The Director, Data Management and Central Monitoring is a highly experienced leader responsible for functional strategy and delivery for a region, one or more therapeutic or disease areas, and/or strategic innovation programs and projects within Data Management and Central Monitoring.
This position plays a critical leadership role in the Data Management and Central Monitoring organization as a member of the leadership team championing and providing input into the development of departmental strategy policies, procedures, training, and standards.
This position plays a critical role in the growth and development of the department. They contribute to organizational effectiveness, transparency, and communication, while building an inclusive and diverse working environment as a People Manager, through the recruitment, onboarding, performance management, and development of all employees within their organization and/or an expert organizational thought leader driving projects, innovation, and capability growth.
The role requires strong partnership and close collaboration with functional and matrix leaders across the Research and Development organization to ensure the successful, efficient, high-quality, and compliant execution of Data Management and Central Monitoring deliverables.
Principal Responsibilities:· Accountable for the strategy, planning, and execution of departmental deliverables within assigned area and scope ensuring a strong focus on adherence to budget, quality, and compliance standards.
· Ensure alignment with stakeholder and partner functions on Data Management and Central Monitoring strategy closely managing and maintaining collaborative cross department relationships.
· As part of the departmental Leadership Team, contribute to and champion decisions on Data Management and Central Monitoring departmental strategy, priorities, processes, technologies and resources across regions, programs, and projects.
· Proactively evaluate and manage resource demand, allocation, and utilization to meet current and future needs for programs and projects in line with global portfolio and strategic priorities.
· Identify and implement improvement, optimization, and innovation opportunities within data management and/or central monitoring groups and in alignment with departmental standards, strategies, and processes.
· Collaborate and partner with cross-functional leadership to manage issue escalation, resolution, and champion best practices.
· Contribute to development, collection and analysis of performance metrics and identify ways to raise department standards. Ensure adherence of staff and activities with company and department SOPs and policies, and regulatory requirements.
· Provide functional supervision and guide departmental colleagues through consultation, mentoring, and collaborative leadership to build depth of capability.
· Effectively represent and advance the mission of Data Management and Central Monitoring in internal cross-functional/sector level meetings as well as external industry organizations and professional forums.
· Proactively create a purpose driven environment by aligning Johnson Johnson’s Credo and Leadership Imperatives with the strategies and goals of the team and enterprise.
· If people leader, accountable for the management of assigned personnel including local administration, hiring, development, training, performance management, and travel in line with departmental standards and budgets.
Principal Relationships:· Internal (including but not limited to): Data Management and Central Monitoring Senior Leadership Team, peers and staff in Data Management and Central Monitoring, IDAR peers and liaisons in partner functions (inc. Clinical Data Standards and Transparency, Clinical and Statistical Programming, Regulatory, Medical Writing, Business Operations), RD program and study teams (inc. Clinical Leaders), Quantitative Sciences, Global Clinical Operations, Delivery Units, Quality Compliance, Project Management Organization, Regulatory Affairs and Operations, Privacy, Human Resources, Finance, Information Technologies, Procurement, Strategic Partnerships, Cross-sector counterparts.
· External (including but not limited to): External supplier and technology partners, industry peers and working groups.
Position Summary:The Director, Data Management and Central Monitoring is a highly experienced leader responsible for functional strategy and delivery for a region, one or more therapeutic or disease areas, and/or strategic innovation programs and projects within Data Management and Central Monitoring.
This position plays a critical leadership role in the Data Management and Central Monitoring organization as a member of the leadership team championing and providing input into the development of departmental strategy policies, procedures, training, and standards.
This position plays a critical role in the growth and development of the department. They contribute to organizational effectiveness, transparency, and communication, while building an inclusive and diverse working environment as a People Manager, through the recruitment, onboarding, performance management, and development of all employees within their organization and/or an expert organizational thought leader driving projects, innovation, and capability growth.
The role requires strong partnership and close collaboration with functional and matrix leaders across the Research and Development organization to ensure the successful, efficient, high-quality, and compliant execution of Data Management and Central Monitoring deliverables.
Principal Responsibilities:· Accountable for the strategy, planning, and execution of departmental deliverables within assigned area and scope ensuring a strong focus on adherence to budget, quality, and compliance standards.
· Ensure alignment with stakeholder and partner functions on Data Management and Central Monitoring strategy closely managing and maintaining collaborative cross department relationships.
· As part of the departmental Leadership Team, contribute to and champion decisions on Data Management and Central Monitoring departmental strategy, priorities, processes, technologies and resources across regions, programs, and projects.
