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

Pfizer • New York City, NY

16d • Hybrid

About The Position

Responsible for scientific oversight, data integrity, and quality of clinical trials supporting development strategies for programs in the Late-Stage Oncology portfolio. Serves as a clinical development expert for assigned studies, maintaining current scientific and clinical knowledge in the relevant therapeutic and disease areas. Partners with clinical and medical colleagues, Clinical Operations, and other functional teams to implement and execute trials. Represents study teams in governance meetings and submissions, and supports the Development Lead or Medical Director with study and disease-area strategy.

Authors protocols and study-level informed consent documents, and contributes to investigator brochures, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents. Supports preparation for Health Authority meetings and participates as appropriate. Establishes clinical data review strategy, leads teams in collecting quality data and reviewing emerging data and trends, and presents relevant findings to internal and external stakeholders. In partnership with medically qualified colleagues, analyzes emerging safety profiles and communicates changes to clinical and safety colleagues.

Follows applicable SOPs, regulations, and training requirements; seeks ways to improve the quality and efficiency of clinical procedures; and leads or participates in portfolio- and enterprise-level workgroups to optimize clinical development procedures. May serve as a subject matter expert or business process owner for a relevant SOP or procedure.

Requirements

• PhD or PharmD in a relevant science discipline and at least 2 years of Clinical Research experience in industry or a CRO; or an MS in a relevant science discipline and at least 5 years of such experience; or a BA/BS in a relevant science discipline and at least 7 years of such experience in a similar industry or CRO role.
• Experience in oncology clinical trial development.
• Solid tumor and/or hematologic oncology Clinical Research experience in Phase 3 or pivotal trials; sponsor-side experience and a record of successful regulatory submission, inspection, and approval are ideally sought.
• Excellent knowledge of clinical procedures, ICH guidelines, and GCP, and familiarity with FDA, EMA, and global regulations.
• Extensive understanding of related disciplines, including Clinical Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-clinical, Pharmacology, and Quality Assurance.
• Experience working with large data sets.
• Proficiency with Microsoft Office and relevant scientific software.
• Effective communication, presentation, and organizational skills to ensure coordinated and timely delivery.
• Experience using a variety of communication tools and techniques to communicate results.
• Experience solving problems collaboratively and handling conflict constructively.
• Track record of scientific productivity, evidenced by publications, posters, abstracts, and/or presentations.
• Ability to work proactively and independently and organize tasks, time, and priorities for oneself and others.
• Experience building partnerships across a company to meet program needs.
• Demonstrated ability to make complex decisions, exercise judgment, solve problems, and make decisions autonomously in clinical work.
• Ability to adapt to a changing work environment while maintaining integrity and quality.
• Ability to work effectively in diverse teams across cultures, backgrounds, and geographies, both as a leader and contributor.
• Breadth of leadership experience and capabilities, including influencing and collaborating with peers, developing and coaching others, and overseeing or guiding colleagues' work.
• Must be authorized to work in the United States for any employer; U.S. work visa sponsorship is unavailable.
• Requires permanent work authorization in the United States.

Nice To Haves

• Sponsor-side experience in Phase 3/pivotal oncology trials.
• A track record of successful regulatory submission, inspection, and regulatory approval.
• Experience leading or participating in portfolio- and enterprise-level workgroups to improve clinical development procedures.
• Experience as a subject matter expert or business process owner for an SOP or procedure.

Responsibilities

• Maintain current scientific and clinical knowledge in the therapeutic and disease areas relevant to assigned studies.
• Partner with clinical and medical colleagues, Clinical Operations, and other functional teams to implement and execute assigned clinical trials.
• Provide scientific oversight and ensure the data integrity and quality of clinical trials.
• Represent the study team in governance meetings and submissions, and support the Development Lead or Medical Director on study and disease-area strategy.
• Author protocols and study-level informed consent documents; contribute to 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, and present and discuss relevant data with teams, governance bodies, and internal and external stakeholders.
• Partner with medically qualified colleagues to analyze the emerging safety profile of the drug and keep clinical and safety colleagues informed of changes.
• Follow relevant SOPs and regulations and comply with applicable training requirements.
• Identify opportunities to improve the quality and efficiency of clinical procedures.
• Lead or participate in portfolio- and enterprise-level workgroups aimed at optimizing clinical development procedures.
• Potentially serve as a subject matter expert or business process owner for a relevant SOP or procedure.
• Collaborate across the company, influence peers, and guide or develop colleagues to achieve program outcomes.

Benefits

• 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
• Paid vacation, holidays, and personal days
• Paid caregiver, parental, and medical leave
• Medical, prescription drug, dental, and vision coverage
• Participation in Pfizer’s Global Performance Plan, with a bonus target of 17.5% of base salary
• Eligibility to participate in a share-based long-term incentive program
• Relocation assistance may be available based on business needs and/or eligibility

What This Job Offers

• Job Type: Full-time
• Career Level: Senior