Athenex, Inc. is seeking versatile individuals of all education/experience levels with strengths and in clinical pharmacology, drug metabolism, bioanalytic chemistry, PK/PD modeling, and translating non-clinical data to predicting and explaining clinical data.
Essential Job Functions/Responsibilities May Include:
- Represent and/or work within the clinical pharmacology team and provide PK, PK/PD, and drug-metabolism expertise to project teams.
- Interact with pre-clinical scientists in analyzing and interpreting drug metabolism and pharmacologic data.
- Analyze and interpret drug metabolism and ADME data.
- Analyze and interpret clinical pharmacology data.
- Be able to work with a team to develop and utilize PBPK and nonlinear mixed effects models.
- Work with contract research laboratories (CROs) for metabolism and bioanalytic activities and assure GxP compliance.
- Create clinical pharmacology drug-development plans.
- Author reports/chapters of reports including those intended for regulatory submission. For example, clinical study reports (CSRs), investigator brochures (IB), investigational new drug application (IND), new drug application (NDA), bioanalytic, and clinical pharmacology chapters.
- Support clinical protocols and protocol execution, including lab manual authoring, pharmacokinetic (PK) sample logistics, and site initiation activities.
- Collaborate with other line functions and all members of the Clinical Pharmacology department.
- Exhibit versatility in accordance with the ebbs and flow of shifting needs in accordance with the various stages of the drug development efforts.
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.