Bengaluru IN Valence Block – Bengaluru – IN

JOB DESCRIPTION

The Pharmacokineticist is responsible for the design, analysis and interpretation of pharmacokinetic, bioavailability, bioequivalence and pharmacodynamic clinical trials and assists with the preparation of final reports (provided to sponsors for submission to FDA). Clinical Pharmacology 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 Pharmacokineticist position is a “hands-on” position that provides both PK consultation and pharmacokinetic analyses. In addition to managing his or her own projects, the 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. The ideal candidates will have the experience, insight and skills necessary to provide interpretation of complex data and will be able to present this interpretation in a format and style that is compatible with client and FDA specifications. This position requires experience (at least academic experience) in pharmacokinetic analyses and modeling. 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. Clinical bioavailability studies must be organized so that they are conducted on schedule. Similarly, they must be conducted according to FDA guidelines to insure acceptance by FDA.

Job Qualification

Education and Experience:Ph.D. or PharmD., with an emphasis on clinical pharmacokinetics0-3 years in the Pharmaceutical or CRO IndustryMust have experience with pharmacokinetic, medical, pharmaceutical and research conceptsExperience required in pharmacokinetic analysis and modeling; should have a proven record of accomplishments and publicationsKnowledge of FDA pharmacokinetic /bioavailability/ bioequivalence criteriaStrong theoretical background in Pharmacokinetics and some experience in PK/PD modelingMust be able to apply PK theory using SAS programming, WinNonlin, MATLAB, NONMEM or other pharmacokinetic packages Knowledge, Skills and Abilities:Excellent communication skills, both written and oralCompetent in pharmacokinetic theory and able to apply PK theory using SAS programming, PCNONLIN and other pharmacokinetic/statistical packagesFamiliarity with pharmacokinetic modelingExcellent organizational skillsSelf-starter, able to initiate work and motivate othersAbility to keep others informed of progressExcellent problem solving capabilities and organizational skills Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.

Apply : https://careers.ppdi.com/jobdetails/ppd_external/200576?searchable=%5B%5D&section=ppd_external