Senior Scientist, Clinical Pharmacology

Senior Scientist, Clinical Pharmacology
Company:

(Confidential)


Senior Scientist, Clinical Pharmacology

Details of the offer

Reporting to the Senior Director, Translational Drug Development, the Senior Scientist will work flexibly across a variety of projects and have expertise in pharmacokinetics (PK) and pharmacodynamics (PD) modeling and a proven track record in designing clinical pharmacology studies (eg, drug:drug interactions (DDI), food:effect, bioavailability/bioequivalence, mass:balance, special population, pediatric and geriatric populations, abuse liability, alcohol tolerance and gender studies) along with evaluating drug models in support of the Companys IND/CTA and NDA submissions and prescription drug labeling (PDL).

RESPONSIBILITIES:

Design clinical pharmacology studies, develop PK analysis plans (PAP) and determine the scope of modeling and simulations required to support Phase 1 to Phase 3 clinical trials and beyond (ie, Phase 4)
Perform non:compartmental analyses (NCA) along with compartmental, PK/PD and population PK modeling in support of drug development and ensure appropriate data analysis and simulation are performed to support trial design and progression
Review clinical study reports (CSRs), tables, figures and listings (TFLs), statistical analysis plan (SAS) and other clinical pharmacology components of project plans
Author PK sections of CSRs, regulatory modules and regulatory documents (IBs, briefing packages, INDs, CTAs, NDAs, etc.)
Conduct comprehensive analysis of in vitro DDI data to identify data gaps from regulatory and scientific perspectives for both modeling and conducting human DDI studies
Provide written responses to regulatory inquires related to PK/ADME, PAP, PK/PD and other aspects of clinical pharmacology, particularly DDI
Write scientific publications (posters, peer:reviewed manuscripts, etc.) and prepare/give scientific presentations consistent with development strategies and publication plans
Collaborate with toxicology team on the scientific aspects of clinical pharmacology study protocol development
Maintain knowledge of relevant scientific and regulatory practices, guidance and trends, and ensure that clinical pharmacology aspects of development programs are contemporary

QUALIFICATIONS:

PhD in pharmacology, pharmacokinetics, pharmacometrics, PharmD or other professional doctorate in pharmaceutical sciences or a related scientific discipline with a minimum 10 years of industry experience
Extensive understanding and hands:on experience with modeling and simulation in drug development (ie, compartmental and NCA, PK/PD, population PK, mechanistic modeling)
Expert in using modeling and simulation software (eg, WinNonlin Phoenix, NONMEM, GastroPlus, PKSIM, SimCYP, SAS, R,) and good knowledge of statistics
Thorough knowledge and understanding of the clinical research drug development process, investigational trials, impact of clinical pharmacology content in PDL, and regulatory requirements and filings
In depth knowledge and thorough understanding of in vitro DDI both in terms of enzymes and transporters and modeling aspects of these data to predict in vivo human DDI and identify data gaps
Expertise in clinical pharmacology trials in pediatric population, in PBPK modeling and simulation and in bioanalytical method development and validation along with handling the bioanalysis aspects of clinical trials are highly desirable
Ability to work independently and in multidisciplinary teams with excellent written and verbal communication skills


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