Responsible for scientific oversight, data integrity and quality of clinical trial(s) in support of the development strategy for programs within Oncology portfolio
Clinical development expert for assigned studies maintaining current scientific and clinical knowledge in specific therapeutic and disease area(s)
Effectively partner with clinical and medical colleagues, clinical operations and other functional lines for successful implementation and execution of clinical trial(s)
Represent the study team in governance meetings, authors protocols, study level informed consent documents
Set the clinical data review strategy and lead the team in collection of quality data and review of emerging clinical data and trends
Analyze the emerging safety profile of the drug, keeping clinical and safety colleagues informed of changes in safety profile

Requirements

PhD/Pharm D in a relevant Science discipline and minimum of 2 years Clinical Research experience in industry/CRO, OR MS in a relevant Science discipline and minimum of 3 years of Clinical Research experience in industry/CRO OR BA/BS in a relevant Science discipline and minimum of 5 years Clinical Research experience in a similar role in industry/CRO
Clinical Research experience in the phase 2 - 3/pivotal space in Oncology
Excellent knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations
Extensive understanding of related disciplines, e.g., Clinical Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-clinical, Pharmacology, Quality Assurance
Experience working on large data sets
Proficiency with Microsoft Office and relevant scientific software
Effective communication, presentation, and organizational skills to ensure coordinated and timely delivery
Experience leveraging a variety of communication tools and techniques to communicate results
Experience solving problems collaboratively and handling conflict constructively
Track record of scientific productivity as evidenced by publications, posters, abstracts and/or presentations
Experience working proactively and independently, organizing tasks, time and priorities of self and others
Experience building partnerships across the company to achieve the needs of the program

Benefits

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Applicant Tracking System Keywords

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Hard Skills & Tools

Clinical ResearchOncologyData IntegrityClinical ProceduresICH GuidelinesGCPFDA RegulationsEMA RegulationsBiostatisticsPharmacology

Soft Skills

Effective CommunicationPresentation SkillsOrganizational SkillsProblem SolvingConflict ResolutionCollaborationTime ManagementProactive Work EthicIndependencePartnership Building

Certifications

PhDPharm DMSBABS