Oncology Biomarker Operations Lead

Mykelly; Spring House (PA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical, Dental, Vision benefits

401(k)

Paid time off

Job summary

Kelly Science and Clinical FSP is seeking a Biomarker Operations Manager to lead the biomarker and diagnostic strategy for oncology clinical programs. The role spans early and late-stage trials with responsibility for sample collection, testing, and data delivery.

You will bridge science and operations, coordinating with vendors, centralized labs, and cross-functional teams globally to meet development timelines and specifications.

Qualifications

• Bachelor's degree in a scientific field required; advanced degrees desirable.
• 5+ years in clinical development or biomarker/diagnostics领域.
• Strong knowledge of ICH GCP, GLP, and clinical drug development processes.
• Excellent written and verbal communication; ability to work with global cross-functional teams.

Responsibilities

• Drives the biomarker and diagnostic strategy for early and late-stage oncology programs.
• Manages biomarker plans, timelines, budgets, risk assessments, and quality metrics.
• Coordinates with procurement and scientific leads for contracts and statements of work.
• Oversees central lab setup and management across studies.
• Maintains relationships with specialty testing vendors to ensure data delivery on time.
• Collaborates with data management to establish data transfer with labs and vendors.
• Contributes to clinical documents such as protocols and study reports.
• Identifies and implements innovative sample collection and processing techniques across sites.
• Develops biomarker plan presentations and tracks sample/testing metrics.

Skills

Cross-functional collaboration

Project management

Written and verbal communication

Biomarker/diagnostics knowledge

Global teamwork

Education

Bachelor’s degree in life sciences

MS/PhD in life sciences

Project management certification (e.g., PMP)

Job description

Kelly Science and Clinical FSP is seeking a Biomarker Operations Manager to lead the biomarker and diagnostic strategy for oncology clinical programs. The role spans early and late-stage trials with responsibility for sample collection, testing, and data delivery.

You will bridge science and operations, coordinating with vendors, centralized labs, and cross-functional teams globally to meet development timelines and specifications.