Director, Pharmacometrician
14 ore fa
Overview:
**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
Certara is a global team that fosters and nurtures a diverse and inclusive culture. We are proud to be an Equal Opportunity Employer. The collective sum of our individual differences, life experiences, knowledge, innovation, self-expression, and unique capabilities and talent represents a significant part of our culture, our reputation and our achievement.
**Together with our partners, we use biosimulation and technology-enabled **services to transform drug discovery and development across all therapeutic **areas and innovative therapies**.**
**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.
- 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.
- Independent performance of analysis and modeling and development of reports with limited supervision.
- Comfortable in a client environment able to communicate with and collaborate with peer scientists.
- Developing ability to identify new business development opportunities through client interactions.
- Proficient in spoken and written English. Certara is a global company, and additional languages are of benefit.