Clinical Services Manager, PhD

·*Fully Remote - MUST work EST schedule*

Primary Responsibilities
• Provide clinical pharmacology expertise and strategic leadership in the review, analysis, and interpretation of study results for clinical pharmacology studies (e.g, DDI, BA/BE, organ impairment studies, etc.) and clinical pharmacology elements in efficacy/safety trials.
• Conduct literature reviews as needed for study rationale and interpretation of study data
• Provide technical oversight and work in conjunction with medical writing to support regulatory submission document authoring
• Review PK TFLs and pharmacometrics reports and provide interpretation

Education and Professional Preferred Experience
• PhD in Pharmaceutical Sciences, Pharmacokinetics, Clinical Pharmacology or related fields
• 8+ years of relevant experience
• Demonstrated success in executing clinical pharmacology programs for small molecule therapeutics
• Strong knowledge of PK/PD principles, ADME concepts and FDA Office of Clinical Pharmacology regulatory guidances
• Prior NDA submission experience (CTD Sections 2.7.2, 2.7.2, 2.5)
• Strong understanding of noncompartmental and model-based PK and PK/PD analyses
• Scientific writing skills are essential