Scientist, Toxicology

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.

Our toxicologists are responsible for providing expertise into non-clinical and clinical development plans, toxicology (TK), clinical pharmacology and PKPD studies. Our Scientists support projects for Certara's clients by working in teams with other associates, expert modellers or statisticians, epidemiologists, health outcomes researchers, or drug development consultants. Qualified candidates will have the ability to work on a variety of projects and data types, and may provide oversight of associates.

• Design programs to support INDs, NDA/BLAs and postregistration studies.
• Outline studies and in partnership with clients, identify CROs to run these studies; manage the study data/information analysis with our client for draft reports and finalize with client.
• Conduct literature searches and triage results
• Prepare content of regulatory documents for filing.
• QC content of regulatory documents
• Assist toxicology lead(s) in preparing client response to any regulatory inquiries related to nonclinical studies.
• Support toxicology lead(s) on cross-functional drug development teams.

• PhD or equivalent in Pharmacology or Toxicology, or related field; with typically 2 or more years of post-doctoral experience in a drug development company, consulting organization, CRO, or regulatory agency (e.g., FDA) or;
• Master's level degree in Pharmacology or Toxicology, or related field, with approximately 3-5 years of relevant experience in a drug development company, consulting organization, CRO, or regulatory agency (e.g., FDA).
• Experience in nonclinical safety and TK/PK data analysis and summarization, with strong quantitative skills
• Experience in the design and outsourcing of GLP and non-GLP toxicology and safety pharmacology studies is a plus
• Knowledge of relevant Global regulatory guidelines/requirements from FDA, EMEA, PDMA and Health Canada.
• Drug development experience across in at least one therapeutic area, such as oncology, CNS, inflammation, metabolic disease, or cardiovascular is a plus
• Knowledge/experience in the generation of safety margins based on nonclinical toxicity findings and target clinical exposure data
• Experience authoring the relevant nonclinical sections of IND's and NDA/BLA's is a plus

Skills & Abilities:

• Ability to work in cross functional project teams
• Good project management skills
• Strong communications skills
• Excellent team player and team leader skills

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.