Senior Director, Pharmacometrics

Certara is a growing company that provides a dynamic and exciting place to work. Our purpose is to assist in accelerating the development of meaningful medicines that make an impact on our society and the people that need them most. Innovation and creativity are highly valued, and everyone is given the opportunity for training and continuous development. Our portfolio spans the discovery, preclinical, clinical and post-marketing phases of drug development, working with 1,200 commercial companies, 250 academic institutions, and numerous regulatory agencies.

In the past 6 years, over 90% of companies that received new drug approvals by the FDA used our software or services. Our integrated and proprietary end-to-end platform with biosimulation, regulatory science, and market access solutions combined with our strong team of scientists and subject matter experts enable our clients to have:

• Informed decision-making & reduced clinical trial burden
• Higher R&D productivity
• Improved patient outcomes & increased patient access to medicines
• Accelerated regulatory approval

Responsibilities

• Support quantitative decision-making in drug development through the development and application of population PK, PK / PD, exposure-response and other models.
• Work on a variety of therapeutic indications and data types as an expert in applied Population PK, PK / PD, and / or exposure-response modelling and simulation.
• Deepen strategic drug development expertise and experience informing drug development decisions.
• Hone pharmacometric techniques with fit-for-purpose modelling approaches leveraging model-based meta-analysis, target-mediated drug disposition models, and E-R trial-simulations.
• Broaden drug development expertise by working with various companies, molecular modalities, and therapeutic areas.
• Develop consulting career path by recognizing and seeking opportunities that match ambition and personal interests.
• Support projects for Certara’s clients by working in teams with other Associates, senior expert modelers, and drug development consultants.
• Conduct hands-on pharmacometric modeling on client projects as a billable consultant.
• Perform quality control activities on model codes and reports.
• Lead / coordinate company initiatives (e.g. IT, methodology, efficiency, automation, quality).
• 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.
• 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 is preferred, whether in academia or industry.
• Expertise in PK / PD modelling 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.

Certara bases all employment-related decisions 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.

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