Sr Director, Global Head of Analytical Monitoring

Job Description - Sr Director, Global Head of Analytical Monitoring (2506232094W)

Sr Director, Global Head of Analytical Monitoring - 2506232094W

Description

Janssen Integrated Data Analytics and Reporting (IDAR) is recruiting for a Sr. Director, Cross-TA Data Management and Central Monitoring, located in either the US (Spring House, PA, Titusville, NJ, or Raritan, NJ), Beerse, Belgium or Switzerland.

The Senior Director, Data Management and Central Monitoring (DM&CM) is a highly experienced and influential leader with expert knowledge of Clinical Data Management and Central Monitoring strategic concepts and processes. This position is accountable for the strategic and operational leadership of DM&CM activities across one or more Therapeutic or Functional Areas, with organizational scope and demand >100 FTEs or equivalent budget across geographic regions.

This role requires a well-established leader, with a recognized track record of substantial organizational development and leadership, assuring efficient production and quality of all DM&CM deliverables. This role has independent decision-making authority for decisions that could have significant/long-term impact on the direction and effectiveness of the DM&CM organization.

The Senior Director DM&CM is accountable for the management, development, recruitment and training of employees within the departmental scope, including Director level roles, to meet current and future business needs.

This position reports to the Head of DM&CM and is expected to be capable of representing DM&CM and Integrated Data Analytics and Reporting (IDAR) in a leadership capacity. The role requires strong partnership and close collaboration with senior functional and matrix leaders across the JRD organization to ensure the successful, efficient, high-quality and compliant delivery for a significant portfolio area.

• Key member of the DM&CM Senior Leadership Team with accountability for large Therapeutic Area(s) portfolio within DM&CM (leadership span DM&CM demand of >100 FTEs or equivalent budget across geographic regions).
• Responsibility for functional TA(s) leadership with high material impact for company in strong competitive landscape. Needs to navigate challenging and complex organizational structure in TA(s).
• Strategic leadership accountabilities include driving the development of capabilities and shaping organizational structures across a large and complex functional portfolio and/or the role's geographical scope.
• Provides exceptional leadership to employees within responsible areas. Leads coaching and development of employees, including Director level individuals across the function.
• Able to represent department in cross-functional discussions and step-in for Head of DM&CM as needed, including on IDAR SLT. Lead discussions with senior R&D colleagues to strengthen coordination between cross-functional and cross-sector departments. This position has direct interface with senior stakeholders and influencers across JRD including TA and Functional Leaders in GD, Clinical, GRA, GMS, BRQC, Planning and Finance.
• Aligns with Business, Functional, and TA Heads/teams on key portfolio objectives and priorities to develop and influence the strategy and direction of DM&CM. Interacts with IDAR and GD colleagues, therapeutic or functional area leaders to execute on the organizational priorities, with a focus on quality DM&CM deliverables.
• Excellent organizational ability to manage DM&CM workload (incl across TAs) and ensure appropriate resource allocation is in place for optimal portfolio support. High level of vendor engagement/utilization with potential to impact and drive vendor capacity due to span of portfolio demand.
• Decision-making has significant/long-term impact on the direction and effectiveness of the functional and/or regional organization due to the large scope and span of area of responsibility. Build Data Management/Central Monitoring teams in new locations/areas as needed to augment development.
• Leader in continuous development and adjustment of innovative operating models. Able to lead, inspire and influence large team/organization through rapidly changing business challenges.
• Provide a leadership role in department process development and optimization of related clinical research activities. Sponsors/leads initiatives with impact to drive change within and across functions and sectors.
• Drives cross-functional senior leadership engagement to develop and deliver solutions for new service capabilities.
• Works with Head of DM&CM to ensure the department strategy and processes are clear towards all stakeholders with optimal communication and engagement. Align processes and priorities to maximize organizational effectiveness; designs and implements innovative approaches to enhance productivity and effectiveness.
• Externally leading and sought-after for insights and functional expertise from across industry; able to represent Janssen in data management, risk based monitoring and other related capacities. Helps establish and maintain Janssen DM&CM as an industry leader.
• Contributes to development and analysis of performance metrics and identifies ways to raise department standards. Responsible for team adherence to standards and compliance.
• Provides leadership by attracting and retaining top talent, developing team members, and ensuring organizational effectiveness, transparency, and communication. The position is responsible to create an environment where employees feel engaged and empowered, and take pride in their roles, responsibilities, and deliverables.
• Strong customer focus and belief in Credo values; creates a positive Credo-based work environment for the DM&CM department.

This position reports to the Global Head of DM&CM.

Internal relationships:

Regular and direct engagement with Senior Heads and Matrix Leaders from Janssen Therapeutic and Functional Areas including: Clinical (Therapeutic Area Heads), Delivery Units, Integrated Data Analytics and Reporting, Statistics and Decision Sciences, Janssen Clinical Innovations, Data Sciences, Bio Research Quality & Compliance, Global Clinical Operations, Medical Affairs Operations, Global Medical Safety, Global Regulatory Affairs and Operations, Human Resources, Talent Acquisition, Finance, IT, Janssen R&D Procurement, External Alliances and Cross-sector counterparts.

External relationships:

Vendor Partners, Consultants, Health Authorities, Professional Societies, Industry Peers and Leaders.

Education:

• A university/college degree in a scientific discipline is required. An advanced degree (e.g., Masters, MBA, MD, PhD) is preferred.

Required:

• A minimum of 15 years' experience in clinical development required with expert knowledge of Data Management and Central Monitoring preferred.
• 5+ years in a senior functional leadership role is required. Demonstrated track record of working within a global matrix environment.
• Extensive people leadership experience including talent development and performance management.
• Excellent understanding of clinical development, quality and regulatory standards (e.g., CDISC) and policies relevant to Data Management and Central Monitoring (e.g., GCP, ICH)

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.