Biospecimen Strategy Lead - Oncology

Biospecimen Strategy Lead - Oncology
United States - Remote Apply NowJoin Amgen’s Mission of Serving Patients
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. 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.
Biospecimen Strategy Lead - Oncology
What you will do
Let’s do this. Let’s change the world. The Biospecimen Strategy Lead (BSL) is a pivotal senior manager-level role that sits at the intersection of science, operations, and strategy. Acting as the strategic architect of biospecimen plans within a Therapeutic Area (TA), this leader ensures Amgen’s biospecimen operations deliver scientific integrity, operational excellence, and meaningful impact on patient outcomes.
This position offers significant visibility and influence—partnering with scientific and operational leaders, as well as various governance bodies—while maintaining a hands-on role in shaping execution. It is ideal for leaders who excel at connecting strategy to action, navigating complex global environments, and inspiring collaboration across internal and external partners. The BSL represents Amgen’s voice in biospecimen strategy both internally and externally, driving innovation, continuous improvement, and long-term capability building.
Purpose:
- Lead the strategic direction of biospecimen operations across a Therapeutic Area, directly enabling Amgen’s ability to deliver transformative therapies.
- Provide strategic and operational oversight of biospecimen activities for Amgen clinical trials across a diverse portfolio of programs.
- Shape forward-looking sampling and testing plans that enable in-trial decision-making, translational research, and long-term scientific insights.
- Serve as a visible and trusted influencer to executive directors, VPs, and senior leaders, guiding decisions that impact scientific direction, portfolio execution, and patient outcomes.
- Champion innovation in biospecimen management by introducing best practices, emerging technologies, and digital solutions that improve efficiency, data integrity, and inspection readiness.
- Act as a thought partner and strategic advisor in governance settings, ensuring biospecimen strategy aligns with enterprise-level priorities.
- Inspire, mentor, and build biospecimen management capabilities across Amgen, shaping the next generation of leaders in this critical space.
- Represent Amgen externally in scientific forums, partnerships, and industry consortia, positioning the company as a leader in biospecimen strategy and execution.
Responsibilities:
- Partnering with senior leaders (PMLs, GBLs, PMed PMs) to define and deliver biospecimen strategies aligned with enterprise and TA priorities.
- Providing executive-level updates and shaping cross-TA strategy discussions.
- Anticipating organizational needs, identifying risks, and recommending strategic solutions.
- Leading escalation and resolution of cross-portfolio biospecimen challenges.
- Mentoring and developing cross-functional biospecimen leaders, building talent pipelines for the future.
- Serving as the senior point of contact for external partners and governance bodies.
- Ensuring regulatory inspection readiness and compliance with global health authority expectations for biospecimen processes.
- Influencing technology and systems alignment (e.g., LIMS, digital tracking platforms) to ensure biospecimen data integrity and operational efficiency.
- Participating in R&D governance forums and preparing clear, strategic reporting to senior partners.
- Partnering in the management of strategic partnerships and alliances with external labs, biobanks, and vendors to support program success and long-term capability building.
Key Activities:
- Strategic Program Leadership: Define and guide end-to-end biospecimen strategies across the TA; influence resource allocation and governance.
- Enterprise Visibility: Represent biospecimen operations in leadership forums; contribute to enterprise decision-making.
- Cross-Functional Engagement: Shape cross-functional collaboration, ensuring integration of biospecimen priorities across Clinical, Translational Sciences, and R&D.
- Innovation & Excellence: Lead the adoption of new tools, data strategies, and technology-enabled solutions to drive biospecimen operational excellence.
- Knowledge Management & Data Governance: Ensure biospecimen data and related documentation are reliable, accessible, and effectively integrated into enterprise systems.
- External Engagement: Represent Amgen in industry working groups, partnerships, and consortia to strengthen the company’s biospecimen capabilities and visibility.
- Financial Stewardship: Oversee biospecimen-related budgets and resource optimization to align with portfolio priorities and ensure fiscal responsibility.
- Change Management & Capability Building: Lead adoption of new practices and systems, provide training to partners, and embed biospecimen strategy into organizational culture.
- People Leadership: Mentor, coach, and develop biospecimen professionals; foster a high-performance culture of collaboration and accountability.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a [type of person] with these qualifications.
Basic Qualifications:
Doctorate degree in life sciences, clinical research, operations management, or a related field and 2 years of progressively responsible experience in biospecimen operations, clinical operations, or translational sciences
Or
Master’s degree life sciences, clinical research, operations management, or a related field and 4 years of progressively responsible experience in biospecimen operations, clinical operations, or translational sciences
Or
Bachelor’s degree life sciences, clinical research, operations management, or a related field and 6 years of progressively responsible experience in biospecimen operations, clinical operations, or translational sciences
Associate’s degree life sciences, clinical research, operations management, or a related field and 10 years of progressively responsible experience in biospecimen operations, clinical operations, or translational sciences
Or
High school diploma / GED and 12 years of progressively responsible experience in biospecimen operations, clinical operations, or translational sciences
Preferred Qualifications:
- 12–15 years of experience in biospecimen management, clinical operations, or translational sciences, with increasing responsibility and demonstrated ability to influence senior leadership (executive directors, VPs).
- Demonstrated ability to provide strategic recommendations and influence decision-making in cross-functional governance settings.
- Strong experience in cross-TA program management and vendor partnerships.
- Solid knowledge of cGXPs, SOPs, and international regulatory requirements relevant to biospecimen handling.
- Experience preparing materials for senior leadership forums and presenting to executive partners.
- Demonstrated mentoring and coaching of junior staff and ability to foster collaborative team culture.
- Proficiency in data and portfolio management tools (e.g., Smartsheet, PowerBI, analytics solutions).
- Strategic agility and enterprise mindset
- Highly effective leadership and cross-functional influence, with ability to credibly engage executive directors and VPs
- Ability to translate complex strategy into actionable outcomes
- Operational excellence, financial savvy, and decision-making under pressure
- Exceptional communication, stakeholder management, and executive presence
- Strong change leadership, training, and capability-building skills
- Knowledge management and data governance expertise
- Ability to drive innovation and inspire high-performing teams
- External engagement and industry collaboration skills
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:
- 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, including remote and hybrid work arrangements, where possible
Apply now and make a lasting impact with the Amgen team.
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Application deadline
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.
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.