Description

Director Model-Based Meta-Analysis

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.

We are the largest pharmacometric organization in the world, which enables us to assure that various career pathways are offered which match the ambition and personal interests of our employees!  As one of Certara’s divisions, we deliver value by applying model informed drug development (MIDD) concepts and solutions into the most crucial drug development deliverables - to inform internal decision-making and strengthen global regulatory submissions.   Leveraging our experience in working on thousands of 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. 

The Director Pharmacometrics supports client early and late clinical development engagements by providing pharmacometric evaluations that address 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. For this specific role, we are looking for candidates with demonstrated MBMA experience, to conduct exploratory as well as more formal MBMA analyses across a wide range of therapeutic areas, support clients in the interpretation of MBMA results and how those may impact decision making within their development programs.   

• Conduct MBMA analyses to address client’s key drug development questions
• Work as a billable consultant (~80% of “time in the office”) on client projects. Consulting is typically done via hands-on modelling and simulation work.
• Work closely with our Data Science team to optimize clinical outcomes databases to meet client needs and enable optimally informative MBMA evaluations. 
• Participate in company initiatives (e.g. advancements to methodology, efficiency, automation, IT, quality).
• Conduct quality control and quality assurance activities on model codes and reports.
• May supervise project contributions of associate scientists or other colleagues.

• Proficient in modelling, specifically MBMA, but additionally in one or more other MIDD capabilities (e.g., popPK and PK/PD analyses, dose-response and exposure-response analyses, dataset creation, database augmentation, disease modeling, trial simulation, optimal study designs, strategic decision analyses, economic modeling).
• Proficient in relevant pharmacometrics software (primarily R and NONMEM).
• General knowledge of clinical drug development and demonstrated knowledge of pharmacokinetics and pharmacology is preferred.
• General modeling skills, ability to translate complex data into fit-for purpose models to address key drug development questions.

https://uscareers-certara.icims.com/jobs/1205/director%2c-model-based-meta-analysis/job