Late Stage Oncology Clinical Scientist (Director, Non MD) Multiple Positions

Role Summary

Late Stage Oncology Clinical Scientist (Director, 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 clinical and medical colleagues, clinical operations and other functional lines for successful implementation and execution of the clinical trial(s).
• Responsible for scientific oversight, data integrity and quality of the clinical trial(s).
• Represent the study team in governance meetings and submissions; support the Development lead/Medical Director regarding study and disease area strategy.
• Author protocols, study level informed consent documents; contribute to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical/regulatory documents; support preparations for Health Authority meetings as appropriate.
• Set the clinical data review strategy; lead collection of quality data and review of emerging clinical data and trends; review and query data; present data to teams, governance bodies, and stakeholders.
• In partnership with medically qualified colleagues, analyze emerging safety profile of the drug; keep clinical and safety colleagues informed of changes in safety profile.
• Follow SOPs and regulations; seek opportunities to improve quality and efficiency; lead or participate in portfolio- and enterprise-level workgroups to optimize procedures; may be SME or process owner for a relevant SOP.

Qualifications

• PhD/Pharm D in a relevant science with minimum 5 years Clinical Research experience in industry/CRO, OR
• MS in a relevant science with minimum 7 years Clinical Research experience in industry/CRO OR
• BA/BS in a relevant science with minimum 10 years Clinical Research experience in a similar role in industry/CRO
• Clinical Research experience in phase 2-3/pivotal space in Oncology, ideally as sponsor with track record of regulatory submissions, 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; ability to communicate results using various tools
• Experience solving problems collaboratively and handling conflict constructively; track record of scientific productivity (publications, posters, abstracts, presentations)
• Experience working proactively and independently, organizing tasks and priorities; ability to build partnerships across the company

Skills

• Strong scientific writing and data interpretation
• Excellent cross-functional collaboration
• Strategic thinking and data-driven decision making
• Leadership and team coordination capabilities

Education

• As listed in qualifications (PhD/Pharm D, MS, or BA/BS with equivalent experience)

Additional Requirements

• Work Location: Hybrid role; on-site average 2.5 days/week within commuting distance