Career Category
Clinical Development
Job Description
Associate Director, Database Design
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, Database Design provides enterprise leadership for database design strategy, governance, operating model evolution, modernization, and operational excellence across therapeutic area portfolios. The role drives transformation initiatives, enterprise standards, workforce planning, organizational capability development, and future-state database design capabilities while ensuring delivery of scalable, compliant, inspection-ready, and analytics-enabled database solutions across global portfolios.
- Roles & Responsibilities:
- Own and drive enterprise database design strategy across therapeutic area portfolios.
- Lead adoption and evolution of governance frameworks, reusable libraries, and validation methodologies.
- Lead workforce planning, talent development, and succession planning activities.
- Drive enterprise standardization and scalability of database design practices.
- Lead modernization initiatives including AI-enabled validation and automation.
- Partner with Digital & Technology organizations and cross-functional stakeholders.
- Provide strategic oversight of portfolio-level delivery, quality, compliance, and inspection readiness.
- Develop Senior Managers and functional leaders.
- Drive organizational design and capability development strategies.
- Lead continuous improvement and operational excellence initiatives.
- Lead leaders and Senior Managers across therapeutic areas to ensure alignment with enterprise objectives.
- Drive organizational design strategies and workforce evolution plans to support future-state database design capabilities.
- Influence enterprise clinical data strategy, operating models, and future-state clinical data capabilities.
- Lead governance forums and resolve complex database design, integration, and compliance issues across programs and portfolios.
- Mentor and develop Senior Managers and functional leaders while driving workforce planning and succession planning initiatives.
- Own enterprise database design operating model evolution for strategy, governance, modernization, and operational excellence across global portfolios.
- Ensure delivery of scalable, compliant, inspection-ready, and analytics-enabled database solutions across studies and programs.
- Lead and develop Senior Managers and functional leadership teams while driving standardization, automation, innovation, and organizational capability development.
- Influence enterprise database operating models, governance frameworks, digital transformation, and future-state clinical data capabilities.
- Drive portfolio-level operational performance, scalability, modernization, and continuous improvement initiatives aligned with enterprise objectives.
- Establish enterprise and therapeutic area database design strategy and governance frameworks.
- Approve portfolio-wide metadata standards, reusable libraries, validation methodologies, and modernization initiatives.
- Influence enterprise clinical technology roadmaps and automation strategies related to database design.
- Allocate leadership resources and prioritize portfolio-level database delivery activities.
- Escalate and resolve enterprise-level operational, compliance, and database design risks.
- Define organizational priorities, leadership expectations, and capability development strategies.
- Basic Qualifications and Experience:
- Doctorate degree and 10 years of relevant experience; OR
- Master’s degree and 13 years of relevant experience; OR
- Bachelor’s degree and 15 years of relevant experience.
- Minimum 5 years of people management experience, including experience managing managers, leading global teams, portfolios, organizational strategy, or enterprise resource planning activities within clinical development organizations.
- 15+ years of clinical research, clinical data management, or database design experience.
- Leadership experience with Vault CDMS, Medidata Rave, and enterprise clinical data ecosystems.
- Proven experience leading enterprise-scale transformation initiatives.
- Expertise in metadata-driven design and analytics-ready data solutions.
- Experience defining operating models, governance frameworks, and enterprise database delivery strategies.
- Demonstrated success leading organizational change and digital transformation initiatives.
- Experience building and leading high-performing global organizations and leadership teams.
- Strong portfolio leadership experience across complex global therapeutic area programs.
- Strong understanding of CDISC, SDTM, RBQM, inspection readiness, and regulatory compliance frameworks.
- Experience influencing executive stakeholders and enterprise-level strategic decisions.
- Enterprise leadership in database design strategy and clinical data modernization.
- Ability to shape enterprise-wide governance, operating models, and transformation frameworks.
- Strong executive communication, stakeholder management, and organizational influence skills.
- Strategic thinking combined with strong operational execution orientation.
- Expertise in automation, metadata-driven design, interoperability, AI-enabled validation, and scalable clinical data ecosystems.
- Ability to lead organizational transformation and enterprise modernization initiatives.
- Strong leadership development, mentoring, succession planning, and talent management capabilities.
- Ability to influence enterprise decisions across highly matrixed global organizations.
- Strong risk management, inspection readiness, and compliance leadership capabilities.
- Demonstrated ability to build scalable, high-performing global organizations and delivery models.
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 accommodation.
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