Precision Medicine Global Biomarker Lead

Amgen • Thousand Oaks, CA

1d

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Precision Medicine Global Biomarker Lead What you will do Let’s do this. Let’s change the world. In this vital role within the Precision Medicine Unit, the Clinical Biomarker Lead will serve as a key member of Amgen’s 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 in obesity and/or cardiometabolic diseases 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, discovery biomarker, and research colleagues. This role also includes authorship and review of essential clinical and regulatory documents to support decision-making across the portfolio.

Requirements

• Doctorate degree and 2 years of Biomarker Development experience OR Master’s degree and 4 years of Biomarker Development experience OR Bachelor’s degree and 6 years of Biomarker Development experience OR Associate’s degree and 10 years of Biomarker Development experience OR High school diploma / GED and 12 years of Biomarker Development experience

Nice To Haves

• PhD in a relevant field; PharmD, MD, or equivalent considered.
• Minimum 3+ years of relevant experience, ideally in industry.
• Strong expertise in obesity and/or cardiometabolic disease.
• Experience in assay validation/qualification and readiness
• Experience leading and integrating cross functional and technical teams.
• Proven track record in clinical biomarker research and drug development.
• Experience overseeing vendors/CROs for biomarker assays and sample operations.
• Demonstrated proficiency in solving complex problems and driving successful implementation of team objectives.
• Strong professional network (external KOLs, institutions, vendors, and partners)
• Experience with global programs and regulatory filings (IND/CTA/MAA/NDAs) is a plus.

Responsibilities

• Lead development and execution of comprehensive clinical biomarker strategies for pharmacodynamics, target engagement, and patient stratification for chronic weight management and cardiometabolic disease programs across the drug development pipeline from Phase 1 to Phase 3 trials.
• Collaborate cross-functionally with internal and external partners as the Clinical Biomarker Representative to enable biomarker strategy alignment and delivery of high-quality biomarker datasets.
• Present clinical biomarker strategies to senior leadership for program alignment and endorsement.
• Lead and partner with biomarker technical sub-teams to plan all components of clinical biomarker strategy implementation including specialty vendor evaluations, biomarker budget and contract planning, biomarker and pharmacodynamic sample operations, biomarker data analysis plans, and cross-functional data sharing.
• Translate discovery biomarkers into clinically validated assays by defining go/no-go criteria, designing pilot studies, and executing assay transfer/validation to ensure probability of success in trials.
• Develop and execute clinical proof of concept and pilot studies for biomarker hypothesis testing.
• Contribute to the drafting and review of clinical study documents, including study protocols, informed consent forms, clinical study reports, scientific reports, and manuscripts.
• Deliver presentations to internal scientific and governance forums, as well as at external scientific congresses.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees