Assists in the development, evaluation, planning and execution of clinical studies
Ensures scientific integrity and interpretation of study data of a clinical development program
Contributes to candidate development projects through early and/or late phase development
Collaborates closely with Medical Director(s) (MDs) to provide scientific expertise necessary to design and deliver on clinical studies
Maintains compliance in accordance with FDA, EMEA, ICH and GCP guidelines
Supports clinical/medical data review, including safety monitoring and activities that ensure patient safety

Requirements

BS/MS/PhD/PharmD in a related area
≥ 6 years of pharmaceutical clinical drug development experience
Experience in one or more of the following therapeutic areas is preferred – cardiovascular, renal, metabolic disease
Basic knowledge of clinical development process, regulatory requirements and ICH/GCP guidelines

Benefits

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical studies developmentdata evaluationclinical development programsafety monitoringregulatory complianceclinical data reviewtherapeutic area knowledgeclinical development processICH guidelinesGCP guidelines

Soft Skills

collaborationscientific expertisecommunicationplanningexecutioninterpretation of dataproblem-solvingattention to detailorganizational skillsleadership

Certifications

BSMSPhDPharmD