Associate Director Global Clinical Program Management

Career Category

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Associate Director Global Clinical Program Management

What you will do

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