Eli Lilly

Advisor/Senior Advisor - Clinical PK/PD Project Leader

Eli Lilly$153K — $246K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

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 Quantitative Clinical Pharmacology, Clinical PK/PD, Clinical PBPK modeling, and/or Pharmacometrics.
  • Thorough understanding of pharmacokinetics, pharmacodynamics, and clinical pharmacology principles.
  • Track record of applying model-informed drug development (MIDD) approaches.
  • Hands-on experience with non-linear mixed-effect (NONMEM, Monolix, R) and/or PBPK modeling software (SimCYP, GastroPlus, PK-Sim, MATLAB, R).

Responsibilities

  • Provide scientific leadership in PK/PD and quantitative clinical pharmacology for project teams.
  • Partner with modelers to deliver quantitative insights that influence portfolio decisions.
  • Conduct exploratory PK/PD analyses during early development.
  • Identify and address challenges in the drug development process with data-driven solutions.
  • Lead PK/PD aspects of program plans and integrate quantitative methods into drug development.
  • Prepare and deliver study protocols, analysis plans, and reports for clinical trials.
  • Draft regulatory documents for drug development and interact with regulatory agencies.

Benefits

  • Comprehensive medical, dental, vision, and prescription drug benefits.
  • 401(k) and pension plan participation.
  • Vacation and leave benefits.
  • Well-being programs, including fitness benefits and employee assistance programs.
Full Job Description
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.


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.

#WeAreLilly

About Eli Lilly

ICOS Corporation is a biotechnology company that engages in the discovery, development, and commercialization of therapeutic products. It is engaged in the commercialization of treatments for unmet medical conditions, such as benign prostatic hyperplasia, hypertension, pulmonary arterial hypertension, cancer, and inflammatory diseases. It is the developer of a treatment known as Cialis (tadalafil), a product for the treatment of erectile dysfunction through its joint venture with Eli Lilly and Company in North America and Europe. It is also engaged in contract manufacturing services for third parties. It is in a strategic alliance with Solvay Pharmaceuticals, Inc. ICOS Corporation was established in 1989, based in Bothell, Washington. It is currently operated by Eli Lilly and Company.

Eli Lilly Careers

Joining Eli Lilly offers an unparalleled opportunity to become part of a leading global team dedicated to creating a healthier future. As a company revered for its commitment to innovation and leadership in the pharmaceutical industry, Eli Lilly is where your professional journey can flourish. Work You’ll Do At Eli Lilly, we are passionate about transforming patient care and advancing medical innovation. Our team at Eli Lilly is at the forefront of developing groundbreaking solutions in healthcare. By joining us, you will collaborate with some of the brightest minds in the industry, using cutting-edge technology to make real-world impacts. Lead with Innovation and Leadership Eli Lilly stands out in the marketplace by integrating deep industry expertise with robust research and development efforts. We are looking for professionals who are eager to drive change and lead the way in developing therapeutic breakthroughs. Explore Job Opportunities and Growth Eli Lilly offers a variety of career paths, including full-time positions and internships, across multiple functions such as research, marketing, IT, and sales. Whether you are a seasoned professional or a recent graduate, Eli Lilly provides an environment that promotes career growth and learning opportunities. Our commitment to diversity and leadership training ensures that every employee can achieve their potential. Be Part of Our Team Our team at Eli Lilly is committed to excellence and driven by a mission to improve lives. Employees enjoy a supportive culture that values collaboration, creativity, and diversity. We believe that a diverse workforce fosters innovation and helps us better connect with the communities we serve. Benefits and Culture Eli Lilly is dedicated to supporting our employees, offering competitive benefits, wellness programs, and comprehensive health care. Our culture is built on a foundation of respect, integrity, and quality, making Eli Lilly not just a great place to work, but a community to grow with. Networking and Professional Development Eli Lilly encourages continuous professional development and networking. With access to various training programs and mentorship opportunities, employees can enhance their skills and advance their careers. Our leadership is committed to nurturing talent through effective training and development strategies. Join Our Team Discover the exciting job opportunities at Eli Lilly by exploring open positions that match your skills and interests. We are continuously hiring and looking for individuals who are passionate, innovative, and ready to contribute to our mission of making life better for people around the globe. Stay Connected Keep up to date with the latest at Eli Lilly by following our careers blog. Gain insights from industry leaders and get tips on everything from crafting the perfect resume to preparing for your interview. Eli Lilly is not just a company—it's a place where you can make a difference. Explore the positions available and find out how your talents can help change the world. SEARCH ELI LILLY JOBS Stay ahead in your career with Eli Lilly, where innovation, leadership, and a commitment to diversity and growth lead the way to future advancements.
Learn more about Eli Lilly
Size
35,000 employees
Market Cap
$344.2 billion
Industry
Net Income
$6.1 billion
Founded
1876
5 Year Trend
+5.9%
Revenue
$24.5 billion
NASDAQ

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