Oncology Late Stage Clinical Scientist (Senior Manager, Non MD)

Role Summary

Oncology Late Stage Clinical Scientist (Senior Manager, Non MD) responsible for scientific oversight, data integrity and quality of clinical trials 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.
• Partner with other clinical and medical colleagues, clinical operations and other functional lines for 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, partner with/support the Development lead/Medical Director regarding study and disease area strategy.
• Author protocols, study level informed consent documents, and contribute to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents; support preparations for Health Authority meetings.
• Set the clinical data review strategy and lead the team in the collection of quality data and review of emerging clinical data and trends; review and query data; present and discuss relevant data to appropriate teams, governance bodies, and other internal and external stakeholders.
• In partnership with medically qualified colleagues, analyze the emerging safety profile of the drug, keeping clinical and safety colleagues informed of changes in the safety profile as they occur in the assigned trial(s).
• Follow relevant SOPs and regulations; maintain trainings; seek opportunities to improve quality and efficiency of clinical procedures; lead or participate in portfolio- and enterprise level workgroups aimed at optimizing clinical development procedures; may be a subject matter expert or business process owner for a relevant SOP or procedure.

Qualifications

• Minimum Qualifications: PhD/PharmD in a relevant Science discipline with minimum of 2 years Clinical Research experience in industry/CRO, OR MS with minimum of 5 years, OR BA/BS with minimum of 7 years in a similar role.
• Clinical Research experience in the phase 3/pivotal space in Oncology, ideally on the sponsor side with a track record of successful regulatory submission, inspection, and approval.
• Excellent knowledge of clinical procedures, ICH guidelines, GCP, and familiarity with FDA, EMA, and global regulations.
• Extensive understanding of related disciplines (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 various communication tools to communicate results; strong problem-solving and conflict resolution abilities.
• Track record of scientific productivity (publications, posters, abstracts, presentations).
• Experience working independently and with others to organize tasks, time, and priorities; experience building partnerships across the company to meet program needs.

Skills

• Clinical development leadership
• Data integrity and quality oversight
• Regulatory understanding and submissions
• Safety signal analysis and pharmacovigilance collaboration
• Cross-functional collaboration and governance participation
• Scientific writing and document preparation
• Data review and trend assessment
• Project management and organizational skills

Education

• PhD/PharmD in a relevant Science discipline or MS/BA with equivalent experience as listed in Minimum Qualifications.

Additional Requirements

• Work Location Assignment: Hybrid role requiring living within commuting distance and on-site ~2.5 days per week.