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Director, Clinical Data Management – Rare Disease

4 years years
$200,460 – $230,304 USD
10 Sept. 2, 2025
Job Description
Job Type: Remote Education: 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 Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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