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

Role Summary

Oncology Late Stage Clinical Scientist (Non-MD, Senior Manager) responsible for scientific oversight, data integrity and quality of clinical trials in support of 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 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, participate as appropriate.
• 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 close partnership with medically qualified colleagues, 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, maintain understanding of and comply with applicable trainings, seek opportunities to improve quality and efficiency of clinical procedures; lead or participate 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 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
• 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 regulatory 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 a variety of communication tools to communicate results; able to solve problems collaboratively and handle conflict constructively.
• Track record of scientific productivity (publications, posters, abstracts, presentations).
• Experience working proactively and independently, organizing tasks, time and priorities of self and others.
• Experience building partnerships across the company to achieve program needs.

Skills

• Clinical development expertise in oncology; strong data review and interpretation capabilities.
• Stakeholder management and cross-functional collaboration.
• Scientific writing and regulatory documentation.
• Problem solving, adaptability, and strategic thinking.
• Leadership and ability to influence without direct authority.

Education

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

Additional Requirements

• Work Location Assignment: Hybrid role; live within commuting distance and on-site average of 2.5 days per week.