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Clinical Services Director
2 months ago
We are seeking a highly skilled Clinical Services Director to join our team at A.P.R., Inc. (AlphaProTemps). This is a unique opportunity to leverage your expertise in clinical pharmacology and pharmaceutical sciences to drive strategic leadership and technical oversight in the review, analysis, and interpretation of study results.
Key Responsibilities- Provide clinical pharmacology expertise and strategic leadership in the review, analysis, and interpretation of study results for clinical pharmacology studies, including DDI, BA/BE, organ impairment studies, 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.
- 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.
A.P.R., Inc. (AlphaProTemps) is a specialized staffing agency providing professional staff augmentation services, including temporary labor, contract sourcing, professional & technical niches, vendor-on-site, and managed service programs.
