Associate Vice President, Clinical Data Management

Career Category

Job Description

JOIN AMGENS MISSION OF SERVING PATIENTS

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds 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 youll 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 youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

ASSOCIATE VICE PRESIDENT CLINICAL DATA MANAGEMENT

Live

What you will do

The Associate Vice President Clinical Data Management is a member of the Global Development Operations (GDO) leadership team and is a strategic partner to the R&D organization.

You will lead Amgens Clinical Data Management function within GDO ensuring the highest quality of clinical data collection processing and analysis to support regulatory submissions and clinical development programs. This role is responsible for the strategic direction leadership and operational oversight of data management processes supporting clinical trials across all therapeutic areas and phases.

You will collaborate closely with cross-functional teams including clinical operations biostatistics regulatory affairs and quality to drive data integrity and compliance with global regulatory standards.

The role requires a visionary leader with deep expertise in CDM and a proven ability to scale and lead global teams in a complex matrix environment.

Responsibilities:

• Develop and drive the global data management strategy in alignment with clinical development objectives and corporate goals.

• Provide strategic and operational leadership to the Clinical Data Management (CDM) function across all clinical programs and phases.

• Lead innovation initiatives including the implementation of development integration programs and the adoption of cutting-edge technologies to enhance data workflows.

• Represent Clinical Data Management in executive leadership discussions regulatory interactions and industry forums.

• Establish and enforce robust clinical data governance models policies and risk mitigation strategies to ensure quality and compliance.

• Make final decisions regarding standard operating procedures (SOPs) CDM best practices and process optimization.

• Engage key stakeholders and ensure timely resolution on critical data integrity and regulatory compliance issues.

• Serve as the primary CDM representative during regulatory inspections and audits with responsibility for final decisions on findings responses and corrective actions.

• Influence cross-functional clinical development operational and regulatory strategies through data-driven insights and analytics.

• Partner closely with Clinical Program Operations Regulatory Biostatistics and R&D to ensure seamless integration and alignment of clinical data.

• Build and maintain strategic relationships with CROs vendors regulatory authorities and industry organizations to advance CDM excellence.

• Influence internal leadership and functional partners to promote data-driven decision-making across clinical programs.

• Lead audit readiness efforts and promote a culture of continuous improvement and compliance within the CDM function.

• Implement protocols and tools to ensure data security integrity and risk management across all platforms and studies.

• Optimize staffing outsourcing strategies and technology investments to improve cost-efficiency scalability and delivery timelines.

Win

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The candidate we seek is an experienced leader with the following qualifications.

Basic Qualifications:

• Degree educated in relevant discipline

• Extensive data management experience including managerial experience directly managing people and/or leadership experience leading teams projects programs or directing the allocation of resources

Preferred Qualifications:

• Experience within clinical data management regulatory compliance and strategic leadership within a pharmaceutical biotech or CRO environment.

• Expertise in GCP ICH FDA EMA regulations data governance and clinical trial data standards (CDISC SDTM).

• Experience within cross-functional collaborations leadership and strategic planning skills ensuring operational excellence and compliance while driving innovation in data management to support Amgens global clinical development efforts.

• Expertise in AI/ML-driven data management solutions automation and advanced analytics.

• Understanding of clinical data standards (CDISC SDTM ADaM).

• Experience leading regulatory submissions including NDA/BLA/MAA filings and advisory committee interactions

• Proven ability to drive organizational change optimize processes and implement lean principles in clinical data management.

• Cross-functional collaboration experience with clinical operations regulatory affairs biostatistics and R&D teams.

• Experience managing FSP relationships and technology implementations (EDC CTMS RWD/RWE).

• Knowledge of emerging trends in digital health data governance and data privacy regulations (GDPR HIPAA).

• Familiarity with decentralized trial models and digital health technologies.

The successful candidate will also embody the Amgen leadership attributes which are:

• Inspire: Create a connected inclusive and inspiring work environment that empowers talent to thrive

• Accelerate: Enable speed that matches the urgency of patient needs by encouraging progress over perfection

• Integrate: Connect the dots to amplify the collective power of Amgen to drive results for patients staff and shareholders

• Adapt: Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results

Thrive

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 well support your journey every step of the way.

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.