Director Information Systems–Global Regulatory Affairs & Safety IS Services

  • Company: Amgen
  • Posted: January 28, 2017
  • Reference ID: R-33339
Amgen is seeking Director, Information Systems, at its main headquarters in Thousand Oaks, CA reporting to the Executive Director of R&D Informatics-Head of Development IS. The director will primarily be responsible for leading IS Services for three business capabilities within Global Regulatory Affairs and Safety (GRAAS) organization: Global Patient Safety, Global Labeling, and Global Regulatory Affairs and CMC. Partner with key business leaders to understand the business imperatives, efficiency gaps, and regulatory/compliance requirements and partner/consult with industry peers and other IS & GBS service owners to define IS strategy and technology roadmap.
Development IS team is dedicated to providing innovative and regulatory compliant IS solutions to Global Clinical Development and GRAAS to help streamline clinical trial design & execution, reduce regulatory submissions cycle time, and ensure patient safety.
Travel: Domestic and International travel up to 10% may be essential.
Keep abreast of emerging technologies in the areas of business process automation, social media listening, natural language processing, digital health, data mining, analytics, and visualization to apply innovative approach in implementing solutions to enhance these business capabilities and position Amgen ahead of its peers
Shape Amgen's future IS roadmaps - track and evaluate business (GRAAS) and technology trends, connect and foster external networking opportunities to deliver valuable insights from other similar professionals in our industry.
Demonstrated ability to combine strategic business and technical direction, and translate concepts into actionable implementation plans
Accountable for "Run" and "Build" project portfolio execution and ensure all systems are GxP compliant, inspection ready, and meet Amgen's IS security standards
Lead a team of IS professionals, invest in staff career development, and provide an environment of learning, risk taking, and collaboration.
Manage the execution of a varied portfolio of IS projects with appropriate portfolio planning, financial, resource, vendor and risk management, leveraging agile approaches for flexible and nimble execution.
Oversee external vendors that provide day-to-day support and maintenance of several systems; working closely with the vendors to drive operational excellence
Basic Qualifications
Doctorate degree and 4 years of Information Systems experience
OR Master's degree and 8 years of Information Systems experience
OR Bachelor's degree and 10 years of Information Systems experience
4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Preferred Qualifications
Excellent executive level influencing skills, with demonstrated ability to work collaboratively and effectively with key business partners, IT leadership teams, and external services providers.
Demonstrated ability for strategic IT planning and roadmap development.
Working knowledge of LEAN/AGILE software development methodologies.
Experience in enhancing organizational talent through staff development.
Strong influence and leadership skills, ability to operate across boundaries (internally/externally)
Organizational change management and project management skills
Experience in the pharmaceutical and/or healthcare industry
Experience in implementing and supporting systems for Pharmacovigilance, Regulatory Affairs, or Labeling systems.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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, or disability status.

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