The Pharmacologist Lead will provide scientific support in the development of a wide range of novel and generic pharmaceutical products for the global Product Development portfolio. The Pharmacologist Lead will use prior training and experience to design, analyze and interpret results of studies including, but not limited to, PK, efficacy, bioequivalence and safety studies. The Pharmacologist lead will conduct literature reviews and author expert reports to support product registrations.
Work with Technical Leads and Clinical Operations to design clinical and laboratory studies supporting the development of new and generic drugs, analyze and interpret data from various study types, conduct literature reviews and modelling/simulation exercises to determine the PK/PD profile of drug development candidates in order to assist in portfolio process and drug development strategies. Identify appropriate efficacy models as needed, review study protocols for clinical and laboratory studies, prepare expert reports for submission to regulatory authorities in support of applications, assist with identification of qualified contract organizations to conduct studies, arrange for and oversee development and validation of bioanalytical methods as required. Conduct statistical analyses as needed to support the Product Development department and potentially other departments. Observe in-life procedures of laboratory studies to evaluate scientific validity.
Qualifications include PhD or MS in Pharmacology/Pharmacokinetics. Veterinary degree desirable. Minimum 5 years of experience in pharmacology/pharmacokinetic research (industry or academia). Significant experience in study design and data interpretation. Extensive understanding of PK/PD and bioequivalence. Experience performing PK and statistical analysis in WinNonlin or equivalent software. Experience in PK modeling and simulation. Strong background in bioanalysis is preferred. Strong analytical and organizational skills with the ability to handle multiple tasks and prioritize. Ability to communicate effectively with excellent written/verbal skills and strong technical writing capabilities. Some travel is required.
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