AddressHOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.
Director Information Systems - Global Patient Safety
Live
What you will do
Let’s do this. Let’s change the world. In this vital role you will be part of a diverse team that provides technology solutions for Global Patient Safety at Amgen. You’ll efforts to develop technology strategy and roadmaps; you’ll lead Agile Product Teams focused on Signal and Risk Management; you’ll lead M&A activities for the Safety technology team; you’ll provide Portfolio and Program Management support across the Safety technology ecosystem; and importantly, you’ll establish a new team leading all aspects of compliance and operational excellence across the Safety ecosystem.
Role Responsibilities:
Lead the global technology roadmap and strategy for Signal and Benefit Risk Management.
Establish and lead a team focused on all aspects of compliance and operational excellence across the Safety technology ecosystem.
Lead and manage technology professionals, invest in staff career development, and provide an environment of learning, risk taking, and partnership.
Analyze and explore industry trends and standard methodologies for innovative technology solutions for pharmacovigilance (PV) business domain.
Lead innovative efforts to transform Amgen's PV systems, improving and optimizing business efficiency and effectiveness.
Implement solutions that leverage robotic process automation, cognitive computing such as Natural Language Processing and Machine learning, and Generative Artificial Intelligence to thoughtfully automate and streamline manual processes.
Be an advocate for applying and reusing enterprise technology capabilities and standards.
Influence product roadmaps of key solution providers (internally and externally) and represent Amgen as a technology expert in industry consortia.
Take responsibly for the global performance of PV systems including compliance & inspection readiness.
Represent Safety IS in PV/ GCP audits and inspections.
Partner with Safety Leads globally on all matters related to Safety and PV compliance.
Collaborate with external vendors to ensure day to day support and maintenance of multiple systems, focusing on driving operational excellence through close partnership and effective communication.
Provide leadership for M&A activities with impact to the Safety technology ecosystem.
Manage the financial portfolio across the Safety technology ecosystem, including developing business cases, tracking commitment and spend, and managing license and maintenance contracts.
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Global Patient Safety professional we seek is a leader with these qualifications.
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
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 Qualifications:
10+ plus years of experience in Biopharma industry supporting a research and development technology organization.
10+ years leading validation efforts on large, multi-functional enterprise level initiatives in a GxP environment.
3+ years working with Safety and Pharmacovigilance technologies and business processes.
Background in health and/or life sciences and Information Technology.
Experience in collaborating with top executive leaders across key functions and Information Systems.
Experience using Integration and Automation technologies for enterprise level Safety processes in a large biopharma setting.
Solid understanding of current industry trends in Computer System Validation and regulatory agency guidelines, particularly regarding cloud-based solutions (SaaS) and risk-based validation.
Proficient understanding of Patient Safety business areas.
Experienced in FDA 21 CFR Part 11 compliance: thorough attention to details to guarantee systems are delivering to their intended use.
Ability to lead teams balancing operational excellence to ensure maximum availability and stability of our systems, and innovative technology to help transform Amgen’s Safety business.
Experience working in and leading agile practices and methodologies including Scaled Agile Framework (SAFe) in a regulated setting.
Hands on experience in leading and supporting Merger & Acquisition (M&A) Safety Integration execution strategy & activities.
Good project management, customer service and conflict resolution skills.
In-depth expertise in business analysis, as well as a comprehensive grasp of modern, cloud-based architecture.
Management of globally dispersed teams.
Ability to work in a highly matrixed environment and champion strong business partnerships.
Lead multiple projects simultaneously and deal with constantly evolving priorities.
Possess strong written, verbal communication, and presentation skills.
Demonstrate a positive demeanor and a good work ethic.
Outstanding interpersonal skills to influence at all levels, functions, & geographies.
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, or for field sales representatives, a sales-based incentive plan
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
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 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.
