What are the responsibilities and job description for the Director, Toxicology position at Certara USA, Inc.?
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 Directors support projects for Certara's clients by working in teams with other associates, expert modelers or statisticians, epidemiologists, health outcomes researchers, or drug development consultants. Directors will have the ability to independently work on a variety of projects and data types, and may supervise and provide oversight of associates.
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 3 nonclinical development programs with small molecules, biologics (mAb, RNAi, proteins, gene therapies, etc), or both is expected.
Responsibilities
- 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)
- Assist client response to any regulatory inquiries to nonclinical studies
- Serve on cross-functional drug development teams as toxicology lead.
- May manage a limited number of direct reports
- Influencing the disciplines of pharmacology and toxicology in the context of drug development
Qualifications
- PhD in Pharmacology or Toxicology, or related field with a minimum of 4-6 years of post-degree experience in a drug development company, consulting organization, CRO, or FDA
- Pertinent Board Certification desirable
- 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 expected
- Drug development experience across multiple therapeutic areas, such as oncology, CNS, inflammation, metabolic disease, or cardiovascular
- 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 and NDA/BLA's
Skills & Abilities:
- Ability to lead and work in cross functional project teams
- Strong project management skills
- Excellent written, verbal, and inter-personal communication skills
- Strong initiative, self-motivation, and coordination with other team members
- Excellent team player and demonstrated team leader skills
- Strong client and alliance management skills
- Proficient in Microsoft Word and Power Point
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.
Certara is an Equal Opportunity Employer. Certara does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.