Early Development Sr. Clinical Trial Manager

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

Early Development Sr. Clinical Trial Manager

Live

What you will do

Let's do this. Let's change the world. In this vital role you will a part of our Global Development Operations (GDO). You will be accountable for the execution, management and reporting of Early Development (ED) clinical trials (phase 0 - 1b) and be a member of one or more cross-functional clinical study teams and a core member of the evidence generating team. These programs focus on the rapid development of emerging New Molecular Entities (NMEs) and require implementation of novel and highly flexible global operational strategies. You will collaborate amongst peers and cross functionally with your clinical study team and evidence generating team.

Early Development Sr. Clinical Trial Managers will work in varying therapeutic areas including hematology/oncology, cardiometabolic, inflammation and healthy volunteer.

Responsibilities:
  • Develop and lead, manage and co-ordinate the operational strategy, risk management, and overall execution of clinical trials
  • Maintain the quality and scientific integrity of clinical trials and communicates global status of clinical trial to senior management as needed
  • Leads the Clinical Study Team to drive effective decision making and encouraging innovative thinking
  • Contributes to the strategic scenario planning in clinical development plan
  • Develops and maintains study timeline and development of clinical protocol and informed consent
  • Contributes to the development and/or review of study-related documentation, including but not limited to monitoring plan, risk management tool, eCRF, manuals, training materials, safety and regulatory documents, and clinical study report, etc.
  • Leads clinical study team to identify, evaluate and select clinical sites
  • Handles the day-to-day operations of clinical trial at a global level and resolves issues escalated by study team
  • Maintains close collaboration with site investigators through regular and ad hoc investigator and site meetings, keeping investigators, often including key thought leaders, engaged to the study
  • Trains study team members and/or sites to conduct the study
  • Leads and coordinates Dose Level Review meetings, communicates decisions of the meetings, and operationalize Dose Level Review meeting outcomes
  • Collaborate with cross functional stakeholders to ensure timely and on budget execution of clinical trial deliverables
  • Support Global Clinical Program Management resource planning for assigned program(s)
  • Support continuous improvement initiatives in GCPM, ED, and GDO
  • Manages vendors and functional service providers (FSP)
  • Line Management of GCTMs / GECDMs


Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Clinical professional we seek is an ambitious leader with these qualifications.

Basic Qualifications:
  • 6+years of experience of clinical research / study management
  • Experience in clinical program management and leading global teams
  • Substantial experience in biotechnology and/or pharmaceutical clinical research with responsibilities for major aspects of strategic planning, organization, implementation, and delivery of clinical programs
  • Bachelor's Degree or equivalent required (scientific or healthcare discipline preferred).


Preferred Qualifications:
  • 8+ years work experience in life sciences or medically related field
  • Minimum 5 years experience in leading global teams
  • Advanced degree in the scientific or healthcare discipline preferred
  • Experience conducting first in human trials and early development study strategy & management
  • Experience with innovative trial designs


THRIVE

You will thrive in this role if you
  • Are driven by AMGEN's mission 'to serve patients' and can inspire others to act
  • Are independent, motivated, team member with the ability to thrive in a matrix environment on multiple projects
  • Can manage multiple stakeholder groups and are able to influence/negotiate
  • Have strong organizational and planning skills


What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
  • This role is based in our Thousand Oaks office with some flexible home working available


APPLY NOW

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

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#GDO2021

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

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