Associate Director, Pharmacometrics

5 giorni fa

Provincia di Firenze Toscana, Italia Certara A tempo pieno

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.

At Certara, we accelerate medicines to patients by partnering with life science innovators.
- Informed decision-making & reduced clinical trial burden
- Higher R&D productivity
- Improved patient outcomes & increased patient access to medicines
- Accelerated regulatory approval

**Responsibilities**:
We are looking for Pharmacometricians that want to:

- Deepen their strategic drug development expertise and their experience informing drug development decisions.
- Hone their pharmacometric techniques with fit-for-purpose modelling approaches leveraging e.g. model-based meta-analysis, target-mediated drug disposition models, and E-R trial-simulations.
- 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.
- 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/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 their interests

Qualifications:

- PhD, MD, PharmD in Bioengineering, Pharmaceutical Sciences, Pharmacology, Statistics, Applied Mathematics, Engineering, Medicine, or related field.
- 1 to 5 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 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 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._

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