Hybrid Senior Manager, Late-Stage Oncology Development

Pfizer

San Diego (CA)

Hybrid

USD 139,000 - 232,000

Full time

14 days+

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Job summary

Pfizer is seeking a Clinical Development expert to oversee scientific integrity and data quality for Late-Stage Oncology programs. The role collaborates with medical and clinical operations teams to drive trial execution, governance, and regulatory readiness across studies.

You will author essential documents, shape data review strategies, and monitor safety signals while aligning with global regulations and procedural standards.

Qualifications

  • PhD/Pharm D in a relevant Science discipline and minimum of 2 years Clinical Research experience in industry/CRO
  • MS in a relevant Science discipline and minimum of 5 years of Clinical Research experience in industry/CRO OR
  • BA/BS in a relevant Science discipline and minimum of 7 years Clinical Research experience in a similar role in industry/CRO
  • Experience in oncology clinical trial development, solid tumor and/or heme
  • 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.
  • 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.

Responsibilities

  • Clinical development expert for assigned studies maintaining current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment.
  • Partner with clinical operations and other functional lines for successful implementation and execution of trials.
  • Responsible for scientific oversight, data integrity and quality of the trials.
  • Represent study team in governance meetings and support study/disease area strategy.
  • Author protocols, informed consent documents, and contribute to IBs, site training materials, study reports, regulatory responses.
  • Set the clinical data review strategy and lead data quality reviews and trend analysis.
  • Analyze emerging safety profile and keep team informed of changes.
  • Follow SOPs and regulations; participate in portfolio- and enterprise-level workgroups.

Skills

Scientific oversight
Data integrity
Cross-functional collaboration
Communication
Leadership

Education

PhD/PharmD
MS in a relevant Science discipline
BA/BS in a relevant Science discipline

Tools

Microsoft Office
Scientific software

Job description

Pfizer is seeking a Clinical Development expert to oversee scientific integrity and data quality for Late-Stage Oncology programs. The role collaborates with medical and clinical operations teams to drive trial execution, governance, and regulatory readiness across studies.

You will author essential documents, shape data review strategies, and monitor safety signals while aligning with global regulations and procedural standards.

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