Career Category

Job Description

Purpose

•Leads and manages the Site Management operations activities in JAPAC region

•Assesses and determines regional contribution to feasibility, study placement, subject recruitment and monitoring functions within GSO in support of Amgen-sponsored clinical trials

•Ensures adherence to Amgen standards and all applicable regulations

Responsibilities

•Building and maintaining Amgen capabilities for clinical trial conduct in the region

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

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

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

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

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

Key Activities

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

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

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

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

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

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

•Advises 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

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

Qualifications:

Doctorate degree & 4 years of clinical experience OR

•      Master’s degree & 8 years of clinical experience OR

•      Bachelor’s degree & 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 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.)

Knowledge

•      Basic scientific/medical/clinical knowledge

•      In-depth understanding of drug development process, clinical trials conduct, ICH- GCP guidelines and FDA regulations

•      Regional expertise

•      Cross-cultural knowledge

•      Finance and budgeting

•      Detailed understanding of customer service as it applies to clinical research

•      Extensive understanding of project management principles and implementation

•      Familiarity with speed, productivity, cost and quality metrics

Amgen

We are one of the world’s leading biotechnology companies, with a particular focus on cardiovascular disease, oncology, bone health, neuroscience, nephrology and inflammation. And we put much of our success discovering and producing medicines and therapies down to our biology first approach.  

In short, this is a place for innovation. Where ideas are not just welcome, but celebrated. Where you will have a peer group of 20,000 inspirational colleagues, not to mention the resources only a $20bn+ business can provide. This is your chance to make a positive impact on the world.  

The benefits 
Our holistic approach is one of the reasons why we are regularly recognized as a ‘Best Place To Work’ – you will find us focused on your wellbeing too.