Director, Pharmacometrics

Overview:
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.

Quantitative Science Services is the largest pharmacometric organization in the world, which enables us to offer various career pathways that match the ambition and personal interests of our employees We are a core component of Certara and deliver value by integrating advanced modeling and simulation approaches into the most crucial drug development deliverables—to inform internal decision-making and strengthen global regulatory submissions. Leveraging our collective 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.

In this role, you will play a pivotal part in supporting and leading client early and late clinical development engagements by providing scientific and strategic pharmacometrics input that addresses key questions in their development programs, clinical study design considerations, model-informed drug development strategies, as well as interactions with and submissions to regulatory authorities. Additionally, you will have the opportunity to mentor colleagues and drive company initiatives that keep Certara at the forefront of innovation in model-informed drug development.

**Responsibilities**:
Our Pharmacometricians are responsible for providing expertise in clinical development plans, including designing, conducting, and interpreting relevant clinical pharmacology and PKPD studies.

We are looking for Pharmacometricians who want to:

- Deepen their strategic drug development expertise and experience in informing drug development decisions.
- Hone their pharmacometric techniques with fit-for-purpose modeling approaches, leveraging e.g., model-based meta-analysis, target-mediated drug disposition models, and clinical trial simulations.
- Serve as a consultant on client projects by providing a combination of hands-on modeling and project scoping, analysis plan development, results interpretation, reporting, and sharing with client teams.
- 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.
- Provide project leadership to multiple consultants, supervise project contributions of more junior colleagues, and/or act as account leader.
- Support our Business Development teams through the maintenance of client relationships and the writing of proposals.
- Lead company initiatives (e.g., IT, methodology, efficiency, automation, quality), conduct quality control and quality assurance activities on model codes and reports, and support managers in recruitment and coaching more junior consultants.

Qualifications:

- PhD, MD, PharmD in Pharmaceutical Sciences, Pharmacology, Toxicology, Statistics, Mathematics, or related fields.
- A minimum of 7 to 10 years of industry/consulting experience (may be combined with academic research) working in R&D, pre-clinical, and clinical environments.
- In-depth knowledge of multiple modeling and simulation techniques (e.g., PopPK, PKPD, MBMA, statistical modeling) and multiple TAs.
- Experience in moving compounds through the different phases of development and experience with various elements of clinical development, clinical trial design, and conduct, and regulatory filings.
- Demonstrated skills and experience in pharmacometrics, clinical pharmacology, pharmacokinetics, and pharmacodynamics in a project team setting (including leadership roles), with clients as well as internal staff.
- Deep knowledge and experience in a specific therapeutic area, such as oncology, cardiovascular, immunotherapy, or pediatric products, is of interest.
- Specific expertise with software and methodologies outside of the standard population PK-PD tools is a plus.
- Experience in direct interactions with regulatory agencies is a plus.
- Recognized expertise in modeling and simulation approaches (e.g., popPK and PK/PD analyses, model-based meta-analysis, dose-response and exposure-response analyses, dataset creation, database augmentation, disease modeling, trial simulation, optimal study designs, strategic decision analyses, economic modeling) - supported by a track record of peer reviewed publications
- Expert in PK/PD and statistical software (e.g., NONMEM, Monolix and MatLab) and programming language(s) (e.g., R, SAS, S-Plus).
- General knowledge of clinical drug development and demonstrated knowledge of pharmacokinetics and pharmacology is required.
- In-depth modeling skills, ability to translate complex problems into fit-for-purpose models to addr