Clinical Program Management Director

Job title: Clinical Program Management Director

Company: Amgen


Job description: Career Category Clinical DevelopmentJob DescriptionRole description:

• A global role within Global Development Operations (GDO) based at either US or UK GDO management locations
• Reports (at a minimum) to: CPO TA Head.

Responsible for:

• 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
• Providing 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)
• Line management of CPO CPM-SMs / ADs

Purpose / Accountabilities

• Global single point of accountability for operational strategy, planning, risk assessment and mitigation, and overall execution of clinical trial programs
• Support continuous improvement initiatives in CPO and throughout Global Development Operations (GDO)

Key Activities

• 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.

Qualifications
Basic Qualifications

• Doctorate degree & 4 years of directly related experience or equivalent

OR

• Master’s degree & 8 years of directly related experience or equivalent

OR

• Bachelor’s degree & 10 years of directly related experience or equivalent

AND

• 4 years of direct managerial and/or leadership experience or equivalent

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.)

Knowledge

• 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
• Relevant operational expertise
• 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
• Experience in leading organizations through change
• Relevant therapeutic knowledge.

Key Competencies

• Departmental Leadership
• People Management
• Project Management
• Matrix team leadership
• Strategic Operational Planning
• Relationship Management and negotiation and influencing skills
• Risk assessment/ risk mitigation
• Innovation
• Decision Making and Problem Solving
• Conflict Management
• Oral and Written Communication
• Scientific / Technical Excellence
• Financial Management
• Flexibility / Adaptability.

.

Expected salary:

Location: Dublin

Job date: Sat, 01 Feb 2025 07:11:32 GMT

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