Clinical PharmacologistTalent Groups • Waltham, MA, US
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Clinical Pharmacologist
Talent Groups • Waltham, MA, US
[job_card.variable_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]Education : Ph.D. or Pharm D in Pharmaceutical Sciences, Pharmacometrics, or related field with 3+ years or 4+ years of experience in pharmaceutical industry. Demonstrated experience in serving as clinical pharmacology lead on development programs. PK Experience : The incumbent should have a strong understanding of pharmacokinetic theory, compartmental modeling and simulation, and statistical approaches utilizing the latest computational approaches and tools. Knowledge : Sound working knowledge of the cross-function interfaces that are important for efficient drug development, and a detailed understanding of non-clinical and clinical DMPK processes. Programming experience (Phoenix) is must; other programming experience (e.g., , Monolix, R, WinNonlin, SAS, Splus) is desirable. Regulatory : Current knowledge of FDA regulatory guidance related to nonclinical and clinical pharmacology; experience having direct interaction with FDA, including submission of IND, NDA and other regulatory documents is required. Writing : Experience in non-compartment and model-based PK and PK / PD analyses and inclusion of data in the preparation of manuscripts, study reports and sections of regulatory submission documents (e.g. : INDs, NDAs, CTDs) is required.
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