Mgr Clinical Biomarkers & Diagnostics

Location:Remote - Aliquippa, PA (Flexible Time Zone preferred)

Employment Type: Contingent Worker (Contract, W2)

Contract Length: 6 months (possible extension)

Compensation: Open Market Rate (based on experience)

Summary of the Role

Join a leading Precision Medicine Unit at a big biopharma leader as a Contract Clinical Biomarker Lead. In this strategic role, you will guide biomarker strategies for obesity and cardiometabolic programs and directly contribute to clinical and regulatory decision-making. The position requires scientific leadership, hands-on expertise in clinical biomarker research, and collaboration across global, cross-functional teams.

Key Responsibilities

• Develop and implement comprehensive clinical biomarker strategies for pharmacodynamics, target engagement, efficacy, and patient stratification.
• Serve as an independent scientific contributor supporting cross-functional product teams.
• Oversee readiness of biomarker assays and manage relationships with specialty vendors and CROs.
• Drive execution and delivery of biomarker data to support clinical development goals.
• Collaborate with clinical development, operations, discovery research, and computational biology colleagues.
• Create and review clinical and regulatory documents including study protocols, consent forms, clinical study reports, and manuscripts.
• Lead technical and operational biomarker sub-teams through planning and operational execution.
• Apply expertise to resolve scientific and operational challenges independently.

Required Experience & Skills

• PhD in a relevant field (PharmD, MD, or equivalent may be considered).
• Minimum 3+ years of relevant experience, ideally within the industry.
• Strong expertise in obesity and/or cardiometabolic disease.
• Demonstrated experience in clinical biomarker research and drug development.
• Experience collaborating in cross-functional, fast-paced environments.
• Track record of independent scientific contribution to complex projects.

Preferred Qualifications

• 5–7 years of experience in clinical biomarker research, with focus on obesity/cardiometabolic disease and drug development.

Top 3 Must Have Skills

1. Strong expertise in obesity/cardiometabolic disease and biomarker research.

2. Experience leading and integrating cross-functional and technical teams.

3. Experience overseeing vendors/CROs for biomarker assays and sample operations.

Day-to-Day Responsibilities

• Lead development and execution of biomarker strategies for cardiovascular disease programs spanning Phase 1 to Phase 3 clinical trials.
• Collaborate with internal and external partners to align biomarker strategy and deliver high-quality datasets.
• Manage biomarker technical and operations sub-teams, coordinating vendor selection, budget, planning, sample operations, and data analysis.
• Contribute to the drafting and review of clinical study documents and scientific reports.

Basic Qualifications

• PhD in a relevant field required; PharmD, MD, or equivalent considered. Minimum 3+ years of relevant experience, ideally in industry.

This posting is for Contingent Worker, not an FTE