Director, Clinical Data Management

Role Overview: You will lead and manage Data Management (DM) teams within a specific DM operational business unit. As the Director of Clinical Data Management at Amgen, you will set and drive forward the vision and strategy for DM as a member of the DM and Global Study Operations (GSO) Leadership Team. You will be responsible for overseeing a distinct DM operational unit, recruiting, managing, and developing staff, setting functional goals and objectives, and ensuring DM processes and systems meet regulatory and business requirements. Additionally, you will play a key role in providing a foundation for GSO success. Key Responsibilities: - Oversight of a distinct DM operational unit (e.g. therapy area, cross-product area) - Recruiting, managing and developing staff - Global resource planning and assignments - Setting of functional goals and objectives - Creating and implementing GSO & DM strategies - Developing, reviewing, implementing and enforcing data standards - Ensuring DM processes/systems meet regulatory and business requirements - Active member of the Leadership Team to provide a foundation for GSO success - Team management including performance, coaching, and development - Develop, review and implement policies, SOPs and associated documents affecting DM globally - Define and maintain Service Level Agreements and Key Performance Indicators - Oversight of quality and CAPA management - Governance oversight to ensure visibility into performance of FSPs - Vendor management including development of strategies, contract management, and relationship management - Respond to audit/inspection findings - Accountable for and oversee all study deliverables and submission activities for products within group Qualification Required: Basic requirements: - 18 to 23 years of data management experience Preferred Experience: - Masters degree or equivalent in life science, computer science, business administration, or related discipline - 10+ years of extensive experience in data management in the Pharmaceutical or Biotech arena - 8+ years of experience in rare disease therapeutic area, in a leadership role - Broad experience of working in a global organization - Experience at or oversight of outside vendors (CROs, central labs, imaging vendors, etc) - 8+ years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources - Strategic and innovative thinker with experience of driving operational excellence - Excellent relationship building skills with the ability to influence and make business impact - Ability to work collaboratively cross functionally with ability to influence and drive decisions - Proven experience within oversight of clinical research suppliers - Project management skills - Previous experience in a global, matrix organization - Excellent organizational and interpersonal skills - Ability to anticipate and problem solve challenging issues,