Oncology Late Stage Clinical Scientist; Senior Manager, Non MD

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

Location availability:

• Bothell, Washington
• Collegeville, Pennsylvania
• New York City, New York
• Cambridge, Massachusetts
• Groton, Connecticut

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.

To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.

Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life‑changing medicines to the world.

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

Position Summary: 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.

• Act as clinical development expert for assigned studies, maintaining current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment.
• Partner effectively 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.
• Provide scientific oversight, ensuring 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, and contribute to authoring of investigator brochures, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents; support preparation for Health Authority meetings and participate as appropriate.
• Set the clinical data review strategy and lead the team in collecting quality data and reviewing 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.
• Work in close partnership with medically qualified colleagues; analyze the emerging safety profile of the drug, keeping the clinical and safety colleagues informed of changes as they occur in the assigned trial(s).
• Follow relevant SOPs and regulations; understand applicable trainings; seek opportunities to improve quality and efficiency of clinical procedures; lead or actively participate in portfolio‑ and enterprise‑level work groups to optimize PFE clinical development procedures; may serve as subject‑matter expert or business process owner for a relevant SOP or procedure.

Minimum Qualifications:

• PhD/Pharm D in a relevant science discipline and ≥ 2 years clinical research experience in industry/CRO, or
• MS in a relevant science discipline and ≥ 5 years clinical research experience in industry/CRO, or
• BA/BS in a relevant science discipline and ≥ 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.
• Experience solving problems collaboratively and handling conflict constructively.
• Track record of scientific productivity as evidenced by publications, posters, abstracts,…