Director Clinical Pharmacology

Position We are seeking an enthusiastic Director of 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 Post Graduate degree with 10+ years of experience or a Bachelors degree with 12+ years of experience in Pharmacology, Pharmaceutical Sciences, or a 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. The expected salary range for this role is $213,000 to $232,750 depending on skills, competency, and the market demand for your expertise.

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