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Pfizer

Makes cancer drugs, vaccines and other medicines

Clinical Development Scientist - Multiple Teams

Clinical Research OperationsConfirmed live in the last 24 hours
Full-time

About the Job

Requirements

  • A PhD or PharmD and at least 5 years of relevant industry experience in clinical development, clinical research, or a related drug development role, with a demonstrated track record of supporting development programs through key milestones; or an MS and at least 7 years of relevant industry experience in those areas; or a BSc and at least 8 years of relevant industry experience in those areas.
  • Deep understanding of the biopharmaceutical environment and clinical drug development, with familiarity across related disciplines including Biostatistics, Regulatory Affairs, Clinical Pharmacology, and Pharmaceutical Sciences.
  • Experience developing and coaching others, guiding cross-functional teams, and driving meaningful business impact.
  • Strong scientific writing, presentation, and verbal communication skills.
  • Experience building consensus, influencing stakeholders, and driving change across all levels of the organization, including senior leadership.
  • Strong experience reviewing clinical data listings and interpreting study data.
  • Ability to perform complex data analysis.
  • Must be authorized to be employed in the United States by any employer and have permanent work authorization in the United States.

Responsibilities

  • Provide scientific leadership for the design, execution, and interpretation of clinical studies, delivering innovative study designs, high-quality trial execution, safety assessments, and clinically meaningful study outcomes.
  • Lead and support the development and execution of clinical development programs, operating independently within project teams.
  • Serve as a technical resource for clinical issues raised by internal and external collaborators, investigators, consultants, and contractors.
  • Support the development of publications, abstracts, presentations, and scientific communications.
  • Participate on project teams to support clinical development strategy, study implementation, and achievement of key development milestones, including the startup, conduct, and delivery of clinical studies.
  • Lead preparation of clinical protocols and lead or contribute to other key study documents, including informed consent forms, study training materials, investigator brochures, statistical analysis plans, and regulatory documents.
  • Lead clinical data review activities, including the collection, analysis, and interpretation of safety and efficacy data for safety review meetings and ongoing data review activities conducted in accordance with data review plans.
  • Collaborate with study teams to maintain open and transparent communication and support successful study execution and completion.
  • Foster partnerships across teams, sub-teams, and therapeutic areas.
  • Develop partnerships with project leaders and cross-functional colleagues across Pfizer, including Biostatistics, Regulatory Affairs, Clinical Pharmacology, Clinical Operations, and other relevant functions.
  • Be accountable to multiple project teams, core study teams, and clinical sub-teams while effectively managing priorities to support the startup, conduct, and closeout of clinical studies.
  • Develop expertise in Pfizer clinical processes, checklists, and Standard Operating Procedures to ensure compliance with Good Clinical Practice, regulatory requirements, Institutional Review Boards, and Pfizer standards; apply learnings to support continuous process improvement within the I&I organization.
  • Develop expertise in Pfizer compliance systems, registries (including GDMS, pTMF, and Clinical Trial Registries), and other study systems (including CORD, JReview, and Signal Management), and apply lessons learned to improve study execution across the I&I organization.
  • Partner with relevant functional lines to ensure biomarker strategies are incorporated into therapeutic area programs to support patient stratification, efficacy assessments, and clinical development objectives.
  • Establish and maintain relationships with external experts, consultants, key opinion leaders, regulators, and disease-specific investigator networks to incorporate evolving scientific and clinical insights into development plans and study designs and to support study conduct, data interpretation, and dissemination of results.
  • Maintain current knowledge of scientific and clinical literature relevant to I&I therapeutic areas and associated clinical development strategies.

Desired Qualifications

  • Experience in Immunology clinical development.
  • Experience supporting Phase 2, Phase 3, and/or late-stage clinical development programs.

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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