Director, Global Diagnostics Strategy Lead

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds 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 youll 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 youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

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 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
• Masters degree and 8 years of pharmaceutical biotechnology diagnostics clinical development or related experience; OR
• Bachelors 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 stakeholders in a matrix environment.
• Experience working with external diagnostic partners business development alliance management and/or partner governance structures.
• Familiarity with global regulatory submission requirements and diagnostic evidence expectations across major markets.
• Experience with clinical trial design biomarker-driven enrollment or testing strategies and integration of diagnostic requirements into therapeutic development plans.
• Excellent executive-level communication presentation facilitation and decision-framing skills.
• Strong project leadership skills including resource planning timeline management risk identification risk mitigation and financial awareness.
• Learning agility organizational savvy self-awareness adaptability in changing environments and an organized work style.

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 well 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:

• A comprehensive employee benefits package including a Retirement and Savings Plan with generous company contributions group medical dental and vision coverage life and disability insurance and flexible spending accounts
• A discretionary annual bonus program or for field sales representatives a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

In any materials you submit you may redact or remove age-identifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Amgen anticipates accepting applications until 1-2 weeks after the job posting; however we may continue accepting applications beyond this date if we do not receive a sufficient number of candidates.

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world Amgen fosters an inclusive environment of diverse ethical committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability status or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range