Great opportunity to join our global PK team in a work from home (from anywhere in North America) or Richmond, VA office-based role!
The Senior Pharmacokineticist is responsible for the design, analysis and interpretation of pharmacokinetic, bioavailability, bioequivalence and pharmacodynamic clinical trials. He/she will prepare and oversee the generation of final reports (provided to sponsors for submission to FDA).
The Pharmacokinetics Department provides the clinical PK support necessary to elucidate the pharmacokinetics and PK/PD relationships in support of our client's new and generic drug development efforts. The Senior Pharmacokineticist position provides both PK consultation and pharmacokinetic analyses. In addition to managing his or her own projects, the Senior Pharmacokineticist will work with our pharmacokinetics team to assist our clients in the design, analysis, and interpretation of PK, PK/PD and population PK studies.
This position requires experience in clinical pharmacokinetic research in a CRO or a pharmaceutical company. The individual filling the position is required to be flexible and extremely adaptive as part of the responsibilities. The position requires one to identify priorities and shift resources to complete initial projects needing immediate attention. The individual must also be able to work effectively on several projects simultaneously. The studies must be conducted according to FDA guidelines, to insure acceptance by FDA.
Education and Experience:
Ph.D. or PharmD with an emphasis on clinical pharmacokinetics
3 years in the Pharmaceutical, CRO industry or other relevant experience
Experience in management of pharmacokinetic programs with a proven record of accomplishment
Experience with medical, pharmaceutical, metabolism and clinical research concepts
Or equivalent combination of educations, training and experience that proved the individual with the required knowledge, skills, and abilities
Knowledge, Skills and Abilities:
Knowledgeable of FDA pharmacokinetic/bioavailability/bioequivalence criteria
Strong theoretical background in Pharmacokinetics with experience in PK/PD
Able to apply PK theory using SAS programming, WinNOnlin, MATLAB, NONMEM or other pharmacokinetic packages
Excellent organizational, communication, and problem-solving skills are required
PPD is an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group.