Mgr Clinical Biomarkers & Diagnostics - Principal Scientist, Biomarkers #26-14437

About the role

The Contract Clinical Biomarker Lead will serve as a key member of Company’s cross-functional product teams, driving biomarker strategies that align with Precision Medicine goals.

Responsibilities

• Serve as an independent scientific contributor on projects/programs.
• Apply expertise to solve complex problems and drive successful implementation of team objectives.
• Partner effectively with team members and cross-functional colleagues in a fast-paced, collaborative environment.
• Lead development and execution of comprehensive clinical biomarker strategies for pharmacodynamics, target engagement, and patient stratification for cardiovascular disease programs across the drug development pipeline from Phase 1 to Phase 3 trials.
• Collaborate cross-functionally with internal and external partners to enable biomarker strategy alignment and delivery of high-quality biomarker datasets.
• Lead and partner with biomarker technical & operation sub-teams for clinical biomarker strategy implementation including specialty vendor evaluations, biomarker budget and contract planning, biomarker sample operations, biomarker data analysis plans, and cross-functional data sharing.
• Contribute to the drafting and review of clinical study documents, including study protocols, informed consent forms, clinical study reports, scientific reports, and manuscripts.

Qualifications & Experience

• PhD in a relevant field preferred; PharmD, MD, or equivalent considered.
• Minimum 3+ years of relevant experience, ideally in industry.
• Strong expertise in obesity and/or cardiometabolic disease.
• Proven track record in clinical biomarker research and drug development.