Director, Operational Design Analytics

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.

Director, Operational Design Analytics

What you will do

Let’s do this. Let’s change the world. The Director, Operational Design Analytics will lead the Operational Design Analytics Team to advance study teams’ use of data in feasibility planning and support, enrolment projection modelling, and country selection. The ODA Director is a key member of the Operational Design Team in driving integrated and operationally achievable protocols.

The Operational Design Analytics (ODA) team:

• A team of Operational Design Analytics Senior Managers and Managers who work with study teams during trial design, planning, and start-up to drive the use of data to inform operational planning and improve the probability of executing within schedule and budget.

The Operational Design Team (ODT):

• The ODA Director is a member of the ODT Leadership Team, integrating feasibility, operational analytics, study design, patient engagement, and recruitment/retention efforts in study design and start up

The Director, Operational Design Analytics joins the Clinical Program Operations (CPO) function. You will play a key role across Global Development as part of the ODT Leadership Team to drive realization of the full potential of data sources at Amgen to support evidence based optimized operational planning and an operationally integrated feasible study design.

We are excited to unite with the most hardworking and forward-thinking scientific minds who want to join Amgen– working toward our mission of advancing high potential programs for patients around the world.

Responsibilities:

• Lead and manage the team and develop staff
• Drive strategy and execution for the use of data sources in operational design and planning to improve predictability and speed of execution
• Enable and support continued evolution of the Operational Design Analytics roles
• Partner with Clinical Program Managers to ensure understanding and utilization of data sources in enrolment projection.
• Partners with Global Network Leads and Business Process Owners to advance processes in support of the new capabilities and roles.
• Collaborate with stakeholder functions including Center for Design and Analytics (CfDA) Data Sciences, Center for Observational Research (CfOR) and Global Development Operations (GDO) leadership to identify new opportunity and findings to support planning and execution of clinical trials
• Demonstrate external knowledge of industry standard methodologies, processes and new trends
• Support introduction and scaling of significant operational innovations

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The qualified professional we seek is a Clinical Director with these qualifications.

Basic Qualifications:

Doctorate degree and 4 years of Clinical experience

OR

Master’s degree and 7years of Clinical experience

OR

Bachelor’s degree and 9 years of Clinical experience

Preferred Qualifications:

• M.D., D.O., PhD, PharmD, MSc
• 11+ years work experience in life sciences or medically related field, including 8+ years of biopharmaceutical clinical research experience obtained working in clinical development at a biotech, pharmaceutical or CRO
• Strong understanding of operationalizing clinical development programs in a global setting
• Experience with the implications of protocol design and operational planning on trial execution
• Experience in using data and analytics to inform clinical trial planning and design
• Expertise in clinical data sources and understanding of how and when to apply them
• Experience with tim