Associate Director, Clinical Pharmacology

1 month ago

Jersey City, United States Eikon Therapeutics Full time

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 Associate 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 a Project Representative role.

Qualifications

Typically requires a minimum of 10+ years of experience with a Bachelor's degree, or 8+ years of experience with a post graduate degree.  Degree in pharmacometrics, pharmacokinetics, pharmacology, pharmaceutical science, mathematics/statistics, engineering, or related field. 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 $170,000 to $185,250 depending on skills, competency, and the market demand for your expertise.

Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.

In accordance with the Company’s duty to provide and maintain a safe workplace, the Company requires all employees to be Fully Vaccinated with one of the FDA approved COVID-19 vaccines, which includes those vaccines that have received the FDA’s emergency use authorization. You will be expected to be Fully Vaccinated as of your Start Date. If you believe that you are exempt from this requirement under an applicable law or regulations, including Americans with Disabilities Act and California’s Fair Employment and Housing Act, you will need to contact the Company’s Human Resources group. For purposes of this section, Fully Vaccinated means (i) the completion of the vaccination regimen as approved by the FDA (by way of example, 2 doses of the Pfizer or Moderna vaccine and 1 dose of the Johnson and Johnson vaccine), and (ii) timely receiving booster vaccination, as recommended by the Centers for Disease Control and Prevention.

We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.

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