Clinical Pharmacology Fellow
This 2 year Fellowship is intended to provide a PhD-qualified scientist with limited or no industry experience the opportunity to initiate a clinical pharmacology career in the pharma industry. The Fellowship will not be affiliated with any academic or government institution and will be a full-time role based within the Clinical Pharmacology and Early Development (CPED) group at CSLB, King of Prussia, PA (USA). The Fellowship will be conducted on a Contractor basis, and may be extended beyond the 1 year period based on need and merit.
Candidates for this role will have experience in the clinical pharmacology arena (including pharmacokinetics/pharmacometrics). Industry experience will not be compulsory. A high degree of hands-on pharmacometrics (modeling & simulation, and possibly systems biology) work will be undertaken by the Fellow; though exposure to more general clinical pharmacology work will likely occur.
By the end of the Fellowship, the Fellow should be well placed to commence a career as a Clinical Pharmacologist (or Pharmacometrician) in industry.
The Clinical Pharmacology Fellow supports the functional pharmacometric contributions to clinical program documents (study synopses, protocols, Investigators Brochures, clinical study reports, conference abstracts, regulatory submission documents, clinical development plans, statistical analysis and data analysis plans, internal and external scientific meeting presentations and peer-reviewed publications).
•Pharmacometrics: perform selected PK/pharmacometrics analyses (WinNonlin, population PK, pk/pd modelling, simulations etc.) and QCing of internal pharmacometrics analyses.
•Provide scientific support to a clinical pharmacologist
•Participate in review and interpretation of study subject-level clinical pharmacology data.
•Provide literature search support for CPP function.
•Assist in maintaining and be possible expert user of CPEDs LINUX-based pharmacometrics analysis platform.
Requirements:
Position Qualifications and Experience Requirements
Education
•PhD in life science/healthcare required, together with a proven ability to undertake pharmacokinetic/pharmacometric analyses.
Experience
•Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing own timelines.
•Demonstrable knowledge of clinical pharmacology and advanced pharmacokinetic principles.
•Proven ability to undertake non-compartmental PK, population PK, and more complex pharmacometric analyses (including demonstrable relevant software skills), and interpretation of resultant output. Experience in PK/PD modeling and conduct of simulations essential.
•Strong research skills, knowledge of scientific analysis, data mining, and basic statistical analysis principles required.
•Experience in analyzing and presenting research results to scientific and professional audiences.
•Excellent communication and presentation skills required. Experience in effective medical writing desirable.
Worker Type:
Employee
Worker Sub Type:
Regular
