Overview

About Certara

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 Toxicology Sr. Directors support projects for Certara’s clients by working in teams with other drug development functional experts, including where relevant CMC, DMPK, clinical pharmacology, clinical science, pharmacometrics and biostatistics. Sr. Directors will have the ability to work on a variety of projects, therapeutic areas, treatment modalities and data types, and may supervise and provide oversight of associates.

Sr. Directors must be recognized experts in applied toxicology to support drug development decision making, drug safety assessment, data review and summary, and regulatory interactions. Experience with at least 6 nonclinical development programs, including both small molecules and biologics (mAb, RNAi, proteins, gene therapies, etc), is expected.

Responsibilities

Primary Responsibilities include collaborating with senior staff to:

Contribute to due diligence and gap analysis of nonclinical data packages. Design programs to support INDs, NDA/BLAs and post-registration studies. Outline studies and in partnership with clients, identify CROs to run these studies; manage the data/information analysis with our client to draft reports and finalize with client. Prepare content of regulatory documents for filing. Design investigative programs to address toxicology findings/issues/circumstances to determine human relevance. Represent client to regulatory authorities (as needed/requested). Advise clients on prioritization of their portfolio. Serve on cross-functional drug development teams as toxicology lead. Provide toxicology overview of full portfolio with potential investors to assist clients in obtaining funding. May manage a limited number of direct reports. Influencing the disciplines of pharmacology and toxicology in the context of drug development.

Qualifications

PhD in quantitative Pharmacology or Toxicology, or related field. Pertinent Board Certification desirable. At least 8-10 years post doctorate experience in a drug development company, CRO, consulting organization, or FDA (R&D, nonclinical drug development). Knowledge or experience with TK/PK data analysis and summary, with strong quantitative skills is preferred, but not required. Experience in the design and outsourcing of GLP and non-GLP toxicology and safety pharmacology studies. Experience in addressing comments/questions from Global regulatory agencies is desired, ideally from FDA, EMEA, PDMA and Health Canada. Drug development experience across multiple therapeutic areas, such as oncology, CNS, inflammation, autoimmunity, metabolic disease, or cardiovascular, with small molecules and biologics. Experience with development of pediatric, orphan, and/or ultra-orphan products is a plus. Experienced 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, NDA/BLA’s, and other regulatory submission documents (SPA, pre-IND/Type B/Type C meeting briefing documents etc. Ability to lead and work in cross functional project teams. Demonstrated experience leading and managing projects. Has served as a leader on teams and strongly demonstrated ability to work and excel in team collaboration. Excellent written, verbal, and inter-personal communication skills. Possess a strong focus on influencing at high levels, innovation, and customer centricity. Strong initiative, self-motivation, and coordination with other team members. Strong client and alliance management skills. Ability to work across functions to implement company initiatives. Proficient in Microsoft Word and Power Point.

EEO

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.