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Director, Clinical Pharmacology

Employer
Eikon Therapeutics
Location
Jersey City, New Jersey
Start date
Nov 11, 2023

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Job Details

Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.

Position

We are seeking an enthusiastic Director, Clinical Pharmacology to join our growing Clinical Development organization and build Modeling and Simulation in the Clinical Pharmacology group. The modeling and simulation activities include NCA, population PK/PD, disease progression, statistical and physiologically-based PK (PBPK) modeling, allometric scaling, quantitative system pharmacology (QSP), clinical trial simulations, literature meta-analysis, machine learning/deep learning, and other state-of-the-art quantitative techniques. The candidate will support Clinical Pharmacology Project Leads for the use of quantitative approaches to describe the relationship between drug exposure and response, and to select and defend first in human dose, RP2D, and labeled dose during regulatory interactions.

About You

You have a passion for innovation, independence, an entrepreneurial spirit, and a strong desire to learn and grow with the best professionals in the industry.

What You’ll Do

  • Support Clinical Pharmacology Project Leads in analyzing data from preclinical, clinical and stand-alone Clinical Pharmacology studies.
  • Utilize basic and advanced modeling and simulation techniques to undertake comprehensive Exposure-Response analysis.
  • Generate and interpret pharmacokinetic/pharmacodynamic (PK/PD) models to inform dose selection and regimen optimization.
  • Undertake diverse scaling approaches to design optimal dosing regimens for First-In-Human and special populations (e.g. pediatrics)
  • Conduct biopharmaceutics data analyses (e.g. dissolution performance) with the objective of translating in vitro formulation performance to in vivo formulation performance in humans.
  • Organize, execute, and report M&S independently, as well as present findings in a clear and concise manner to support decision-making.
  • Plan, write, and review pharmacometrics aspects in relevant clinical documents such as study protocols, analysis plans, clinical study reports, and regulatory documents.
  • While performing core tasks, get trained on diverse Clinical Pharmacology study types and drug development by experienced Project Leads to eventually take on Lead role.

Qualifications

  • Degree in pharmacometrics, pharmacokinetics, pharmacology, pharmaceutical science, mathematics/statistics, engineering, or related field. PhD with minimum 5 years, or PharmD with minimum 8 years, or MS with 10+ years of experience in a pharmaceutical industry or academic setting.
  • Hands-on experience with PKPD modeling software (NONMEM, R, SAS, MATLAB, Phoenix, SimCyp, GastroPlus, etc.) is a must.
  • Knowledgeable in quantitative pharmacology and strong hands-on modeling and simulation experience with PK/PD analysis to inform dose selection, safety profile characterization, and product labeling.
  • Demonstrated ability to independently plan, organize, and analyze PK/PD data is essential.
  • Highly motivated individual with a strong intellectual and technical background who can thrive in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.
  • Excellent problem-solving, written and oral communication skills.

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:

  • 401k plan with company matching
  • Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
  • Mental health and wellness benefits
  • Weeklong summer and winter holiday shutdowns
  • Generous paid time off and holiday policies
  • Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
  • Enhanced parental leave benefit
  • Daily subsidized lunch program when on-site

The expected salary range for this role is $204,000.00 to $235,000.00 depending on skills, competency and the market demand for your expertise.

Company

Eikon is a pioneering drug discovery and development company that leverages superior engineering and high-performance computing to analyze single molecule protein behavior in living cells. We are engineering a battery of innovative tools and technologies for biological exploration in drug discovery and beyond.

Eikon thrives on the energy and creativity of interdisciplinary teams. We are physicists and chemists, biologists and engineers. We spend our days context-switching between multiple scientific languages. We work with lasers, super-resolution microscopes, and robot arms. We leverage machine learning, cell line engineering, and the collective intelligence of world-class scientists and technologists to observe therapeutically relevant biology in a way no one has before.

We’re endlessly curious, intellectually honest and we love what we do. We’re driven to learn the true mechanisms of biology and pharmacology at the molecular level, to make the biggest difference in as many lives as possible.

Company info
Website
Location
3929 Point Eden Way
Hayward
CA
94545
United States

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