Amgen Principal IS Architect in Thousand Oaks, California

Job Summary

Amgen is seeking a Principal IS Architect at its main headquarters in Thousand Oaks, CA to join the Development IS team and report to the Director IS - Clinical Trial Management IS services.

The Principal IS Architect will be responsible for managing the technology ecosystem to enable Clinical Trial Management Systems (CTMS) that support the Global Development Operations (GDO) organization.

The current CTMS ecosystem mainly comprises of an Oracle -Siebel based eClinical and a field based COTS extension CRIMSON, integrations to electronic Trial Master File(e-TMF) and on-going integrations to support industry led implementations such as Shared Investigator Portal (SIP) and Investigator Registry (IR). eClinical is the primary source for Development Operational Data Store (Dev ODS). Dev ODS has a key dependence on this ecosystem.

The Principal IS Architect will be accountable for developing and continuously aligning the CTMS ecosystem with the rapidly changing business needs and Amgen IS technical roadmap such as transforming to new cloud-based technologies, and, as appropriate, eventual sun-setting of some of the applications based on other transformational initiatives within the Clinical Development and Information Systems organizations.

This role is required to possess strong domain expertise in Clinical Trial Management business processes and exceptional technical experience in CRM technologies and integration tools. This role is expected be highly proficient in the industry landscape of CTMS technical implementations and should be able to represent Amgen in industry forums, consortiums and symposiums to influence industry direction.

GDO is a critical business area with high impact on the design, startup and execution of Amgen Clinical Trials. Technology plays a vital role in support of this business area. Through the strategic use of technology and information, this position will help create competitive advantages for Amgen with industry leading cycle times.

Key Activities for a Principle IS Architect include:

  • Own and shape the design and technology of CTMS ecosystem.

  • Partner with the Dev IS service owners and GDO-- Clinical Systems and Analytics (CSAR) function and develop a vision and multi-year roadmap for the lifecycle management of the applications. Collaborate with the service owners, existing support team and the application run management to maintain and support the systems.

  • Manage the execution of a varied portfolio of IS projects with appropriate portfolio planning, resource and risk management and financial management for the portfolio

  • Shaping Amgen's future - Keep track of industry and technology trends, connect and foster external networking opportunities to deliver valuable insight from other similar professionals in our industry.

  • Ensure scalability, cost-effective design, development, and engineering in both short and long-term timeframes through the effective employment of various suppliers and enterprise COEs (e.g. Enterprise Architecture, Enterprise BI, Solution Developers etc.)

  • Effectively manage relationships with Dev IS service owners, business partners, enterprise IS service partners, and vendors

  • Accountable to elicit and analyze needs identified by business stakeholders and convert them into functional design.

  • Travel: Domestic and international travel up to 25% might be essential

Basic Qualifications

Doctorate degree and 2 years of Information Systems experience

OR

Master's degree and 6 years of Information Systems experience

OR

Bachelor's degree and 8 years of Information Systems experience

OR

Associate's degree and 10 years of Information Systems experience

OR

High school diploma / GED and 12 years of Information Systems experience

AND

2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications

  • In depth knowledge of the Clinical Trials domain and business functions - processes, tools, data standards, artifacts and systems (CTMS, IVRS, Clinical data management (CDM) systems - Rave Medidata)

  • Strong experience in programming Siebel applications and other CRM technologies

  • A proven track record of development and technical management of Clinical Trial Management Systems, specifically Oracle Siebel CTMS

  • Architect and implement technology solutions for clinical trial operations including configuring workflows and forms

  • Strong experience in methods and technologies to support Clinical System integrations (e.g. ETL- Informatica, Web Services/messaging, data mapping)

  • Experience in translation business requirements into innovative technical solution building complex database applications

  • Experience in identifying business opportunities and turning functional requirements into solutions that address difficult business challenges using IS solution

  • Ability to combine strategic business and technical direction, and translate concepts into actionable implementation plans

  • Experience with Veeva and Salesforce platforms are a definite plus.

  • Experience with all phases of SDLC (Software Development Life Cycle) and use of Agile/SCRUM methodologies

  • Experience in supporting regulated/validated systems (Good Clinical Practices (GCP) systems) and understanding of 21CFR Part 11 requirements

  • Proven ability to work and lead in a dynamic environment with little supervision

  • Proven track record of managing project portfolio, financial management and project execution

  • Combined qualities of a good salesman, a caring teacher or coach, an enthusiastic inventor, a careful analyst, and a knowledgeable engineer

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.