Senior Director, Head of Global Clinical Process Management

General Description:

The Head of Global Clinical Process Management is responsible for designing, implementing, and optimizing processes across multiple locations or regions. Their role involves analyzing existing processes, identifying areas for improvement, and implementing changes to enhance efficiency and quality. They work on projects ranging from new process development to troubleshooting existing operations, and will collaborate with various teams cross functionally. You will partner with all functions across Clinical Development and Global Process Owners (GPOs) to shape and execute a continuous improvement plan for end-to-end clinical trial processes owned by Global Clinical Operations. This includes monitoring, study management, identifying areas for improvement, designing and implementing process improvements, and leading process improvement teams.

You will be responsible for the assessment, planning, and implementation of global processes, strategies, and solutions for the Clinical Operations organization. In this role you will perform an analysis of current clinical operations processes, systems, and infrastructure including regional considerations to ensure the organization can seamlessly execute global clinical trials across multiple indications in Oncology. You will also provide strategic guidance and oversight of the Global Process Excellence function within Clinical Operations. This role reports into the Clinical Operations Excellence (COE) organization and will be a key leader on the COE Leadership Team, helping to shape the Clinical Operations strategy, and ensuring the vision for process excellence is effectively communicated and implemented.

Essential Functions of the Job:

Strategically lead all efforts related to ensuring clinical operations process excellence

Conduct gap analyses; identify potential risks to clinical operations related to process and inspection readiness; operationalize mitigation strategies in collaboration with key stakeholders/leadership

Strategically evaluate and implement solutions to address any operational geographic gaps related to ensuring clinical operations process team is set up for optimal execution

Optimize current state clinical operations processes and maintain document lifecycle management and continuous process improvements

Develop and communicate future state strategies to clinical operations leadership team

Support organizational change management efforts for Clinical Operations

Provide strategic expertise and facilitate leadership alignment of cross functional SOPs

Effective partnership and collaboration with cross functional leaders/stakeholders (e.g. Clinical Development, Data Management, Quality, Regulatory) as it relates to planning, interdependencies, and risk mitigations for global processes.

Partners with cross functional teams, Global Clinical Operations Global Process Owners to design and implement a clear, well-defined process with clear inputs, outputs, and roles & responsibilities - integrates people, process, and technology components of process design.

Leads Global Clinical Operations process improvement teams/workstreams tasked with re-designing or improving processes including establishing timeline for process improvement projects.

Develops process maps and other process documentation to facilitate the team's analysis and optimization of processes.

Assists Global Clinical Operations, Global Process Owner with change management and implementation of process improvements.

Keep Global Clinical Development key stakeholders and other relevant functions informed of new processes or process updates requiring SOP updates owned by Global Clinical Operations function. Reviews SOPs and training documentation resulting from these new processes or process improvements.

Chair Global Clinical Operations SOP Governance Board. Develop and maintain Governance charter, process.

Monitor key metrics and partners with Global Clinical Operations, Global Process Owner to identify and address gaps/deficiencies.

Works with CRO partners to ensure optimization of key process interfaces to ensure seamless integration of internal and external activities as required.

Works with Global Process Owner to capture and communicate Lessons Learned.

Supervisory Responsibilities:

Develops direct and indirect reports to enhance the business across all areas.

Leads and develops staff, including mentoring, coaching, and performance management.

Computer Skills:

Efficient in Microsoft suite (Excel, Outlook, Word, PowerPoint and Project).

Other Qualifications:

Mid/large pharma experience (preferably clinical operations, process, quality, or compliance roles)

ICH GCP subject matter expert

Knowledgeable of regulatory requirements (e.g., FDA, MHRA/EMA)

Experience working in a cross-functional, global environment

Strong written and verbal communication skills

Deep experience and expertise in end-to-end clinical trial processes including experience in one or more key functions (e.g., clinical research, clinical operations, data management, biostatistics, project management)

Strong leadership, collaboration, and influencing skills in a complex, matrix environment including team leadership or project management

Experience in clinical trial process design, harmonization/optimization, and implementation

Understanding of industry trends (e.g., regulatory, technology) with ability to apply them to process improvement.

Six Sigma certification and/or experience with process mapping tools (e.g., Visio, Power Point) desirable.

Travel: 10-20%

Education Required:

Bachelor's Degree with minimum of 12+ years of experience in pharmaceutical or biotechnology drug development; Master's degree preferred.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.