Director, Pharmacometrics

About Certara

Certara accelerates the potential of bringing medicines to market and to patients using biosimulation software, technology, and services to transform traditional drug discovery and development. Our clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries.

Overview

Our goal is to enable the life sciences industry’s use of data, modeling, and analytics to make better decisions across the various phases of discovery and drug development. Our software and scientists incorporate modern advances in scientific understanding, drug development experience, data analysis, and AI resulting in significant opportunities to decrease the cost and increase the probability of success for new drug approval and commercialization.

Responsibilities

• Deepen strategic drug development expertise and experience informing drug development decisions.
• Hone pharmacometric techniques with fit-for-purpose modeling approaches leveraging e.g. model-based meta-analysis, target‑mediated drug disposition models, and E‑R trial‑simulations.
• Broaden drug development expertise by working with a myriad of companies, molecular modalities, and therapeutic areas.
• Develop a consulting career path by recognizing and seeking opportunities that match ambitions and personal interests.
• Support projects for Certara’s clients by working in teams with other Associates, senior expert modelers, and drug development consultants.
• Hands‑on pharmacometric modeling on client projects as a billable consultant.
• Conduct quality control activities on model codes and reports.
• May lead or coordinate company initiatives (e.g. IT, methodology, efficiency, automation, quality).
• May act as the primary point of contact for clients and collaborate with a senior consultant to grow business to match interests.

Qualifications

• PhD, MD, PharmD in Bioengineering, Pharmaceutical Sciences, Pharmacology, Statistics, Applied Mathematics, Engineering, Medicine, or related field.
• 8–10 years modeling experience.
• Industry consulting experience (may be combined with academic research) working in R&D, pre‑clinical and clinical environments.
• Solid experience in pharmacometrics, clinical pharmacology, pharmacokinetics, or a related discipline in a project team setting.
• Expertise in PK/PD modeling with strong quantitative skills applied to develop models with nonlinear behavior, mechanistic or semi‑mechanistic components relating to mechanism of action and tailored to meet specific drug‑development questions.
• Proficiency in PK/PD and statistical software (e.g. NONMEM, R).
• Proficient in modeling (e.g. popPK and PK/PD analyses, model‑based meta‑analysis, dose‑response and exposure‑response analyses, dataset creation, disease modeling, trial simulation, optimal study designs, strategic decision analyses, economic modeling).
• Experience in moving compounds through the clinical trials process and experience with various elements of clinical development and trial design and management and filings preferred.

EEO Statement

Certara bases all employment‑related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.