Director, Clinical Program Operations - US, Remote
US - California - Thousand Oaks - Field/Remote
Career Category
ClinicalJob Description
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youâre part of something bigger, itâs because you are. At Amgen, our shared missionâto serve patientsâdrives all that we do. It is key to our becoming one of the worldâs leading biotechnology companies. We are global collaborators who achieve togetherâresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Itâs time for a career you can be proud of.
Director, Clinical Program Operations
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What you will do
Letâs do this. Letâs 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
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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
Masterâs degree and 8 years life sciences or medically related experience working on clinical trials
OR
Bachelorâs degree and 10 years life sciences or medically related experience working on clinical trials.
In addition to âŚ
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Annual bonus program Career development Career development opportunities Comprehensive employee benefits Comprehensive employee benefits package Financial plans Flexible Spending Accounts Flexible work models Health and welfare plans Life and Disability insurance Professional and personal growth Remote work Retirement and Savings Plan Stock-based long-term incentives Time-off plans Total Rewards Plan Welfare plans
Tasks- Process Improvement
- Resource management
- Study design
Biotechnology Budget management Clinical operations Clinical Research Clinical trials Collaboration Compliance Continuous Improvement Cross-functional Communication Evidence Generation Leadership Operations Process Development Process Improvement R Research Resource Management Resource Planning Risk Assessment Sales Strategy Study Design Team Leadership Teams
Experience10 years
EducationBachelor's Degree DO Doctorate Doctorate degree Life Sciences Master's
Certifications TimezonesAmerica/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9