Job Details 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 Lets do this. Lets change the world. 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.
The AVP 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.
This AVP 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: - Doctorate degree & 7 years of data management experience OR
- Masters degree & 10 years of data management experience OR
- Bachelors degree & 12 years of data management experience AND
- 7 years of 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.
They 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.
The annual base salary range for this opportunity in the U.S. is $331,502 - $405,169.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible
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.
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
