Director, Global Diagnostic Strategy Lead (DxSL)

Career Category

Research

Job Description

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.

Director, Global Diagnostic Strategy Lead (DxSL)

Live

What you will do

Let's do this. Let's change the world.

In 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 DxSL leads through a matrix of scientific, clinical, regulatory, operational, quality, and external partner teams, with accountability for a coherent development path from early feasibility through validation, regulatory review, and post-approval lifecycle activities.

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 team of Dx technical leads while delivering through cross-functional leadership and influence.

Key Responsibilities

Diagnostic Strategy Development

·         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

·         Compare technical options and development paths using scientific validity, feasibility, analytical and clinical performance, sample availability, turnaround time, scalability, and global implementation needs.

·         Identify key assumptions, evidence gaps, technical risks, and decision points; propose experiments or analyses to resolve them.

·         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.

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

·   Program-specific diagnostic strategies and target product profiles grounded in biomarker biology and intended clinical use.

·   Fit-for-purpose assay development, analytical validation, and clinical evidence plans with defined acceptance criteria and decision points.

·   Integrated diagnostic and therapeutic development plans, including trial testing strategy, sample and data flows, milestones, risks, and accountabilities.

·   Technical recommendations on assay selection, platform suitability, laboratory and partner capabilities, and bridging or comparability requirements.

·   Regulatory strategy and submission-ready diagnostic evidence packages, as appropriate to the program and region.

·      Operationally ready clinical study testing and post-approval plans for assay changes and lifecycle needs

Win

What we expect of you

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

In addition to meeting at least one of the above requirements, you must have at least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications

·         Advanced degree (PhD, MD, MD/PhD, PharmD, or equivalent) in molecular biology, pathology, translational medicine, oncology, biomedical engineering, diagnostics, or a related scientific discipline.

·         12 or more years of experience in companion diagnostics, in vitro diagnostic development, biomarker strategy, or translational medicine, with progressive technical or people leadership.

·         Demonstrated leadership of diagnostic or biomarker-enabled assay development through clinical development and regulatory review, including experience supporting therapeutic approval.

·         Previous diagnostic development experience within a pharmaceutical or biotechnology company is strongly preferred.

·         Deep knowledge of assay development and validation, including analytical performance, clinical performance, clinical utility, and interpretation of assay limitations.

·         Working knowledge of global diagnostic regulatory pathways, including FDA CDRH submissions, EU IVDR, PMDA, CMDE, performance studies, labeling, and post-approval obligations.

·         Experience with biomarker-driven clinical trial design, patient selection or stratification, central laboratory testing, sample management, and integration of diagnostic requirements into clinical protocols.

·         Experience directing external diagnostic laboratories, IVD sponsors, CROs, or technology vendors in complex, time-sensitive development programs.

·         Ability to assess diagnostic platforms and emerging technologies and translate their capabilities and limitations into practical development plans.

·         Proven ability to lead teams, mentor talent, manage priorities, and influence cross-functional decisions through sound scientific judgment and clear communication.

·         Ability to distill complex scientific, clinical, technical, regulatory, and operational information; identify the issues most relevant to a decision; and develop clear strategic recommendations and development paths.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date o