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Director of Planning

4 months ago


Uxbridge Greater London, United Kingdom EcoPlanet Green Operations GmbH Full time

Senior Director, Clinical Program Operations in Uxbridge , United Kingdom HOW MIGHT YOU DEFY IMAGINATION?
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. SENIOR DIRECTOR, CLINICAL PROGRAM OPERATIONS
In this vital role you will lead and have global accountability for operational strategy, planning, risk assessment and mitigation, and overall execution of clinical trial programs in Amgen's Obesity organisation.
Global clinical program operational strategy, planning, risk assessment and mitigation, and overall execution
High-quality execution of clinical trials on time and within budget
Providing clinical operations leadership and expertise on the Evidence Generation Team and in development of the Evidence Generation Plan (EGP) and PT as required
Maintaining global business relationships cross-functionally and communicating global status of clinical trial programs to senior management
Support CPO resource planning for assigned program(s) in collaboration with Program Resource Management (PRM)
Line management of CPO CPM-SMs / ADs
Oversee people management, career development, training and succession planning of CPO Senior Managers and Associate Directors
Initiate and support conduct of Country Operational Landscape Assessments and study feasibility with Development Feasibility Senior Managers
Lead cross-functional team to create and periodically review/revise program & study Clinical Trial-Risk Assessment Categorization Tool (CT-RACT)
Review vendor evaluation to include identification of outsourcing requirements for study / program and oversee management of vendors.
Lead planning for regulatory agency inspection readiness activities (e.g. Represent the function by contributing and / or leading initiatives for the continuous improvement of clinical trial planning and execution. Contribute to development and maintenance of policies, SOPs and associated documents
Oversee the development of study diversity plans and ensure program actively engaging in DI&B strategies
Degree educated, PhD, PharmD, MSc., Proven experience in life sciences or medically related field including 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
Knowledge of global regulatory requirements and guidelines for conducting clinical research and safety monitoring / reporting
Project and Program management including oversight of study deliverables, budgets and timelines
Time, cost and quality metrics
Understanding of resource management and organizational capacity management
Experience in developing goals and training plans to maximize talent and career development of staff
Experience of managing projects in a matrix organization
Ability to network and build relationships to maximize organizational and functional capabilities
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.
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
LOCATION Ability to work fully remote, or, if situated near an office, the option to work flexibly from home with occasional office presence at our Cambridge or Uxbridge next-generation workspace.
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
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