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Miles
Km80.5

Scientist, Clinical Pharmacology

Otsuka America Pharmaceutical, Inc.

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Location: Rockville, MD Posted Date: 4/15/2013 Position Type: Full time Job Code: 2824 Required Education: Doctorate/PhD

Description

Help develop and implement clinical pharmacology programs that support product development, registration, differentiation and personalization. Scientist will interact with team members to identify and define mechanisms of action, biomarkers and new drug targets. Scientist is responsible for helping design clinical pharmacology trials and selecting pharmacokinetic (PK)/pharmacodynamic (PD) /biomarker assessments in all phases of development, PK/PD analysis and reporting, contribute relevant sections to regulatory filings, work with pharmacometricians to develop PK/PD models and contribute to commercial strategies.

Key Job Responsibilities
Key job responsibility Percentage of time Importance rank *
• Help develop and execute Clinical Pharmacology strategy for given programs
• Collaborate with clinical development to design and implement innovative early clinical development strategies from first-in-man through pharmacological/biomarker proof of concept (Phase Ib/Phase 2a)
• Identify new drug targets and biomarkers through analysis of drug mechanism of action and patient characteristics (eg, phenotype, genotype, etc)
• Provide input to project teams on biopharmaceutics, pharmacogenomics and biomarkers.
• Help design clinical pharmacology trials and is responsible for the generation of protocol outlines.
• Coordinates with bioanalytical scientists on types of analytes, limits of quantitation, and response range required of the bioanalytical methods used to support clinical trials.
• Analyzes PK and PD data using non-compartmental and compartmental methods and prepares PK and PD sections of study reports and regulatory submissions documents.
• Works with pharmacometricians to develop PK/PD/efficacy models.
• Prepares and may present PK/PD information to internal clinical development and commercialization teams, regulatory agencies, scientific boards and at investigator meetings.
• Manages outsourcing of PK analyses and reports, including SOW and oversight.
• Provides input to Department Head on departmental practices, templates and workflows.

Requirements

Required:
• Able to work with minimal supervison and think independently.
• Has demonstrated success in technical proficiency, scientific creativity and collaboration with others.
• Has worked on problems in which analysis of data requires evaluation of identifiable factors
• Solid understanding of clinical pharmacology with knowledge of PK / drug metabolism and human physiology
• Mathematical computing skills
• Ability to create written summaries and presentations using MS Office (Word, Excel, Powerpoint, Outlook) and Sigma Plot
• Experience with PK/PD software (eg, WinNonlin) and plotting software (eg, SigmaPlot, etc)
• PhD or PharmD +0-5 years PK/PD experience

Preferred:
• Knowledge of pharmacology related to CNS, Oncology or Cardio-renal
• Knowledge of PK/PD modeling (eg, physiologically-based PK, population PK)
• Post-doctoral clinical pharmacology experience or 1 to 2 years PK/PD experience in pharmaceutical industry
• Experience in the preparation of summaries and reports for regulatory submissions
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