We are seeking an enthusiastic and highly motivated Pharmacokinetics Associate/Scientist. This individual will support the development of novel drug candidates by design, analysis, and interpretation of non-clinical and clinical pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/PD) studies. The successful candidate must have experience in the field of drug discovery or development or relevant area of expertise. Excellent written and oral communication skills, as well as strong organizational skills are essential. Flexibility and adaptability are also necessary.
- Design, analyze, and interpret non-clinical and clinical PK/PD studies to better understand the drug candidates and predict PK/PD in humans
- Interact with multidisciplinary teams (including bioanalytical sciences, protein engineering, research, toxicology, biomarker, and clinical) to meet project goals and timelines
- Assist outsourced PK/PD analyses and provide updates to the Clinical Pharmacology representative and project team
- Prepare PK, PK/PD, and/or modeling and simulation components of study protocols, documents, and reports for internal governance committees and regulatory submissions
Qualifications and Requirements:
- BS or MS (at least 3-5 years experience) or PhD (at least 0-2 years experience), in pharmacology, pharmacokinetics, pharmaceutical science, bioengineering, chemical engineering, or related disciplines is required.
- Strong knowledge and experience in non-clinical and clinical PK and PK/PD of large molecule therapeutics are highly desired.
- Working knowledge of PK/PD software (e.g., WinNonlin, NONMEM, R, MATLAB etc) and proficiency in Microsoft Office software are required.
- Ability to analyze and critically assess PK/PD data is essential.
- The candidate must have excellent interpersonal skills with an ability to work effectively in a team setting and excellent oral and written communication capabilities.