Oncology Late Stage Clinical Development Scientist (Non MD)--Multiple Openings- Director

Pfizer • New York City, NY

15h • Hybrid

About The Position

The Oncology Late Stage Clinical Development Scientist provides scientific oversight, data integrity, and quality oversight for clinical trials supporting development strategies within the Late-Stage Oncology portfolio. The role serves as a clinical development expert for assigned studies and maintains current scientific and clinical knowledge in the relevant therapeutic and disease areas.

The scientist partners with clinical and medical colleagues, Clinical Operations, and other functions to implement and execute trials. The role represents study teams in governance meetings and submissions and supports the Development Lead or Medical Director on study and disease-area strategy. Responsibilities include authoring protocols and study-level informed consent documents; contributing to investigator brochures, training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents; and supporting Health Authority meeting preparation and participation.

The role sets clinical data review strategy, leads collection and review of quality data and emerging trends, and presents relevant findings to internal and external stakeholders. In partnership with medically qualified colleagues, the scientist analyzes emerging drug safety profiles and keeps clinical and safety colleagues informed. The position follows applicable SOPs, regulations, training, and quality standards, and may lead or participate in portfolio- and enterprise-level efforts to improve clinical development procedures. This is a hybrid role requiring residence within commuting distance and an average of 2.5 on-site days per week.

Requirements

• PhD or PharmD in a relevant science discipline and at least 5 years of Clinical Research experience in industry or a CRO; or an MS in a relevant science discipline and at least 7 years of such experience; or a BA/BS in a relevant science discipline and at least 10 years of such experience in a similar industry/CRO role.
• Clinical Research experience in Phase 3 or pivotal oncology trials.
• Experience in solid tumor or hematology clinical trials.
• Experience leading a team.
• Extensive knowledge of clinical procedures, ICH guidelines, and GCP, and familiarity with FDA, EMA, and global regulations.
• 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 support coordinated and timely delivery.
• Experience using a variety of communication tools and techniques to communicate results.
• Collaborative problem-solving skills and ability to handle conflict constructively.
• Experience working proactively and independently, organizing tasks, and managing personal and team time and priorities.
• Experience building partnerships across a company to meet program needs.
• Ability to adapt to a changing work environment while maintaining integrity and quality; demonstrate autonomous delivery, problem-solving, agile decision-making, sound judgment, and appropriate risk-taking.
• Ability to work effectively in diverse teams across cultures, backgrounds, and geographies, both as a leader and contributor.
• Must be authorized to work in the United States by any employer and have permanent U.S. work authorization; work visa sponsorship is not available.

Nice To Haves

• Phase 3 or pivotal oncology clinical trial experience on the sponsor side.
• A track record of successful regulatory submission, inspection, and regulatory approval.
• Track record of scientific productivity demonstrated through publications, posters, abstracts, and/or presentations.
• Experience embracing evolving technologies and adopting practices that improve clinical development efficiency and quality.

Responsibilities

• Maintain current scientific and clinical knowledge in the assigned therapeutic and disease areas and provide clinical development expertise for assigned studies.
• Partner with clinical and medical colleagues, Clinical Operations, and other functional teams to implement and execute clinical trials.
• Provide scientific oversight and ensure the integrity and quality of clinical trial data.
• 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, and 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 clinical data review strategy; lead collection of quality data and review emerging clinical data and trends; review and query data; and present relevant findings to teams, governance bodies, and other stakeholders.
• Work with medically qualified colleagues to analyze the emerging safety profile of the drug and communicate safety-profile changes to clinical and safety colleagues.
• Follow applicable SOPs, regulations, and training requirements, and seek ways to improve the quality and efficiency of clinical procedures.
• Lead or actively participate in portfolio- and enterprise-level workgroups to optimize clinical development procedures; potentially serve as a subject matter expert or business process owner for an SOP or procedure.
• Promote team health and Pfizer leadership behaviors; influence and collaborate with peers, develop and coach others, and guide colleagues toward meaningful 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
• Eligibility to participate in Pfizer’s Global Performance Plan, with a 20% bonus target
• 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: Director