Jobs for People with MS: National MS Society

Role description:

• A global role within Global Development Operations (GDO) based in Ireland

• 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.