Director, Global Diagnostics Strategy Lead

About the role

Amgen is hiring a Director, Global Diagnostics Strategy Lead to lead the creation, alignment and execution of comprehensive global diagnostic strategies for assigned molecules and programs within a disease area or therapeutic area. The role is the primary diagnostic strategy point of contact for program teams and governance forums, ensuring diagnostic development plans support clinical development, regulatory approval, launch, commercialization and lifecycle management of precision therapeutics. The Diagnostics Group is responsible for bringing biomarker assays to marketed diagnostics.

Key responsibilities

• Develop and lead integrated, end-to-end diagnostic strategies from early need assessment through launch and lifecycle management.
• Partner with Product Teams and program leadership to align therapeutic and diagnostic development objectives.
• Evaluate and propose diagnostic options, including assay and platform approaches, partner strategy, regulatory and commercial pathways, costs, timelines and risks.
• Lead and oversee Dx Development Teams, and manage, coach and develop a small team of Dx technical leads.
• Represent the Dx function internally and with external diagnostic development partners, and select and oversee diagnostic development partners.
• Integrate diagnostic plans with therapeutic development and clinical trials, and partner with commercial teams on global launch, commercialization and lifecycle management.
• Communicate balanced, unbiased assessments of diagnostic opportunities and risks in a matrixed environment, and engage stakeholders such as Dx Regulatory, Clinical, Medical, Commercial, Value and Access, and Business Development.

Required profile

• Either a doctorate with 4 years of experience, a master's with 8 years, or a bachelor's with 10 years in pharmaceutical, biotechnology, diagnostics, clinical development or related fields.
• Preferred: direct experience developing diagnostic, companion diagnostic or precision medicine strategies, and an advanced degree in biomedical sciences, medicine, diagnostics, molecular biology, pathology, genomics or oncology.
• Preferred: documented experience with oncology precision medicine, IVD, companion diagnostics, biomarker assay development or diagnostic platform lifecycle management.

Required skills

• Knowledge of clinical, regulatory, commercial and access considerations shaping global diagnostic development and launch plans.
• Experience evaluating diagnostic technologies, development options, market landscapes and business cases, including trade-offs of cost, time, risk and opportunity.
• Ability to lead cross-functional teams and influence without direct authority.