Eli Lilly

Director - Executive Director, PK/PD & Pharmacometrics (Level based on experience)

Eli Lilly$160K — $190K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • PhD in a relevant discipline (DMPK, Clinical Pharmacology, Pharmacometrics, or related fields).
  • At least 8 years of experience in PK/PD or Clinical Pharmacology.
  • Deep understanding of pharmacokinetics, pharmacodynamics, and pharmacometrics principles.
  • Proven track record of cross-functional collaboration.
  • Excellent written and verbal communication skills.

Responsibilities

  • Provide scientific leadership on PK/PD and quantitative clinical pharmacology for project teams.
  • Conduct hands-on exploratory modeling and PK/PD analysis throughout development stages.
  • Anticipate challenges in drug development and drive data-driven decisions.
  • Integrate quantitative approaches into drug discovery as project lead.
  • Prepare study protocols, analysis plans, and lead data interpretation for Phase I, II, and III studies.
  • Prepare regulatory documents (INDs, IBs, CTDs) and interact with regulatory agencies.
  • Communicate complex quantitative data to diverse stakeholders and advocate for model-based decision-making.
  • Coach and mentor junior scientists and collaborate with academic institutions.

Benefits

  • Hybrid working model (3 days in office, 2 days remote).
  • Opportunity for impactful leadership in an innovative pharmaceutical environment.
  • Engagement with regulatory agencies and prominent scientific organizations.
  • Access to professional development and mentoring opportunities.
Full Job Description
Job title: Director - Executive Director, PK/PD & Pharmacometrics
(Level based on experience)


Location:
  • Bracknell, UK or
  • Indianapolis, US


Hybrid (3/2) working

Reports to: Executive Director - Global PK/PD & Pharmacometrics

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

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

MAIN RESPONSIBILITIES INCLUDE:
  • Provide PK/PD and quantitative clinical pharmacology scientific leadership to project teams to support selection of the right target, molecule, dose, patient population, and development strategy.
  • Hands-on conducting exploratory MIDD, PK/PD analysis across 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 discovery and/or 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.
  • Provide coaching and mentoring to other scientists within the department and across disciplines; interact, teach, and collaborate with academia.
  • Represent the group to increase external visibility through key publications, and active leadership in scientific organizations, industry trade groups, or consortia.


BASIC REQUIREMENTS:
  • PhD in a relevant discipline* and at least 8 years of relevant work experience in PK/PD or Clinical Pharmacology


*DMPK, Clinical Pharmacology, Pharmacometrics, Pharmacokinetics/Pharmacodynamics, Pharmaceutics, Biology, Computational Sciences, Engineering, Chemistry, Statistics, Toxicology, or a related discipline.

ADDITIONAL SKILLS & PREFERENCES:
  • Thorough understanding of pharmacokinetics, pharmacodynamics, pharmacometrics, and clinical pharmacology principles.
  • Strong track record of cross-functional collaboration and communicating quantitative concepts to non-quantitative audiences.
  • Excellent written and verbal communication skills; ability to communicate effectively and with confidence.
  • Experience with regulatory interactions (FDA, EMA, PMDA, or other agencies) preferred.

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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