus
401(k)
Pension
Vacation benefits
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
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
10001+ employees
H1B Sponsorship
Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (514)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
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