Job Description

Career Category

Clinical Development

ABOUT AMGEN

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.

ABOUT THE ROLE

The Associate Director, Program Data Delivery provides program-level leadership in complex programs and will be accountable for ensuring high-quality, inspection-ready data across studies and programs as needed , driving alignment, consistency, standardization, scalability, and innovation from study planning through database lock.

This role leads and mentors a pod of Data Delivery Leads and Central Monitors ensuring standardized, scalable, and inspection-ready delivery across the portfolio.

The Associate Director serves as the strategic Data Management leader, responsible for shaping delivery models within a therapeutic area, influencing cross-functional decisions, and driving continuous improvement and innovation across programs.

STRATEGIC PILLAR

• Define and drive Data Delivery strategy at the program level, aligned to GDO priorities
• Shape and evolve operating models for Program Data Delivery and Central Monitoring, including monitoring of resource needs, governance, and delivery frameworks
• Lead standardization and modernization initiatives (e.g., integrated data review approach, risk-based data management, advanced automation, etc.) across programs
• Influence portfolio prioritization, risk trade-offs, and execution strategies in partnership with Clinical Operations, Biostatistics,Safety, and Medical Monitoring
• Represent Data Management in senior governance forums, providing strategic insights and recommendations
• Build sustainable and scalable capability models (talent, tools, and processes) to support portfolio growth

Roles & Responsibilities:

Portfolio & Program Delivery Oversight

• Accountable for end-to-end delivery of high-quality, inspection-ready clinical data across multiple programs, ensuring adherence to timelines, regulatory requirements, and quality standards, while driving consistent database readiness, data cleaning, reconciliation, and seamless database lock execution.
• Drive program-level adoption and cross-study standardization of data management practices - including DMP, IDRP, query management, and reconciliation—to improve efficiency, consistency, and scalability across programs
• Manage inter-study dependencies, timelines, and critical paths to ensure seamless program execution and delivery alignment
• Drive adoption of advanced analytics, automation, and AI-enabled data review to enhance data quality, efficiency, and insight generation
• Ensure continuous inspection readiness and proactively support regulatory inspections and audits

Leadership of Program Data Delivery & Central Monitoring

• Lead pods of Data Delivery Leads, and Central Monitors and mentor Program Data Delivery Leads
• Drive consistent execution through clear expectations and performance accountability
• Build leadership capability and pipeline through mentorship and development
• Ensure effective central monitoring for early risk detection

Risk Management & Governance

• Own portfolio-level risk strategy, including identification, escalation, and mitigation
• Translate program risks into portfolio insights and proactive actions
• Lead governance forums and drive resolution of complex cross-functional issues
• Serve as escalation point for critical data delivery risks

Metrics, Insights & Decision Support

• Oversee key program metrics, ensuring timely actions, resolution, and closure of identified issues
• Leverage analytics to identify trends, risks, and improvement opportunities across programs
• Provide clear, actionable portfolio insights to senior leadership, enabling informed, data-driven decisions and effective trade-off management

Cross-Functional & Vendor Leadership

• Influence across Clinical Operations, Biostatistics, Safety, Systems, and vendors
• Align program execution with portfolio and enterprise priorities
• Oversee vendor performance and delivery quality at scale

Process Excellence & Transformation

• Drive adoption of standardized methodologies and best practices
• Lead improvements to enhance efficiency, scalability, and quality
• Champion innovation in central monitoring and data review

Basic Qualifications and Experience:

• Doctorate /Master’s Degree /bachelor’s degree with 15+ years of experience in life sciences / clinical data management
• Proven experience leading programs/portfolios in clinical data management
• Demonstrated people leadership and organizational management experience.

Preferred Experience:

• 15+ years’ work experience in life sciences or medically related field, including 10 years of managing data on biopharmaceutical clinical research experience
• Extensive experience in Program Data Delivery and Central Monitoring models
• Strong experience in portfolio oversight across multiple global clinical trials
• Demonstrated ability to operate at both strategic and execution levels
• Experience influencing in matrixed, global environments
• Experience leading teams, transformation and modernization initiatives
• Experience engaging and working across clinical trial teams in multiple geographies to deliver global clinical trials
• Experience with managing data collection and oversight with external vendor (CROs, central labs, imaging vendors, etc.)
• Experience with risk-based monitoring models / risk-based quality management, and/or clinical site management.

Functional Competencies:

Must-Have Competencies:

• Ability to lead portfolio-scale delivery and influence enterprise-level decisions
• Strong capability to identify cross-program risks and drive mitigation strategies
• Expertise in interpreting complex clinical and operational data to guide portfolio execution
• Ability to drive standardization, scalability, and innovation across programs
• Proven ability to build, develop, and lead high-performing teams across geographies
• Strong experience managing vendors and cross-functional dependencies at scale
• Ability to drive change and adoption of new operating models across the organization

Soft Skills:

• Strong executive presence and communication skills
• Ability to influence senior leadership and cross-functional stakeholders
• Strategic thinking combined with strong execution orientation

EQUAL OPPORTUNITY STATEMENT

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided with 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 an accommodation.