Oncology Late Stage Clinical Development Scientist, Senior Manager; Non MD

Position: Oncology Late Stage Clinical Development Scientist, Senior Manager (Non MD) -- Multiple Openings
Position Summary

You will be responsible for scientific oversight, data integrity and quality of clinical trial(s) in support of the development strategy for programs within the Late-Stage Oncology portfolio.
Key Responsibilities
• Clinical development expert for assigned studies maintaining current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment.
• Effectively partner with other clinical and medical colleagues, clinical operations and other functional lines for the successful implementation and execution of the clinical trial(s) within the assigned program.
• Responsible for scientific oversight, data integrity and quality of the clinical trial(s).
• Represent the study team in governance meetings and submissions, partners with/supports the Development lead/Medical Director regarding study and disease area strategy.
• Author protocols, study level informed consent documents, and contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents; supports preparations for Health Authority meetings, participates as appropriate.
• Set the clinical data review strategy and leads the team in the collection of quality data and review of emerging clinical data and trends; reviews and queries data; presents and discusses relevant data to appropriate teams, governance bodies, and other internal and external stakeholders.
• In close partnership with medically qualified colleague/s, analyze the emerging safety profile of the drug, keeping the clinical and safety colleagues informed of changes in the safety profile as they occur in the assigned trial(s).
• Follow relevant SOPs and regulations, has an excellent understanding of and complies with applicable trainings, seeks opportunities to further improve quality and efficiency of clinical procedures; leads or actively participates in portfolio- and enterprise level work groups aimed at optimizing PFE clinical development procedures; may be a subject matter expert or business process owner for a relevant SOP or procedure.
Minimum Qualifications
• 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 5 years of Clinical Research experience in industry/CRO OR
• BA/BS in a relevant Science discipline and minimum of 7 years Clinical Research experience in a similar role in industry/CRO
• Experience in oncology clinical trial development, solid tumor and/or heme
• Clinical Research experience in the phase 3/pivotal space in Oncology, ideally on the side of the sponsor and with a track record of successful regulatory submission, inspection, and regulatory approval.
• 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.
COMPETENCIES FOR…