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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