Oncology Late Stage Clinical Scientist (Non MD, Director)

Role Summary

Oncology Late Stage Clinical Scientist (Non MD, Director) - 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.

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 workgroups aimed at optimizing PFE clinical development procedures; may be a subject matter expert or business process owner for a relevant SOP or procedure.

Qualifications

• 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, 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

Preferred Qualifications

• Experience in Hematology Oncology

Skills

• Demonstrates strong scientific and clinical understanding in oncology
• Autonomous delivery, problem-solving, and agile decision-making
• Effective collaboration and stakeholder management
• Communication and presentation excellence
• Strategic thinking and data-driven decision making

Education

• PhD/Pharm D or MS or BA/BS in a relevant science discipline as listed in qualifications

Additional Requirements

• Work Location: Hybrid