Hybrid Senior Manager, Oncology – Late Stage

at Pfizer

• Job title: Senior Manager, Oncology – Late Stage
• Job type: Full Time
• Experience level: Senior
• Salary: Not specified
• Degree requirement: Postgraduate Degree
• Tech skills: Google Cloud Platform
• Location requirements: Hybrid, Cambridge, United Kingdom

About the role

• Senior Manager for Oncology at Pfizer, responsible for scientific oversight of late-stage clinical trials. Collaborating with cross-functional teams to ensure quality and regulatory compliance.

Responsibilities

• 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.
• 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 the successful implementation and execution of the clinical trial(s) within the assigned program.
• Represents the study team in governance meetings and submissions, partners with/supports the Development lead/Medical Director regarding study and disease area strategy.
• Authors protocols, study level informed consent documents, and contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents; supports preparations for Health Authority meetings, participates as appropriate.
• Sets the clinical data review strategy and leads the team in the collection of quality data and review of emerging clinical data and trends; reviews and queries data; presents and discusses relevant data to appropriate teams, governance bodies, and other internal and external stakeholders.
• In close partnership with medically qualified colleague/s, analyzes 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).

Requirements

• PhD/Pharm D in a relevant Science discipline and some Clinical Research experience in industry/CRO, OR MS in a relevant Science discipline and Clinical Research experience in industry/CRO, OR BA/BS in a relevant Science discipline and strong Clinical Research experience in a similar role in industry/CRO
• Clinical Research experience in the phase 3/pivotal space in Oncology, ideally on the side of the sponsor and 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, e.g., 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 and techniques to communicate results
• Experience solving problems collaboratively and handling conflict constructively.
• Track record of scientific productivity as evidenced by publications, posters, abstracts and/or presentations.
• Experience working proactively and independently, organizing tasks, time and priorities of self and others.
• Experience building partnerships across the company to achieve the needs of the program.

Benefits

• Health insurance
• Retirement plans
• Flexible working arrangements
• Professional development