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Amgen Director and Regional Head Clinical Site Mgmt in Thousand Oaks, California

The Director and Regional Head role will lead and manage the Site Management operations activities in the Americas region. The Director will assess and determine regional contribution to feasibility, study placement, subject recruitment and monitoring functions within GSO in support of Amgen-sponsored clinical trials. In addition, ensure adherence to Amgen standards and all applicable regulations.

Responsibilities:

  • Build and maintain Amgen capabilities for clinical trial conduct in the region

  • Act as first point-of-contact for teams considering inclusion of region to conduct clinical studies

  • Ensure timely, high-quality data from Amgen-sponsored clinical trials in the region

  • Budget and resourcing for the region & oversee management of Functional Service Providers

  • Oversee operational aspects of clinical study conduct and compliance, and promoting operational excellence in countries within the region

  • Ensure cross-functional regional and global alignment through establishing and maintaining process standards

  • Subject matter expert, single point-of contact and escalation route for assigned Global Study Operations (GSO) operating region including contribution to functional strategic direction

  • Work with Country/Regional Medical Director(s) to hire and manage DOMs and contribute to their career development

  • Manage regional budget and resources, and determine strategy for resource capacity management

  • Promote operational excellence to ensure quality, compliance and efficiency, and ensure delivery to commitments in study execution

  • Promote innovation and support global and functional initiatives where appropriate, including global alignment within GSO, Global Development Operations (GDO) and Therapeutic Areas (TA)

  • Facilitate the sharing of best practices and lessons learned in the region/countries

  • Advise on study placement through cross-functional collaboration with GDO and TAs

  • Accountable for selection of Functional Service Provider (FSP) vendor(s) within the region supporting monitoring activities

  • Support regional/country oversight activities of FSP vendor(s)

Basic Qualifications:

Doctorate degree and 4 years of clinical experience

OR

Master’s degree and 8 years of clinical experience

OR

Bachelor’s degree and 10 years of clinical experience

AND

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

Preferred Qualifications:

  • M.D., D.O., PhD, PharmD, Master’s Degree

  • 11+ years of work experience in life sciences or medically related field, including 8+ years of biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)

  • Previous management experience of direct reports, including management level staff

  • Experience at, or oversight of, outside clinical research vendors (CRO’s, central

  • labs, imaging vendors, etc.)

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

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.

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