Associate Director, Clinical Pharmacology
About The Position
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 Research & 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. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in New Jersey office (Jersey City) to ensure effective management, operational excellence, and delivery of clinical studies and to support the expected significant team growth & collaboration. 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.
Requirements
- Postgraduate degree in pharmacometrics, pharmacokinetics, pharmacology, pharmaceutical science, mathematics/statistics, engineering, or related field. PhD with minimum 3 years, or PharmD with minimum 5 years, or MS with 8+ 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.).
- 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.
- 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.
Responsibilities
- 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.
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Ph.D. or professional degree
