Principal Scientist , Preclinical Development Position Description
- Preclinical Development is responsible for conducting toxicology, pharmacokinetic, ADME, safety pharmacology and pharmacology studies in support of repurposing and repositioning drugs.
- This group represents the company in all nonclinical activities, and assists clinical and regulatory in support of 505(b)(2) submissions.
- The incumbent will have a significant role in the drug development process beginning with supporting early formulation and continuing through the entire drug development value chain resulting in successful registration and marketing approval.
- Therefore, the successful candidate will be responsible for their own projects, from conception through program design, execution, and preparation of all documentation related to the IND, NDA and communicate unambiguous critical and significant project information to various bodies including project teams, corporate leadership, consultants and regulatory agencies.
- This position requires a strong background in regulatory toxicology including extensive knowledge and understanding of Good Laboratory Practices, FDA Guidance's, and ICH Guidelines.
- The individual will need to adapt to new challenges, take risks, and address/resolve toxicological/pharmacologic/pharmacokinetic issues arising in drug development programs in order to adequately assess the relevance of any findings to human safety.
- They will be responsible for the conduct and coordination of all toxicological/ pharmacokinetic and nonclinical safety evaluations of development candidates with external CRO's and academic labs consultants, and development partners.
- Therefore, attention to detail and ability to allocate resources, and meet deadlines is essential.
- They must be able to manage multiple research activities, provide and accept input on data interpretation, foster a spirit of team collaboration, and be able to work well with others.
- This individual must be a strong problem solver who is highly organized with the ability to thrive and to lead in an environment with rapidly changing priorities, therefore, strong interpersonal skills with an ability to develop solid, long-term relationships and to work effectively in a team setting/matrix-type organization critical.
- They must be able to build strong scientific collaborations with internal/external groups within both the academic and industrial sectors with the intent of enhancing capabilities.
- This individual will report directly to the AVP of Preclinical Development.
- This is a challenging position within a young and growing company.
- MS required; PhD preferred in Toxicology and/or Pharmacokinetics or relevant field with a minimum of ten years with an MS or five years with a PhD in the Pharmaceutical Industry.
- They must have a demonstrable track record in conducting drug safety assessment studies, management of multiple scientific projects and a solid track record of sound scientific interpretations and risk assessments.
- Further the successful candidate will have an in depth understanding and working knowledge of regulatory toxicology for US and international regulatory drug development and approval process.
- Knowledge of biochemical and mechanistic toxicology, pharmacokinetics, pharmacology, biology of disease, and experimental pathology.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.