· Proactively evaluate and manage resource demand, allocation, and utilization to meet current and future needs for programs and projects in line with global portfolio and strategic priorities.
· Identify and implement improvement, optimization, and innovation opportunities within data management and/or central monitoring groups and in alignment with departmental standards, strategies, and processes.
· Collaborate and partner with cross-functional leadership to manage issue escalation, resolution, and champion best practices.
· Contribute to development, collection and analysis of performance metrics and identify ways to raise department standards. Ensure adherence of staff and activities with company and department SOPs and policies, and regulatory requirements.
· Provide functional supervision and guide departmental colleagues through consultation, mentoring, and collaborative leadership to build depth of capability.
· Effectively represent and advance the mission of Data Management and Central Monitoring in internal cross-functional/sector level meetings as well as external industry organizations and professional forums.
· Proactively create a purpose driven environment by aligning Johnson Johnson’s Credo and Leadership Imperatives with the strategies and goals of the team and enterprise.
· If people leader, accountable for the management of assigned personnel including local administration, hiring, development, training, performance management, and travel in line with departmental standards and budgets.
Principal Relationships:· Internal (including but not limited to): Data Management and Central Monitoring Senior Leadership Team, peers and staff in Data Management and Central Monitoring, IDAR peers and liaisons in partner functions (inc. Clinical Data Standards and Transparency, Clinical and Statistical Programming, Regulatory, Medical Writing, Business Operations), RD program and study teams (inc. Clinical Leaders), Quantitative Sciences, Global Clinical Operations, Delivery Units, Quality Compliance, Project Management Organization, Regulatory Affairs and Operations, Privacy, Human Resources, Finance, Information Technologies, Procurement, Strategic Partnerships, Cross-sector counterparts.
· External (including but not limited to): External supplier and technology partners, industry peers and working groups.
• Bachelor's degree (e.g., BS, BA) or equivalent professional experience, preferably in relevant Scientific, Computer Science or Analytics related field. Advanced degree preferred (e.g., Masters, PhD).
• Approx. 10 years years of experience in Pharmaceutical Development or relevant field.
• Expert knowledge of the concepts, processes, and tools, including risk-based approaches and methods in at least one of the following areas: data management, data analytics, and/or central monitoring
• Proven track record of leading teams to successful outcomes with a proven ability to foster team productivity and cohesiveness.
• Established track record working successfully in a complex multi-functional matrix environment partnering with stakeholders, customers, and external vendors.
• Expert knowledge of regulatory guidelines (e.g., ICH-GCP) and clinical RD concepts.
• Applied understanding of project management concepts, sourcing strategies and resource management.
• Proven experience in process development/improvement and/or technology enhancement.
• Excellent influencing and decision-making skills.
• Excellent written and verbal communications skills (in English).
Preferred
• If Principal Responsibilities include people leadership, approx. 5-7 years proven experience in people leadership/management including hiring, talent development and performance management.
• For Analytical Monitoring group:
o Expertise in risk-based monitoring strategies
o Possess proficiency in statistical analysis, data modeling, and data visualization techniques, or demonstrate strong knowledge in these areas.
Other:
• Approx. <10% travel (domestic or international) may be required.
• Bachelor's degree (e.g., BS, BA) or equivalent professional experience, preferably in relevant Scientific, Computer Science or Analytics related field. Advanced degree preferred (e.g., Masters, PhD).
• Approx. 10 years years of experience in Pharmaceutical Development or relevant field.
• Expert knowledge of the concepts, processes, and tools, including risk-based approaches and methods in at least one of the following areas: data management, data analytics, and/or central monitoring
• Proven track record of leading teams to successful outcomes with a proven ability to foster team productivity and cohesiveness.
• Established track record working successfully in a complex multi-functional matrix environment partnering with stakeholders, customers, and external vendors.
• Expert knowledge of regulatory guidelines (e.g., ICH-GCP) and clinical RD concepts.
• Applied understanding of project management concepts, sourcing strategies and resource management.
• Proven experience in process development/improvement and/or technology enhancement.
• Excellent influencing and decision-making skills.
• Excellent written and verbal communications skills (in English).
Preferred
• If Principal Responsibilities include people leadership, approx. 5-7 years proven experience in people leadership/management including hiring, talent development and performance management.
• For Analytical Monitoring group:
o Expertise in risk-based monitoring strategies
o Possess proficiency in statistical analysis, data modeling, and data visualization techniques, or demonstrate strong knowledge in these areas.
Other:
• Approx. <10% travel (domestic or international) may be required.