Biomarker Operations Lead – Oncology Programs

Kelly Science, Engineering, Technology & Telecom; Spring House (PA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401K

Paid time off

Job summary

Kelly Science and Clinical FSP is seeking a Biomarker Operations Manager to support our pharmaceutical partner. The role sits in the Oncology Biomarker & Diagnostic Operations team, implementing and executing clinical sample collection, testing, and data delivery for oncology programs.

The position is based in Spring House, PA or Cambridge, MA, and offers full benefits, including medical, dental, vision, 401K, and paid time off.

Qualifications

• Bachelor's degree in a scientific field; MS/PhD desirable.
• 5+ years in clinical development or biomarker/diagnostics.
• Knowledge of ICH GCP, GLP; clinical drug development planning.
• Excellent written and verbal communication; global cross-functional teamwork.

Responsibilities

• Drives the biomarker and diagnostic strategy for early and late-stage oncology programs.
• Develops biomarker and diagnostic plans, timelines, budgets, risk assessments, and quality metrics.
• Collaborates with procurement and scientific leads to finalize contracts and statements of work.
• Supports central lab setup and management across studies.
• Manages relationships with specialty testing vendors to meet timelines and specs.
• Coordinates data transfer processes with testing vendors and local labs.
• Prepares clinical documents such as protocols, study reports, and lab manuals.
• Identifies and implements innovative biomarker collection and processing methods.
• Presents biomarker plans, timelines, and metrics at team meetings.
• Evaluates new assays and technologies as required by programs.
• Manages relationships with internal and external partners to ensure timely deliverables.
• Participates in cross-functional study team meetings across clinical, translational research and diagnostics.

Skills

Cross-functional collaboration

Project management

Biomarker/diagnostics knowledge

Clinical development understanding

Written and verbal communication

Education

Bachelor's degree in life sciences

MS/PhD in a related field (desirable)

Project management certification (desirable)

Tools

Clinical trial management systems (CTMS)

Lab information management systems (LIMS)

Job description

Kelly Science and Clinical FSP is seeking a Biomarker Operations Manager to support our pharmaceutical partner. The role sits in the Oncology Biomarker & Diagnostic Operations team, implementing and executing clinical sample collection, testing, and data delivery for oncology programs.

The position is based in Spring House, PA or Cambridge, MA, and offers full benefits, including medical, dental, vision, 401K, and paid time off.