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Sr. Advisor - Pk/Pd & Pharmacometrics

3+ years
Not Disclosed
Not Disclosed March 25, 2025
Job Description
Job Type: Full Time Education: PhD/MD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Sr. Advisor - PK/PD & Pharmacometrics
Location: Indianapolis, Indiana, United States of America
Category: Research & Development
Job Type: Full-Time, Regular
Job ID: R-79304

Company Overview:
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, with a mission to discover and bring life-changing medicines to those who need them. Our employees are dedicated to improving disease management and contributing to communities through philanthropy and volunteerism.

Compensation:
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is:

  • $142,500 - $228,800

About the Role:
We are the Global Pharmacokinetics/Pharmacodynamics and Pharmacometrics Department at Lilly, seeking top talent to join our team. Our PK/PD & Pharmacometrics scientists are the functional leaders from drug discovery to clinical development, approval, and life-cycle management. Our goal is to identify the right dose of the right drug for the right patient while embracing the model-informed drug discovery and development (MIDD) paradigm.

Responsibilities:

  • Provide PK/PD scientific leadership to project teams, ensuring the selection of the right dose, patient population, and development strategies.

  • Understand challenges in drug development and drive effective decision-making and solutions.

  • Lead PK/PD aspects of project team plans and integrate quantitative approaches into drug development.

  • Develop and support the preparation of Phase I, II, and III study protocols, analysis plans, data analysis and interpretation, and study reports.

  • Prepare regulatory documents (INDs, IBs, CTDs, etc.) for drug development and registration across geographies.

  • Apply PK/PD and pharmacometric approaches to translate from preclinical to clinical settings by integrating relevant inputs.

  • Communicate quantitative data and advocate for model-based decision-making within project teams and external partners.

  • Mentor and coach scientists within the department and collaborate with academia.

  • Represent the group to increase external visibility through key publications and active leadership in scientific organizations, industry groups, or consortia.

Basic Qualifications:

  • PhD and/or MD in Pharmacokinetics/Pharmacodynamics, Clinical Pharmacology, Pharmacometrics, Computational Sciences, Engineering, Statistics, or a related field.

  • At least 3 years of relevant work experience in PK/PD and/or Clinical Pharmacology.

Additional Skills/Preferences:

  • Strong understanding and experience in applying pharmacokinetics, pharmacodynamics, pharmacometrics, and clinical pharmacology principles in drug development.

  • Effective and confident communication skills.

Diversity & Inclusion:
Lilly is an EEO/Affirmative Action Employer that does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.

Accommodation for Individuals with Disabilities:
If you require accommodation to submit a resume for this position, please complete the
accommodation request form.

Employee Resource Groups (ERGs):
Lilly’s ERGs offer strong support networks and help develop talented individuals for future leadership roles. Our ERGs include the African American Network, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, and more.

Benefits:
Full-time equivalent employees are eligible for a company bonus, and Lilly offers a comprehensive benefits program, including:

  • Company-sponsored 401(k) and pension plans

  • Medical, dental, vision, and prescription drug benefits

  • Life insurance and death benefits

  • Flexible spending accounts for healthcare and dependent care

  • Well-being programs (e.g., employee assistance programs, fitness benefits)

Lilly reserves the right to amend, modify, or terminate its compensation and benefits programs at its discretion.

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