Precision Medicine Global Biomarker Lead , Rare Disease

Precision Medicine Global Biomarker Lead - Rare Disease

Let’s do this. Let’s change the world. In this vital role within the Precision Medicine Unit, the Global Biomarker lead will serve as a key member of Amgen’s cross-functional product teams, driving biomarker strategies that align with Precision Medicine goals.

• Develop and execute scientifically robust precision medicine strategies that are integrated with global development strategies
• Oversee assay readiness, vendor management, and interpretation of biomarker data generation
• Partner closely with clinical development, research, and medical affairs colleagues
• Lead and partner with biomarker technical sub-teams to plan all components of clinical biomarker strategy implementation
• Interpret and communicate key clinical biomarker findings in an impactful way to cross functional and non-technical stakeholders
• Establish and implement biomarker studies and collaborations with academic laboratories/KOLs

Key Responsibilities

• Lead the development and execution of robust program-specific clinical biomarker strategies to inform target engagement, pharmacodynamics, mechanism of action, and patient selection across early and late stage programs
• Serve as precision medicine subject matter expert within product evidence generation teams to deliver precision medicine and translational medicine approaches to enable strategic alignment and delivery of high-quality biomarker datasets
• Responsible for biomarker elements in clinical protocols, biomarker analysis plans, regulatory submissions, investigator meetings, advisory boards and publications
• 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
• Interpret and communicate key clinical biomarker findings in an impactful way to cross functional and non-technical stakeholders, including Precision Medicine teams, product teams, R&D leadership, external scientific congresses, and lay audiences

Basic Qualifications

• Doctorate degree in a bioscience or medical discipline and 3+ years of industry experience
• Or Master’s degree in a bioscience or medical discipline and 6+ years of industry experience
• Or Bachelor’s degree in a bioscience or medical discipline and 8+ years of industry experience

Preferred Qualifications

• PhD in a relevant field; PharmD, MD, or equivalent considered
• Minimum 5+ years of relevant experience, ideally in industry
• Experience in developing program-based clinical biomarker strategies and its execution while supporting cross-functional clinical study teams
• Strong expertise in rare disease, autoimmunity, inflammation, cell biology, and genomics
• Strong written and verbal communication skills with experience drafting technical reports, clinical documents, and biomarker publications, and interpreting and communicating biomarker results to cross-functional teams and R&D leadership
• Experience implementing a broad array of biomarker platforms and technologies including biomarker assay development and qualification, analysis of clinical samples, and managing biomarker assay outsourcing processes with external vendors and CROs for clinical stage programs
• Experience in managing direct and dotted line reports, as well as matrix management of staff through team leadership
• Experience working effectively in a globally dispersed team environment with cross-cultural partners
• Experience with global programs and regulatory filings (IND/CTA/NDAs) is a plus