Advisor/Senior Advisor – Clinical PK/PD Project Leader

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 153,000 - 246,000; Full time

Benefits offered by this job

Bonus potential

401(k)

Health, dental, vision benefits

Vacation benefits

Well-being programs

Job summary

Lilly is seeking a dynamic Quantitative Clinical Pharmacologist to provide PK/PD leadership on project teams and drive model-based decision-making across our portfolio. You will collaborate with PBPK, QSP, and Pharmacometrics modelers to deliver quantitative insights that shape development strategies across multiple geographies.

The role involves leading study protocols, analysis plans, and regulatory filings (INDs/CTDs), with opportunities to mentor colleagues and contribute to publications.

Qualifications

• PhD in Pharmaceutical Sciences or related field with drug development/regulatory exposure.
• 2+ years of relevant experience in Quantitative Clinical Pharmacology, PK/PD, or Pharmacometrics.

Responsibilities

• Provide PK/PD leadership to project teams to support dose and development strategy.
• Collaborate with PBPK, QSP, and PM modelers to inform portfolio decisions.
• Conduct exploratory PK/PD analyses in early development stages.
• Drive data-driven decision-making and solutions for drug development challenges.
• Lead PK/PD aspects of study plans and analysis reports across phases I–III.
• Prepare regulatory documents (INDs, IBs, CTDs) and interact with agencies as needed.

Skills

PK/PD leadership

Quantitative pharmacology

MIDD approaches

PBPK/QSP/PM modeling

NONMEM/Monolix/R

Education

PhD in Pharmaceutical Sciences or related

2+ years in drug development/regulatory

Tools

NONMEM

Monolix

R

SimCYP

GastroPlus

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Role Overview

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.

Role Overview

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

Main Responsibilities

• Provide PK/PD and quantitative clinical pharmacology scientific leadership to project teams to support selection of the right dose, patient population, and development strategy.
• Partner with PBPK, QSP and Pharmacometrics modelers to bring the best quantitative answers and influence portfolio decisions
• Conduct exploratory PK/PD analysis in early 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 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.
• May coach and mentor other scientists within the department and beyond; interact, teach, and collaborate with academia.
• May represent the group to increase external visibility through key publications and active leadership in scientific organizations, industry trade groups, or consortia.

Basic Qualifications

• PhD in Pharmaceutical Sciences, Pharmacy, DMPK, Pharmacokinetics, Clinical Pharmacology, Pharmacometrics, Engineering, Statistics, or a related discipline.
• Minimum of 2 years of relevant drug development and regulatory experience in areas such as Quantitative Clinical Pharmacology, Clinical PK/PD, Clinical PBPK modeling, and/or Pharmacometrics.

Additional Skills/Preferences

• 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 development and/or regulatory decision-making.
• Hands-on experience with non-linear mixed-effect software and principles (NONMEM, Monolix, R) and/or PBPK modeling software (SimCYP, GastroPlus, PK-Sim, MATLAB, R).
• Excellent communication and collaboration skills; ability to influence cross-functional teams.
• Strong track record of scientific contributions to the field of pharmacokinetics, pharmacodynamics, or clinical pharmacology.

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 (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).

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

$153,000 - $246,400

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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