Biomarker Study Program Lead

pfm; Houston (TX); On-site; USD 120,000 - 180,000; Full time

Job summary

PfM Specialty Lab is seeking a Principal Study Manager to lead cross-functional teams in biomarker assay analysis across GLP/GCLP and CAP/CLIA regulated studies. You will drive study milestones, budgets, and quality, while coordinating with external partners to ensure timely delivery.

The role requires extensive leadership, strong regulatory knowledge, and experience overseeing molecular and tissue-based biomarker work in a regulated setting.

Qualifications

• Bachelor's degree in life sciences or related field with significant experience in laboratory management.
• Advanced degree preferred with focus on biomarker assays, GLP/GCP experience is advantageous.
• Demonstrated ability to manage multiple studies with budgets and timelines.

Responsibilities

• Lead and direct scientific work for analysis of biomarker assays across GLP/GCLP and CAP/CLIA regulated studies.
• Direct delivery of study milestones within cost, time and quality constraints.
• Mentor junior Study Managers and ensure proper documentation and communication with clients.

Skills

Study management

Regulatory compliance

Budgeting

Cross-functional leadership

GCP/GLP knowledge

Education

Bachelor's degree in life sciences

Master's degree in life sciences

Tools

Laboratory Information Systems

Job description

PfM Specialty Lab is seeking a Principal Study Manager to lead cross-functional teams in biomarker assay analysis across GLP/GCLP and CAP/CLIA regulated studies. You will drive study milestones, budgets, and quality, while coordinating with external partners to ensure timely delivery.

The role requires extensive leadership, strong regulatory knowledge, and experience overseeing molecular and tissue-based biomarker work in a regulated setting.