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Pfizer

Makes cancer drugs, vaccines and other medicines

Oncology Late Stage Clinical Development Scientist – Senior Manager

Clinical Research OperationsConfirmed live in the last 24 hours
Full-time$139.1k - $231.9k /yr

About the Job

Requirements

  • A PhD or PharmD in a relevant science discipline and at least 2 years of clinical research experience in industry or a contract research organization; or an MS in a relevant science discipline and at least 5 years of clinical research experience in industry or a contract research organization; or a BA/BS in a relevant science discipline and at least 7 years of clinical research experience in a similar industry or contract research organization role.
  • Experience in oncology clinical trial development, including solid tumors and/or hematologic malignancies.
  • Clinical research experience in Phase 3 or pivotal oncology trials, ideally on the sponsor side, with a track record of successful regulatory submission, inspection, and approval.
  • Excellent knowledge of clinical procedures, International Council for Harmonisation guidelines, Good Clinical Practice, and familiarity with Food and Drug Administration, European Medicines Agency, 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.
  • A track record of scientific productivity demonstrated through publications, posters, abstracts, and/or presentations.
  • Experience working proactively and independently while organizing tasks, time, and priorities for self and others.
  • Experience building partnerships across the company to meet program needs.
  • Ability to influence and collaborate with peers, develop and coach others, and oversee and guide colleagues’ work to achieve meaningful outcomes and business impact.
  • Must be authorized to work in the United States by any employer and maintain permanent work authorization in the United States.

Responsibilities

  • Provide scientific oversight, data integrity, and quality oversight for clinical trials supporting development strategies for programs in the Late-Stage Oncology portfolio.
  • Serve as the clinical development expert for assigned studies and maintain current scientific and clinical knowledge in assigned therapeutic and disease areas.
  • Partner with clinical and medical colleagues, clinical operations, and other functional lines to implement and execute clinical trials within assigned programs.
  • Represent the study team in governance meetings and submissions, and partner with or support the Development Lead or Medical Director on study and disease-area strategy.
  • Author protocols and study-level informed consent documents; contribute to authoring 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 with appropriate teams, governance bodies, and internal and external stakeholders.
  • In close partnership with medically qualified colleagues, analyze the emerging safety profile of the drug and keep clinical and safety colleagues informed of changes in the safety profile during assigned trials.
  • Follow relevant standard operating procedures and regulations, comply with applicable training, and seek opportunities to improve the quality and efficiency of clinical procedures.
  • Lead or actively participate in portfolio- and enterprise-level workgroups aimed at optimizing clinical development procedures; may serve as a subject matter expert or business process owner for a relevant standard operating procedure or procedure.

Desired Qualifications

  • Experience in Phase 3 or pivotal oncology clinical research on the sponsor side, with a track record of successful regulatory submission, inspection, and approval.

About the Company

Pfizer

Makes cancer drugs, vaccines and other medicines

Pfizer discovers, makes, and sells prescription medicines and vaccines for patients, doctors, and governments worldwide, with large businesses in vaccines, cancer, heart disease, and rare diseases. In 2020, its COVID-19 shot, developed with German partner BioNTech, became the first COVID-19 vaccine authorized in the United States. Its scientists find drug candidates and run clinical trials to prove they are safe and effective, and Pfizer then manufactures approved products in its own plants, earning most of its money from patented drugs before cheaper generic copies arrive. Pfizer was founded in 1849 as a chemicals business in Brooklyn and is based in New York City.

Company size
10,001+
Company stage
IPO
Headquarters
New York City, New York
Founded
1849

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