Senior Director, Modeler

Location: US, Canada, China, Netherland, France, Switzerland, UK

Certara Strategic Consulting is now the largest and most comprehensive model-based drug development and strategic pharmacometrics organization, Certara Strategic Consulting brings together the resources of Certara’s leading consulting group, Pharsight Consulting Services (PCS), with scientific powerhouse, Quantitative Solutions. Deeply committed to our mission of bringing new, safer therapies to patients, we are scientists working with our clients to advance the discipline of modeling and simulation in drug development.

Key Responsibilities:

The Senior Modeler will  be a recognized expert in modeling (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), and an expert in PK/PD and statistical software (e.g. NONMEM, Phoenix WinNonlin, Phoenix NLME, Trial Simulator, Monolix and WinBugs) and programming language(s) (e.g. R, SAS, S-Plus), as well as having know-how and experience in multiple therapeutic areas, such as oncology, cardiovascular, immunotherapy or pediatric products. Experience in addressing comments/questions from with regulatory agencies is desired.  

The Senior Modeler will work closely, and may provide leadership, in teams with other Associates, Modelers and expert drug development consultants supporting projects for Certara’s clients. The Senior Modeler may act as the primary point of contact for clients and collaborate with the manager in business development, lead company initiatives and support recruiting efforts.

Qualifications:

  • PhD, MD, PharmD in Pharmaceutical Sciences, Pharmacology, Toxicology, Statistics, Mathematics, or related fields.
  • 7 to 10 years of industry/consulting experience (may be combined with academic research) working in R&D, pre-clinical and clinical environments.
  • Candidate should have 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, experience in moving compounds through the clinical trial process, experience with various elements of clinical development and trial design, and management and filings.

Skills & Abilities:

  • General knowledge of clinical drug development and demonstrated knowledge of pharmacokinetics and pharmacology is preferred
  • In-depth modeling skills, ability to translate complex problems into incisive models to address them
  • Independent performance of analysis and modeling and development of reports with minimal supervision
  • Good project planning skills. And the ability to independently lead project teams and actively mentor others
  • Strong understanding of business strategy and offerings with ability to contribute to the RFP process and the ability to identify new opportunities through client interactions
  • Comfort in a client environment and able to communicate with and collaborate with scientists and key decision makers
  • Proven ability to lead company initiatives.
  • Excellent writing, editing, and verbal communication skills in English
  • Excellent interpersonal skills

Working at Certara Strategic Consulting

Personal development is not only provided; it is expected. Certara Strategic Consulting is the largest pharmacometric organization in the world and assures that various career pathways are offered to match the ambition and personal interests of their consultants.  Consulting allows for an optimal work-life balance. We prefer working together through office-based locations, but partially working from home is feasible.

Applications:

Email resume to: hr@certara.com

OR

Send to:
Attn: Human Resources

Certara
5520 Dillard Dr., Suite 260
Cary, NC 27518

NO PHONE CALLS OR THIRD-PARTY AGENTS PLEASE.