Remote Senior Scientist, Biomarker Development

Kelly; Charlotte (NC); Remote; USD 130,000 - 170,000; Full time

Job summary

Kelly Science & Clinical seeks a Senior Scientist – Biomarker Development to lead biomarker assay design and qualification from research to early clinical development for a client in San Diego, CA. The role involves managing CRO partnerships, coordinating sample logistics, and contributing to regulatory artifacts.

The candidate should have MS with 6+ years or PhD with 3+ years in biomarker or molecular biology, with hands-on ELISA and MSD experience and strong scientific writing abilities.

Qualifications

• MS with 6+ years or PhD with 3+ years in a lab setting.
• Hands-on experience developing and qualifying ligand-binding assays incl. ELISA/MSD.
• Experience overseeing in vitro/in vivo assay design for gene therapy, small molecules, or proteins.
• Experience taking assays from development to qualification for clinical testing.
• Direct or CRO management of sample testing procedures.
• Experience contributing biomarker content to regulatory submissions preferred.
• Proven documentation in ELN or lab notebooks and strong scientific writing.

Responsibilities

• Design, develop, and qualify biomarker assays for proteins and pharmacodynamic markers.
• Oversee clinical biomarker testing at CRO partners and manage sample logistics.
• Define sample collection, processing, and storage requirements.
• Provide biomarker input to program decisions and regulatory documents.
• Maintain detailed experimental records and SOPs.
• Evaluate new biomarker technologies to address development questions.

Skills

Molecular biology experience

ELISA

MSD electrochemiluminescence

CRO management

In vitro/in vivo assay design

Regulatory submissions awareness

Scientific writing

Problem solving

Education

MS degree

PhD degree

Tools

ELISA platforms

MSD platforms

Job description

Kelly Science & Clinical seeks a Senior Scientist – Biomarker Development to lead biomarker assay design and qualification from research to early clinical development for a client in San Diego, CA. The role involves managing CRO partnerships, coordinating sample logistics, and contributing to regulatory artifacts.

The candidate should have MS with 6+ years or PhD with 3+ years in biomarker or molecular biology, with hands-on ELISA and MSD experience and strong scientific writing abilities.