Principal Scientist​/Clinical Biomarker Lead

Principal Scientist/Clinical Biomarker Lead

We are seeking a highly motivated scientist with expertise in clinical biomarker research and drug development within the Obesity/Cardiometabolic space to develop and execute biomarker plans that measure pharmacodynamics, target engagement, efficacy, and patient stratification. The successful candidate will oversee assay readiness, vendor management, and biomarker data generation, while partnering closely with clinical development, clinical operations, discovery biomarker, computational biology and research colleagues.

This role also includes authorship and review of essential clinical and regulatory documents to support decision-making across the portfolio.

Qualifications &

Experience:

• PhD in a relevant field required;
  PharmD, MD, or equivalent considered.
• Ideally, candidates will have 5–7 years of experience in obesity and/or cardiometabolic disease, clinical biomarker research, and drug development.
• Strong expertise in obesity and/or cardiometabolic disease.
• Proven track record in clinical biomarker research and drug development.

Responsibilities:

• 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.