Senior Director, Clinical Program Operations

at  Amgen

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. Join us.

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.
You will also support continuous improvement initiatives in Clinical Program Operations (CPO) and throughout Global Development Operations (GDO)

Responsibilities:

• Global clinical program operational strategy, planning, risk assessment and mitigation, and overall execution
• High-quality execution 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
• Provide clinical operations leadership and expertise in EGP execution through the feasibility and study design process
• Development and oversight of clinical program budgets in collaboration with 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)

Key activities:

• Line management of CPO CPM-SMs / ADs
• Oversee the operational design, planning and execution of all studies for the program
• Oversee the development of timelines and budgets for studies within the program
• Oversee people management, career development, training and succession planning of CPO Senior Managers and Associate Directors
• Oversee structure and engagement of program CPO team
• Input into product Clinical Development Planning (CDP) and evidence generation plans
• Initiate and support conduct of Country Operational Landscape Assessments and study feasibility with Development Feasibility Senior Managers
• Contribute operational expertise throughout study design coordinating cross functional input on a continuous basis
• Provide advice on development of Key Design Elements (KDE) prior to Governance Body review
• Provide visibility to study cost drivers and assumptions as refined throughout KDE and protocol development
• Lead cross-functional team to create and periodically review/revise program & study Clinical Trial-Risk Assessment Categorization Tool (CT-RACT)
• Evaluate if “Patient Voice” techniques should be incorporated on program and design, implement and measure the success of subject Recruitment and Retention Strategies
• Accountable for study global enrolment plans, revised enrolment plans and accurate global recruitment forecasting
• Support the resolution of cross-functional program issues escalated from the study teams and GCST and inform / escalate to TA Head and other stakeholders as appropriate
• Leads the GCST to ensure operational consistency and standards across all clinical studies within the program
• Communicate effectively with key stakeholders the program strategy and deliverables
• Contribute to functional goal setting
• Facilitate sharing of best practices, product knowledge and identify areas for process improvement within CPO
• Review vendor evaluation to include identification of outsourcing requirements for study / program and oversee management of vendors.
• Supports and oversees internal audit and inspection activities and contributes to CAPAs globally for the program
• Lead planning for regulatory agency inspection readiness activities (e.g. TMF review) and ensure execution of plans
• 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