Director, Global Diagnostics Strategy Lead

Job description

Career CategoryResearchJob DescriptionJoin Amgen’s Mission of Serving PatientsAt 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. Director, Global Diagnostics Strategy LeadWhat you will doIn this vital role, the Director, Global Diagnostic Strategy Lead (DxSL) will lead the creation, alignment, and execution of comprehensive global diagnostic strategies for assigned molecules and programs within a disease area or therapeutic area. The DxSL serves as the primary diagnostic strategy point of contact for program teams and governance forums, helping ensure that diagnostic development plans enable clinical development, regulatory approval, launch, commercialization, and lifecycle management of precision therapeutics. The Diagnostics (Dx) Group is responsible for the successful transition of biomarker assays into marketed diagnostics that support therapeutic development strategy, regulatory approval, access, and commercialization. You will: Develop and lead integrated, end-to-end diagnostic strategies from early diagnostic need assessment through launch and lifecycle management. Partner with Product Teams, program leadership and other decision-making forums, to align therapeutic and diagnostic development objectives. Evaluate and propose diagnostic strategic options, including assay and platform approaches, partner strategy, regulatory and commercial pathways, trade-offs, opportunities, costs, timelines, and risks. Lead and oversee Dx Development Teams (DxDTs) to ensure tactical execution of the diagnostic development plan and alignment between Rx and Dx development programs. Influence decision-making in a matrixed environment by communicating balanced, unbiased assessments of diagnostic opportunities and risks. Represent the Dx function with internal stakeholders and external diagnostic development partners. Manage, coach, and develop a small team of Dx technical leads, as applicable, while delivering through cross-functional leadership and influence. Key Responsibilities Diagnostic strategy and portfolio leadership Assess the need for diagnostic development for each assigned molecule or program within the disease area or therapeutic area portfolio. Work with cross-functional Dx subject matter experts and program functional leads to build comprehensive, global, long-term diagnostic strategies that support program objectives. Document and communicate diagnostic strategy through appropriate templates, decision materials, and executive-ready slide decks. Provide strategic input to program teams and governance forums to enable informed decisions on diagnostic development options. Execution through Dx Development Teams Oversee DxDTs to ensure delivery of diagnostic development plans, milestones, timelines, risks, mitigations, and interdependencies. Partner with Project Management to track risks, mitigations, milestones, timelines, resources, and financials across diagnostic development activities. Ensure diagnostic strategies and plans are integrated with therapeutic development plans and clinical trial execution needs. Operate within Amgen governance, policy, and decision-making frameworks, including DAI where applicable. External partner strategy and business planning Work across Amgen functions to identify, evaluate, and select diagnostic development partners as needed. Oversee partner-selection activities related to diagnostic development, including workplan development and alignment on scope, roles, and deliverables. Lead collaboration with external diagnostic partners to integrate diagnostic development, approval, and launch strategies. Global launch, commercialization, and lifecycle management Ensure diagnostic strategies incorporate global clinical, regulatory, commercial, access, and regional execution requirements. Partner with global and regional commercial teams to align on commercial diagnostic strategy, including regional or country gap assessments. Lead lifecycle management planning for diagnostic platforms or assays to support program objectives after initial approval and launch. Support diagnostic market landscape assessments and business case development for key strategic choices. Matrix leadership and stakeholder engagement Communicate effectively with Amgen leadership, therapeutic product teams, cross-functional collaborators, and external partners. Lead with courage and influence without direct authority across a complex matrix environment. Proactively provide balanced and thoughtful input to product teams and other work package teams. Actively seek and incorporate input from Dx Regulatory, Drug Regulatory, Clinical, Medical, Commercial, Value and Access, Business Development, Alliance Management, and other stakeholders. Core Deliverables Comprehensive diagnostic development strategies for assigned drug development programs and portfolio priorities. Documented Dx strategy materials, including strategy templates, decision documents, and slide decks for cross-functional alignment and governance discussions. Aligned Rx/Dx development plans with clear milestones, risks, mitigations, timelines, and accountabilities. Diagnostic partner selection recommendations and workplans, where partner support is needed. Global and regional diagnostic launch, commercialization, and lifecycle management plans. Dx representation and strategic input at Product Team, EGT, CBDT, DxLT and other relevant forums. Basic Qualifications Doctorate degree and 4 years of pharmaceutical, biotechnology, diagnostics, clinical development, or related experience; OR Master's degree and 8 years of pharmaceutical, biotechnology, diagnostics, clinical development, or related experience; OR Bachelor's degree and 10 years of pharmaceutical, biotechnology, diagnostics, clinical development, or related experience; AND Preferred Qualifications Direct experience developing and implementing diagnostic, companion diagnostic, or precision medicine strategies within a pharmaceutical, biotechnology, or diagnostics setting. Advanced degree in biomedical sciences, medicine, diagnostics, molecular biology, pathology, genomics, oncology, or related discipline (Ph.D., M.D., Pharm.D., or equivalent). Strong scientific acumen paired with a strategic mindset and the ability to translate biomarker and diagnostic insights into development and commercialization strategies. Knowledge of the clinical, regulatory, commercial, and access considerations that shape global diagnostic development and launch plans. Documented experience with oncology precision medicine, in vitro diagnostics (IVD), companion diagnostics (CDx), biomarker assay development, or diagnostic platform lifecycle management. Experience evaluating diagnostic technologies, development options, market landscapes, and business cases, including trade-offs related to cost, time, risk, opportunity, and global execution. Demonstrated ability to lead cross-functional teams, influence without authority, and gain alignment across senior stake