Director Clinical Data Management - Rare Disease

Director Clinical Data Management

Live

What You Will Do

Let’s do this. Let’s change the world. The Amgen Global Clinical Data Management team is looking for an experienced Director to lead our data management team on the aspiration of optimizing and delivering an industry admired clinical evidence platform to deliver innovative medicines to patients with unmet medical needs.

The Director is accountable for leadership and oversight of the data management organization; ensuring operational excellence and consistency in clinical trial execution. They are accountable for building and developing a high performing internal data management team, as well as ensuring engagement and alignment of Amgen’s strategy and priorities with the Functional Service Provider (FSP).

The Director is also part of the Global Study Operations (GSO) leadership team, accountable for the delivery of quality clinical trials through industry-leading execution of innovative processes, strong cross-functional partnerships, and best-use of clinical systems and analytics to guide site and study operations. The role will support acceleration of clinical programs and other continuous improvement efforts, applying innovative thinking in shaping future strategy.

Our Global Clinical Data Management Team:

The Global Clinical Data Management Team comprises approximately 50 people. The three Directors, as part of the wider GSO organization and reporting into the Executive Director, Global Study Operations, work together to meet the demands of an industry leading, fast paced, high throughput organization with a commitment to compliance, quality and standards.

Director Clinical Data Management role overview:

You will lead and manage Data Management (DM) teams within a specific DM operational business unit. The Director will set and drive forward the vision and strategy for DM as a member of the DM and GSO Leadership Team.

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
• Be an active member of the Leadership Team to provide a foundation for GSO success
  

Key activities will include:

• Team management including performance, coaching and development
• Develop, review and implement policies, SOPs and associated documents affecting DM globally
• Set vision, strategy and direction for DM group; develop annual goals and objectives
• Accountable for and oversee DM FSP relationships; ensuring goals of product areas and systems groups can be met via the FSP
• Define and maintain Service Level Agreements and Key Performance Indicators; including oversight of quality and CAPA management
• Governance oversight -ensure visibility into performance of FSPs to the department
• Sponsor, Lead and participate in cross functional working groups
• Resource and budget management for global function Ensure adequate training and capability within area and be accountable for staff compliance with all DM processes
• Vendor management (development of strategies, contract management, relationship management, etc)
• Respond to audit/inspection findings
• Be accountable for and oversee all study deliverables and submission activities for products within group
• Ensure that status information on DM activities is available and is acted on as needed
  

Win

What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. The data management professional we seek is a collaborator with these qualifications.

Basic requirements:

Doctorate degree and 4 years of data management experience
OR
Master’s degree and 8 years of  data management experience experience
OR
Bachelor’s degree and 10 years of  data management experience experience

In addition to meeting at least one of the above requirements, you must have at least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.  Your managerial experience may run concurrently with the required technical experience referenced above 

Preferred Experience:

• Master’s degree or equivalent in life science, computer science, business administration or related discipline
• 8+ years Extensive experience in data management in the Pharmaceutical or Biotech arena
• 6+ years 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 (CRO’s, central labs, imaging vendors, etc)
• 6+ 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
• Previous experience in a global, matrix organization
• Excellent organizational and interpersonal skills
• Ability to anticipate and problem solve challenging issues

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being. 

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors, including but not limited to, relevant skills, experience, and qualifications. 

Amgen offers a Total Rewards Plan comprising 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 including: 

• 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. 

• 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. 

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

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.

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.