Biospecimen Strategy Lead - Oncology at Amgen
Washington, DC 20004, USA -
Full Time


Start Date

Immediate

Expiry Date

29 Nov, 25

Salary

178451.0

Posted On

29 Aug, 25

Experience

12 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Operations Management, Materials, Clinical Operations, Vendor Partnerships, Regulatory Requirements, Operational Excellence, Training, Decision Making, Clinical Research, Team Culture, Knowledge Management, Coaching, Stakeholder Management, Program Management

Industry

Pharmaceuticals

Description

JOIN 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.

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
Responsibilities

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.
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