Associate Director Global Clinical Program Management, Obesity

at  Amgen

HOW 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.

BASIC QUALIFICATIONS:

• Degree in relevant field with life sciences or medically related experience work
• Experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.

PREFERRED QUALIFICATIONS:

• Experience in life sciences or medically related field, including biopharmaceutical clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company
• Previous management experience with direct reports
• Experience at or oversight of outside clinical research vendors (CRO’s, central labs, imaging vendors, etc.)

Let’s do this. Let’s change the world. In this vital role you will coordinate and lead all aspects of the operational strategy, planning, risk assessment and mitigation, and overall delivery of Obesity clinical trial programs globally and support continuous improvement initiatives in Clinical Program Operations (CPO) and Global Development Operations (GDO).

Responsibilities:

• Line Management of Global Trial Managers (GTM)s
• Supports Clinical Program Operations (CPO) Director/Snr Director in the following activities (leads activities in the absence of a director level e.g., on smaller programs):
• Overall delivery of Global clinical program operational strategy, planning, risk assessment and mitigation
• Deliver high-quality clinical trials on time and within budget
• Supports / Leads the Global Clinical Study Team for the allocated program(s)
• Providing clinical operations leadership and expertise on the Evidence Generation Team (EGT) and in development of the Evidence Generation Plan (EGP)
• Provide clinical operations leadership and expertise in EGP delivery through the feasibility and study design process
• Development and oversight of clinical program budgets in collaboration with Therapeutic Area (TA) and Finance
• Managing program-level operational issues and oversight of study team issues
• Maintaining global business relationships cross-functionally and communicating global status of clinical trial programs to senior management
• Representing CPO on process improvement initiatives
• Support CPO resource planning for assigned program(s) in collaboration with Program Resource Management (PRM) and Clinical Program Management Director (CPM-D)

Key Activities:

• Lead all aspects of people management, career development, training and succession planning of GTMs
• Support and mentor GTMs in people management, career development of respective Local Trial Managers (LTMs)
• Supports the Global Clinical Program Management Director/ Snr Director in leading all aspects of the planning and delivery of all studies for the program. Accountable for all studies in the program if no director level present
• Input into product evidence generation plans
• Initiate and support conduct of Country Operational Landscape Assessments and study feasibility with Development Feasibility Senior Managers
• Contribute operational expertise throughout Study design coordinating cross functional input on a continuous basis
• Provide advice on development of Key Design Elements (KDE) prior to Governance Body review
• Provide insight to study cost drivers and assumptions as refined throughout KDE and protocol development
• Provide advice on the operational impact of clinical trial regulations on study assumptions and design - for example In Vitro Diagnostics Regulation (IVDR)
• Facilitate with protocol development
• Support and provide advice in the development of the evidence generation plan at EGT
• Lead cross-functional team to build and periodically review/revise program & study Clinical Trial-Risk Assessment Categorization Tool (CT-RACT)
• Evaluate if “Patient Voice” techniques should be incorporated on program and design, implement and measure the success of subject Recruitment and Retention Strategies
• Support in program / study level diversity plans
• Support / Accountable for study global enrollment plans revised enrollment plans and accurate global recruitment forecasting
• Support the resolution of cross-functional study / program issues raised from the study teams and inform / raise to CPM Director as appropriate advance to TA Head and other partners if no director is present
• Supports / Leads program level meetings to ensure operational consistency and standards across all clinical studies within the program
• Communicate well with key partners the program strategy and deliverables
• Support functional goal setting
• Facilitate sharing of optimum practices, product knowledge and identify areas for process improvement within CPO
• Review vendor evaluation to include identification of outsourcing requirements for study / program and be responsible for management of vendors.
• Supports and is responsible for internal audit and inspection activities and contributes to CAPAs globally for the program
• Lead planning for regulatory agency inspection readiness activities (e.g. TMF review) and ensure delivery of plans
• Represent the function by contributing and / or leading initiatives for the continuous improvement of clinical trial planning and delivery. Contribute to development and maintenance of policies, SOPs and associated documents
• Depending on the stage of the program, may lead studies (refer to GCTM blueprint for additional information on study management)