Scientist, Pharmacometrics

Overview: About Certara Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions and regulatory agencies across 62 countries. Certara Strategic Consulting is the largest pharmacometric consultancy organization in the world and assures that various career pathways are offered to match the ambition and personal interests of our employees! We are a division of Certara and deliver value by integrating advanced simulation approaches into the most crucial drug development deliverables—to inform internal decision-making and strengthen global regulatory submissions. Leveraging our experience working on thousands of key drug development projects on behalf of hundreds of biopharma companies, we bring a track record of success and a broad range of expertise to each assignment.
Our Pharmacometricians are responsible for providing expertise into clinical development plans, including the design, conduct, and interpretation of relevant clinical pharmacology and PK/PD studies. Qualified candidates will have the ability to work on a variety of therapeutic indications and data types with an adequate understanding of applied population PK and PK/PD modeling and simulation to support drug development programs. We are looking for Pharmacometricians that want to:

• 
  Deepen their strategic drug development expertise and their experience informing drug development decisions.
• Perfect their pharmacometric techniques with fit-for-purpose modeling approaches such as population PK and PK/PD modeling, target-mediated drug
  disposition TMDD) models, dose- and exposure-response analyses.
• Broaden their drug development expertise by working with a myriad of companies, molecular modalities, and therapeutic areas.
• Develop their consulting career path by recognizing and seeking opportunities that match their ambition and personal interests.

Responsibilities:

• 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.
• Continuing education on advanced modeling and simulation approaches, with an emphasis on methods appropriate for small molecules and/or complex biologics, (bispecific biologics, chimeric antigen receptor T-cell therapies, and immunooncology therapies).
• Conduct quality control activities on model codes and reports.

Qualifications:

• MSc, PhD, PharmD, or equivalent in Pharmaceutical Sciences, Pharmacology, Toxicology, Statistics, Mathematics, or related fields. A minimum of 1 to 3 years of 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 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 software used for modeling analyses (e.g. Phoenix NLME, NONMEM, Adapt, Monolix) and performs dataset construction (e.g. R, SAS).
• Independent performance of analysis and modeling and development of reports with limited supervision.
• Proficient in spoken and written English. Certara is a global company, and additional languages are of benefit.

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.