Clinical Research Scientist

You will be 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.

Key Responsibilities

• Provide clinical development expertise 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 clinical trials.
• Ensure scientific oversight, data integrity and quality of clinical trials.
• Represent the study team in governance meetings and submissions, and 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.
• Set the clinical data review strategy and lead the team in collecting quality data and reviewing emerging clinical data and trends.
• Analyze the emerging safety profile of the drug, keeping clinical and safety colleagues informed of changes in the safety profile.
• Follow relevant SOPs and regulations, and seek opportunities to improve quality and efficiency of clinical procedures.

Minimum Qualifications

• PhD/Pharm D in a relevant Science discipline and minimum of 5 years Clinical Research experience in industry/CRO, OR
• MS in a relevant Science discipline and minimum of 7 years of Clinical Research experience in industry/CRO OR
• BA/BS in a relevant Science discipline and minimum of 10 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 side of the sponsor and with a track record of successful regulatory submission, inspection, and regulatory approval
• Solid tumor or hematology clinical trial experience
• Experience leading a team
• 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

Competencies for Success

• Demonstrates passion for helping patients with cancer and for the science of oncology
• Flexibility to adapt and navigate through an ever-changing work environment while maintaining integrity and quality in the work assigned
• Demonstrates autonomous delivery, problem-solving, and agile decision-making in execution of Clinical responsibilities
• Promotes team health and exemplifies Pfizer’s leadership behaviors and actionable attitudes
• Leverages knowledge and support from others related to overall objectives, strategy, critical issues, and policies
• Demonstrates foresight and judgment to make complex decisions
• Promotes innovation and takes appropriate risks to challenge the status quo in order to enhance the efficiency of current processes
• Embraces evolving technologies and adopts best practices aimed at improving the efficiency and quality of clinical development
• Has a global perspective and mindset. Works well in a diverse team environment with colleagues from diverse cultures, backgrounds, and geographies. both as a leader and a key contributor

Work Location Assignment: This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week.

The annual base salary for this position ranges from $176,600.00 to $294,300.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program.