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