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 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.
• 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 data, present and discuss relevant data to appropriate teams, governance bodies, and other 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; 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 with at least 2 years of clinical research experience in industry/CRO, or MS with at least 5 years, or BA/BS with at least 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 regulatory submission, inspection, and approval.
• Excellent knowledge of clinical procedures, ICH guidelines, GCP; 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 for coordinated and timely delivery.
• Experience leveraging diverse communication tools to communicate results.
• Experience solving problems collaboratively and handling conflict constructively.
• Track record of scientific productivity (publications, posters, abstracts, presentations).
• Experience working independently and managing priorities; ability to build partnerships across the company.

Skills

• Strong collaboration and leadership capabilities; ability to influence and coordinate across functions.
• Strategic thinking with data-driven decision-making and risk management.
• Proactive, autonomous workstyle with strong time management.

Education

• PhD/PharmD or MS or BA/BS in a relevant science discipline (as listed in Minimum Qualifications).

Additional Requirements

• Hybrid work location: live within commuting distance; on-site approximately 2.5 days per week.