Mgr Clinical Biomarkers & Diagnostics

Job Title: Mgr Clinical Biomarkers & Diagnostics
Location: Remote
Duration: 6 Months (Possibility of extension depending upon business requirements and performance)

Top 3 Must Have Skill Sets:

• Strong expertise in Obesity/CV/Met disease and biomarker research.
• Experience leading and integrating cross functional and technical teams.
• Experience overseeing vendors/CROs for biomarker assays and sample operations.

Description:

• Location: Remote - Flexible Time Zone
• Qualifications: PhD with a minimum of 3 years of experience.
• Ideally, Candidates will have 5-7 years of experience in obesity and/or cardiometabolic disease, clinical biomarker research, and drug development.

What you will do:

• Let's do this. Let's change the world through Precision Medicine!
• In this vital role within the Precision Medicine Unit, the Contract Clinical Biomarker Lead will serve as a key member of organization cross-functional product teams, driving biomarker strategies that align with Precision Medicine goals.
• 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. 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.

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.

Day to Day 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.

Possible Extension:
Yes

Red Flags:
N/A