Certara is a growing company that provides a dynamic and exciting place to work. Our purpose is to assist in accelerating the development of meaningful medicines that make an impact on our society and the people that need them most. Innovation and creativity are highly valued, and everyone is given the opportunity for training and continuous development. Our portfolio spans the discovery, preclinical, clinical and post-marketing phases of drug development, working with 1,200 commercial companies, 250 academic institutions, and numerous regulatory agencies.
Support team member and project leaders with parts of the design, execution, and management of clinical pharmacology studies, from early translation to late development. **
- Works collaboratively with Certara team members to ensure an adequate clinical pharmacology package and study design to enable IND/First in human to NDA/BLA
- Collaborates and supports internal team members on the delivery of parts of regulatory, clinical pharmacology, pharmacometric specific activities to support drug development
- Supports team in writing of pharmacokinetic (PK) analysis plans and PK sections in Clinical Study Report
- Performs study related tasks such as non-compartmental analyses (NCA) and creates PK tables, figures and listings (TFL)
- Conducts quality control and quality assurance activities on datasets, data analysis, and reports
- Support certain clinical operational aspects of a clinical pharmacology study (data specification and transfers, review protocol deviations, review CRFs)
- Knowledge of in vitro DMPK data impacts on clinical pharmacology study design
- Assists team members in summarizing clinical pharmacology and building table(s) with information across clinical pharmacology studies
- Reviews and summarizes information in study reports for inclusion in regulatory documents
- Co/authoring peer-reviewed manuscripts and publications
- Reviews publications to keep apprised to keep apprised of new clinical pharmacology and therapeutic area developments
- Involvement in program committees, workshops, and other professional organization meetings/se ssions
- PhD, PharmD, MD or associated degree with specialization in pharmacology or pharmacokinetics, or in a related scientific discipline,
or Bachelors or Master’s degree with equivalent experience. - Minimum of 2 years of experience in Post-Doctoral work (Fellowship, residencies) or experience in Pharmaceutical Industry or related industry.
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.