Director, Clinical Data Management – Rare Disease
Location: United States – Remote
Job ID: R-222979
Date Posted: August 21, 2025
Work Type: Remote
Category: Clinical
Salary Range: $200,460 – $230,304 USD
(Salary will vary based on skills, experience, and qualifications)
About Amgen
At Amgen, our shared mission—to serve patients—drives everything we do. We are a global biotechnology leader delivering innovative therapies across four key areas:
Oncology
Inflammation
General Medicine
Rare Disease
With a reach of over 10 million patients worldwide, we are committed to transforming lives and defying what’s possible in science and medicine.
Role Overview: Director, Clinical Data Management (Rare Disease)
As a Director of Clinical Data Management, you will lead a team within Amgen’s Global Clinical Data Management (GCDM) group, contributing to the creation and optimization of a world-class clinical evidence platform. This role emphasizes strategic leadership, operational excellence, and functional oversight across rare disease studies.
You will drive data management strategy, resource planning, and cross-functional collaboration to ensure timely, high-quality clinical data delivery. You will also partner closely with internal teams and external Functional Service Providers (FSPs) to ensure alignment with Amgen’s clinical and business priorities.
Key Responsibilities
Leadership & Strategy
Lead a distinct data management (DM) unit focused on rare diseases or cross-product areas.
Set strategic direction for DM operations within your group.
Participate in Global Study Operations (GSO) leadership team to shape clinical delivery.
Represent DM in cross-functional and strategic planning forums.
Team & Resource Management
Recruit, train, manage, and develop internal DM staff.
Lead performance management, coaching, and career development.
Manage global resourcing plans, allocation, and budget tracking.
Process & Quality Oversight
Define and implement DM-related policies, SOPs, and standards.
Ensure compliance with regulatory requirements and internal quality standards.
Maintain Service Level Agreements (SLAs) and Key Performance Indicators (KPIs).
Respond to audits and inspections, ensuring CAPAs are implemented where needed.
Vendor & FSP Oversight
Oversee and manage FSP relationships (CROs, labs, imaging vendors).
Define governance frameworks, performance oversight, and escalation processes.
Ensure external teams are aligned with Amgen's strategy and priorities.
Operational Execution
Oversee data deliverables for clinical trials and regulatory submissions.
Ensure accurate, timely status reporting and act on emerging issues.
Lead or sponsor initiatives to improve operational efficiency, technology adoption, and innovation.
Basic Qualifications
One of the following combinations of education and experience is required:
Doctorate degree + 4 years of data management experience
Master’s degree + 8 years of data management experience
Bachelor’s degree + 10 years of data management experience
AND
Minimum of 4 years directly managing people or leading teams, projects, programs, or resource allocation (may overlap with technical experience).
Preferred Qualifications
Master’s degree in Life Sciences, Computer Science, Business Administration, or related discipline
8+ years experience in clinical data management within biotech or pharmaceutical industry
6+ years leadership experience in rare disease data management
Experience working in global, matrixed organizations
Vendor management and oversight of CROs, labs, and technology providers
Demonstrated ability to lead teams and make strategic business impact
Strong cross-functional collaboration and influencing skills
Familiarity with regulatory data standards and submission requirements
Proven project management skills and resource allocation expertise
Track record in driving innovation and continuous improvement
Excellent organizational, communication, and problem-solving skills
What You Can Expect from Amgen
Amgen provides a comprehensive Total Rewards Plan focused on supporting your health, financial security, and professional growth, including:
Compensation & Benefits
Competitive base salary + discretionary annual bonus
Stock-based long-term incentives
Retirement & Savings Plan with generous company contributions
Group health benefits including medical, dental, and vision insurance
Life and disability insurance
Flexible Spending Accounts (FSAs)
Work-Life Balance
Flexible work models, including remote work arrangements
Award-winning time-off policies and bi-annual company-wide shutdowns
Career Development
Learning and development opportunities
Leadership programs and cross-functional exposure
Application Process
Deadline:
There is no fixed deadline. Applications will be accepted until a candidate is selected.
Equal Opportunity Statement:
Amgen is an Equal Opportunity Employer. All qualified applicants will be considered regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.
Accommodations:
Amgen provides reasonable accommodation to individuals with disabilities during the application, interview, and employment process. Please contact us to request accommodation.
Apply Now
For a career that defies imagination, join us.
Submit your application at: careers.amgen.com
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