Associate Director - Clinical Pharmacology
5 days ago
Description
• Develop clinical pharmacology strategy suitable for target product profile (TPP) • Lead the design, execution, interpretation, and reporting of Phase 1 clinical pharmacology studies • Serve as clinical pharmacology lead on studies and project teams • Collaborate with DMPK and clinical research teams • Determine scope, design, plan, and analyze phase 1-4 pharmacokinetic and pharmacodynamics studies • Provide clinical pharmacology expertise to the project team • Accountable for the analysis and interpretation of PK and PK/PD data • Prepare regulatory documents and participate in drafting publications
Requirements
• Pharm. D./Ph.D. or MS in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Chemistry, Biochemistry, or related field • 10 years of significant industry experience in conduct and/or oversight of clinical pharmacology studies and data analysis • 7 years of experience in a supervisory role • Familiarity with all stages of clinical drug development • Demonstrated ability to independently develop clinical pharmacology strategy • Expertise/experience in multiple clinical pharmacology areas preferred • Experience in preparation of INDs, CTAs, NDAs, and MAAs • Competent in the use of PK and PK/PD software tools such as Phoenix • Strong written, presentation, and verbal communication skills
Benefits
• Discretionary annual target bonus • Stock options • ESPP • 401k match • Health insurance plans (medical, dental, vision, basic life) • 20 days of PTO • 10 paid holidays • Winter company shutdown
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