Precision Medicine Global Biomarker Lead
Amgen
10 hours ago
Remote friendly (United States)
United States
Clinical Research and Development
Precision Medicine Global Biomarker Lead
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 Phase 1 to Phase 3.
- Collaborate cross-functionally with internal and external partners as the Clinical Biomarker Representative to align biomarker strategy and deliver 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 implement biomarker strategy (specialty vendor evaluations, biomarker budget and contract planning, biomarker/pharmacodynamic sample operations, 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 for trial success.
- Develop and execute clinical proof of concept and pilot studies for biomarker hypothesis testing.
- Draft and review clinical study documents (protocols, informed consent forms, clinical study reports, scientific reports, manuscripts).
- Deliver presentations to internal scientific/governance forums and external scientific congresses.
Basic Qualifications:
- 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
Preferred Qualifications:
- PhD (PharmD/MD or equivalent considered); 3+ years relevant experience (ideally 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 problem-solving and successful team objective execution.
- Strong professional network (KOLs, institutions, vendors, partners).
- Experience with global programs and regulatory filings (IND/CTA/MAA/NDAs) is a plus.
Benefits (as listed):
- Retirement and Savings Plan (company contributions), group medical/dental/vision, life/disability insurance, flexible spending accounts.
- Discretionary annual bonus (or sales-based incentive for field sales roles).
- Stock-based long-term incentives.
- Award-winning time-off plans.
- Flexible work models where possible (per job’s Work Location Type).
Application Instructions:
- Apply now via careers.amgen.com.
- No application deadline; applications accepted until sufficient number or candidate selection.
- Sponsorship for this role is not guaranteed.
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 Phase 1 to Phase 3.
- Collaborate cross-functionally with internal and external partners as the Clinical Biomarker Representative to align biomarker strategy and deliver 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 implement biomarker strategy (specialty vendor evaluations, biomarker budget and contract planning, biomarker/pharmacodynamic sample operations, 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 for trial success.
- Develop and execute clinical proof of concept and pilot studies for biomarker hypothesis testing.
- Draft and review clinical study documents (protocols, informed consent forms, clinical study reports, scientific reports, manuscripts).
- Deliver presentations to internal scientific/governance forums and external scientific congresses.
Basic Qualifications:
- 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
Preferred Qualifications:
- PhD (PharmD/MD or equivalent considered); 3+ years relevant experience (ideally 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 problem-solving and successful team objective execution.
- Strong professional network (KOLs, institutions, vendors, partners).
- Experience with global programs and regulatory filings (IND/CTA/MAA/NDAs) is a plus.
Benefits (as listed):
- Retirement and Savings Plan (company contributions), group medical/dental/vision, life/disability insurance, flexible spending accounts.
- Discretionary annual bonus (or sales-based incentive for field sales roles).
- Stock-based long-term incentives.
- Award-winning time-off plans.
- Flexible work models where possible (per job’s Work Location Type).
Application Instructions:
- Apply now via careers.amgen.com.
- No application deadline; applications accepted until sufficient number or candidate selection.
- Sponsorship for this role is not guaranteed.