Head of Analytical Chemistry & DMPK
Responsible for and directs bioanalytical analysis of nonclinical and clinical samples, and preclinical and clinical pharmacokinetics for new drug candidates. Manages and directs preclinical studies including pharmacokinetic and drug disposition studies for the purpose of developing lead compounds for first in human trials, and for later-stage development. .Responsible for organizing and reporting all data generated from bioanalytical analysis and drug disposition studies. Coordinate development of drug candidates with senior management and corporate partners.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Direct and coordinate the analysis of drug substance, drug metabolites or other endogenous analytes in support of ongoing clinical and preclinical studies. This work is achieved through working with outside vendors.
- Coordinate the the development of ELISA, HPLC,LC/MS, LC/MS/MS, and UV methods for drug substance, drug metabolites or other endogenous analytes in support of ongoing projects in applicable biological and aqueous matrices.
- Analyze preclinical and clinical pharmacokinetic/toxicokinetic data with software, such as WinNonLin, PRISM and Excel.
- Propose non-clinical studies to understand the absorption, distribution, metabolism and excretion (ADME) of drug development candidates.
- Responsible for the ADME content of INDs, NDAs and other regulatory submissions.
- Responsible for the bioanalytical content of INDs and NDA. Works closely with clinical and pharmaceutical development, and provides preclinical and pharmacokinetic support to drug development teams.
- Display strong leadership and interpersonal skills, able to problem-solve using personal judgment and work independently
- Ability to meet deadlines, accomplish work in order of priority and adjust to new situations.
- Ability to use software packages, e.g. spreadsheets word processing (Excel, Word).
- Excellent verbal and written communication skills
- Detail-oriented with meticulous oversight, coordination, tracking abilities, and long range planning.
- Knowledge of contract research organizations and their capabilities with regard to bioAnalysis, pharmacokinetic and drug disposition studies.
- Must be an excellent time manager.
- Ph.D. in a biological science is preferable.
- 15-20 years of experience within the laboratory setting, with development and validation of bioanlytical and analytical assays
- 15-20 years experience of implementing drug disposition studies relevant to new drug development.
- 15 years experience in a regulated environment.
- Strong interpersonal skills and ability to work effectively in team environment.
Top 3 to 5 Technical Skills:
- Extensive knowledge of regulatory guidelines with regard to bioanalysis and drug disposition
- Extensive knowledge of GLP regulations and bioanalytical analysis
- Extensive knowledge of drug disposition gained from on-the job experience as well as technical reading.
- Organize and report bioanalytical data
BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local laws.
The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.