DIRECTOR CLINICAL DATA MANAGEMENT
Overview
At Amgen, every challenge is an opportunity. Our mission is to serve patients and advance biotechnical and biopharmaceutical science to help those with unmet medical needs.
What You Will Do
The Amgen Global Clinical Data Management team is looking for an experienced Director to lead our data management team with the aim of delivering an industry– admired clinical evidence platform to bring innovative medicines to patients with unmet medical needs.
You will lead and manage Data Management (DM) teams within a specific DM operational unit. The Director will set and drive the vision and strategy for DM as a member of the DM and GSO Leadership Team. You will be accountable for leadership and oversight of the DM organization, ensuring operational excellence and consistency in clinical trial execution. You will build and develop a high-performing internal DM team, and ensure engagement and alignment of Amgen’s strategy with the Functional Service Provider (FSP).
You will be part of the Global Study Operations (GSO) leadership team, accountable for delivering quality clinical trials through innovative processes, cross-functional partnerships, and effective use of clinical systems and analytics to guide site and study operations. The role supports acceleration of clinical programs and continuous improvement efforts, shaping future strategy.
Our Global Clinical Data Management Team comprises approximately 50 people. The three Directors, as part of the wider GSO organization, work to meet the demands of a fast-paced, high-throughput organization with a commitment to compliance, quality and standards.
Responsibilities
* Oversight of a distinct DM operational unit (e.g., therapy area, cross‑product)
* Recruiting, managing and developing staff
* Global resource planning and assignments
* Setting 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
* Be an active member of the Leadership Team to support GSO success
Key activities
* Team management including performance, coaching and development
* Develop, review and implement policies, SOPs and related documents affecting DM globally
* Set vision, strategy and direction for the DM group; develop annual goals
* Accountable for DM FSP relationships; ensuring goals of product areas and systems groups can be met via the FSP
* Define and maintain Service Level Agreements and KPIs; oversight of quality and CAPA management
* Governance oversight – ensure visibility into FSP performance
* Sponsor, lead and participate in cross-functional working groups
* Resource and budget management; ensure training and staff compliance with DM processes
* Vendor management (strategy, contract management, relationship management)
* Respond to audit/inspection findings
* Oversee study deliverables and submission activities for products within the group
* Ensure DM activity status information is current and acted on as needed
What We Expect Of You
We value collaboration and the unique contributions of our team. The data management professional we seek is a collaborator with these qualifications.
* Degree in a relevant field (life sciences, computer science, business administration or related)
* Extensive data management experience in Pharma/Biotech
* Leadership experience in rare disease therapeutic area
* Experience in global organizations and oversight of outside vendors (CROs, central labs, imaging vendors, etc.)
* Extensive managerial experience leading teams, projects, programs or resource allocation
* Strategic and innovative thinker with operational excellence experience
* Excellent relationship-building skills with ability to influence and drive business impact
* Collaborative cross-functional work with influence to drive decisions
* Experience overseeing clinical research suppliers
* Project management
* Global, matrix organization experience
* Excellent organizational and interpersonal skills
* Ability to anticipate and solve challenging issues
Thrive
We invest in your growth and well-being as we work to develop treatments that help others.
* Opportunities to learn and move across our global organization
* Diverse and inclusive community that values ideas and action
* Generous Total Rewards Plan including health, finance and wealth, work/life balance
Location
Ability to work flexibly from home with regular office work from our Cambridge or Uxbridge next-generation workspace.
Apply Now
for a career that defies imagination
Join us in serving patients above all else. Amgen is the first to imagine, and the last to doubt.
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Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We provide reasonable accommodations in the job application or interview process upon request.
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