Lee Hecht Harrison Nederland B.V.
Clinical Services Manager (Non-Clinical - Administrative)
Lee Hecht Harrison Nederland B.V., Boston, Massachusetts, us, 02298
Clinical Services Manager Needed! (Remote - Eastern Time Zone)
LHH has a client in Boston, MA (Remote) who needs a Clinical Services Coordinator on a contract opportunity!This is a great chance to get in with a reputable company to advance your career!Job Overview: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.Job Title:
Clinical Services ManagerLocation:
Boston, MA (Remote - Must work EST hours)Pay:
$85-$95/hourType:
ContractIndustry:
BiopharmaceuticalsIf you are interested in the Clinical Services Manager role, please apply now!
#J-18808-Ljbffr
LHH has a client in Boston, MA (Remote) who needs a Clinical Services Coordinator on a contract opportunity!This is a great chance to get in with a reputable company to advance your career!Job Overview: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.Job Title:
Clinical Services ManagerLocation:
Boston, MA (Remote - Must work EST hours)Pay:
$85-$95/hourType:
ContractIndustry:
BiopharmaceuticalsIf you are interested in the Clinical Services Manager role, please apply now!
#J-18808-Ljbffr