Oncology Clinical Development Scientist – Director

Responsibilities

• Scientific oversight, data integrity and quality of clinical trial(s)
• Clinical development expert for assigned studies maintaining current scientific and clinical knowledge
• Effectively partner with clinical and medical colleagues for successful implementation of clinical trial(s)
• Author protocols, study level informed consent documents
• Contribute to authoring of clinical study reports, regulatory responses
• Analyze the emerging safety profile of the drug
• Lead the team in the collection of quality data and review of emerging clinical data and trends

• PhD/Pharm D in a relevant Science discipline and minimum of 5 years Clinical Research experience in industry/CRO, OR MS in a relevant Science discipline and minimum of 7 years of Clinical Research experience in industry/CRO OR BA/BS in a relevant Science discipline and minimum of 10 years Clinical Research experience in a similar role in industry/CRO
• Clinical Research experience in the phase 3/pivotal space in Oncology
• Experience leading a team
• Excellent knowledge of clinical procedures, ICH guidelines, GCP
• 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
• 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
• Experience building partnerships across the company