Director, Clinical Program Operations - US, Remote

Career Category

Job Description

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.

Director, Clinical Program Operations

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will be responsible for the planning, delivery and evaluation of clinical programs on a global scale and ensure the clinical programs align with strategic goals and are conducted in compliance with relevant regulations.

This is the Global single point of accountability for operational strategy, planning, risk assessment and mitigation, and overall delivery of clinical trial programs. This role supports continuous improvement initiatives in CPO and throughout Global Development Operations (GDO)

Responsible for:

• Global clinical program operational strategy, planning, risk assessment and mitigation, and overall delivery
• High-quality delivery of clinical trials on time and within budget
• Leadership of the Global Clinical Studies Team (GCST) for the allocated program(s)
• Providing clinical operations leadership and expertise on the Evidence Generation Team and in development of the Evidence Generation Plan (EGP) and PT as required
• Providing clinical operations leadership and expertise in EGP delivery through the feasibility and study design process
• Development and oversight of clinical program budgets in collaboration w ith TA and Finance
• Managing program-level operational issues and oversight of study team issue escalation
• 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)
• Line management of CPO CPM-SMs / ADs

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The medical life sciences professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

Doctorate degree and 4 years life sciences or medically related experience working on clinical trials

OR

Master’s degree and 8 years life sciences or medically related experience working on clinical trials

OR

Bachelor’s degree and 10 years life sciences or medically related experience working on clinical trials.

In addition to meeting at least one of the above requirements, you must have at least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

• PhD, PharmD, MSc., B.Sc., R.N
• 11 years work experience in life sciences or medically related field, including 8 years of biopharmaceutical 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.)

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $192,437.00 to $229,790.00. Actual salary will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A dis