Head, Data Management

Position Summary:

• An influential leader with advanced understanding of the drug development process, with significant experience in overseeing clinical data management activities and assuring efficient production and quality of all data management deliverables for all areas of Clinical Research. 
• A well established leader, with a recognized track record of organizational development and leadership, driving all aspects of the data management discipline leading to effective and efficient delivery of the Janssen portfolio across multiple therapeutic areas and all phases of development.
• Provide a leadership role in department process development and optimization of related clinical research activities.
• Accountable for the development of all employees within the department including management development and training to meet current and future business needs.  Provide an environment, which encourages the company's commitment to equal employment opportunity and the value of a diverse work force.

Principal Responsibilities:

• Define vision and lead the data management function by providing technical and business leadership
• Accountable for operational delivery, quality, compliance and timelines of data management for all areas of supporting the Janssen R&D portfolio.
• Ensures departmental policies, training, standards, and systems are adequate to support drug development for regulatory approval. Be accountable for full compliance to all regulatory requirements
• Promote and ensure partnership with partner functions at all levels to ensure seamless collaboration on the projects for all deliverables and enable innovation and strategic input through providing high-end data management solutions
• Build and deploy innovative solutions, enhancing effectiveness and efficiency of the data management organization.
• Drives business efficiency, financial planning and cost basis; Stay current, anticipate internal and external drivers and opportunities to devise and implement cross-functional strategies to maximize productivity and efficiency through use of effective business process, global corporate standards, development and utilization of strategic alliances with external partners to ensure high quality operational and strategic management of the global data management function
• Provides leadership to the data management team by attracting and retaining top talent, developing team members, and ensuring organizational effectiveness, transparency, and communication; establishing the Janssen data management team as an industry leader
• Develop and implement functional excellence for data management by defining strategic goals and sponsoring/leading the associated initiatives. Communicate with IDAR SLT and ensure that initiatives’ objectives and priorities are in line with IDAR and Global Development strategy.
• Partner with peer functions to drive end to end standardization and process simplification.
• Accountable for departmental policies, procedures, training and standards. 
• Policy and standards development and compliance as it relates to delivery of data management
• Participates in and/or lead cross-functional and cross-company initiatives, as applicable.

Responsibility for others:

This position reports to Head IDAR. The job holder will be expected to provide leadership to the data management organizations’ teams by attracting and retaining top talent, developing team members, and ensuring organizational effectiveness, transparency, and communication.

This position is responsible for a team of more than 400 Janssen employees globally, in addition to significant external support based on portfolio and project demands.

• Provide effective leadership to his/her team members responsible for supporting the Janssen R&D portfolio of clinical studies.
• Set team goals and objectives, periodic performance evaluation and feedback, and the development of all employees within functional scope
• Ensure compliance with department SOP’s, WI’s, policies and regulatory guidance documents and all associated trainings
• Provide an environment, which encourages the company's commitment to equal employment opportunity and the value of a diverse work force.
• Regularly meet with team members at all levels to ensure appropriate progress within functional scope.
• Estimate required budget covering Capex, Opex and Resource needs and effectively manage same.

ADDITIONAL RESPONSIBILITIES:

• Participates in IDAR, GD, and R&D initiatives as assigned.
• Regularly meets with direct reports to ensure consistency and appropriate progress towards project goals.

Collaborates and partners with cross-functional leadership to drive issue escalation and issue resolution, and champion best practices.

Qualifications

Education and experience requirements:

• University/college degree is required.
• An advanced degree (e.g. Masters, MBA, MD, PhD) is preferred.
• 15+ years industry experience (or equivalent breadth of Pharmaceutical experience)
• 5+ years of experience in a senior managerial position leading people is required.
• Proven people leadership capabilities
• Excellent understanding of clinical development, quality and regulatory standards and policies relevant to data management (e.g. GCP, ICH)
• Advanced expertise in data management principles, CDISC standards is required.

Other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.

• The job holder will have a proven ability to lead, manage and develop a high functioning diverse team and to build a department to enable industry-leading data management capabilities.
• The jobholder will have scientific, technical and business expertise and significant experience gained through working with diverse and complex business processes and technology.
• A thorough understanding of clinical research processes is required with demonstrated expertise in deploying data management solutions supported by technology.
• Well-established track record and sought after across the industry for strong data management science and organizational leadership. Proven ability to effectively lead major non-clinical initiatives requiring data management expertise
• Provide thought-leading insights to the competitive environment and internal partner interfaces
• Outstanding skills to facilitate/optimize contribution of team members as individuals and members of cohesive team
• Proven track record in working across a matrix organization and demonstrates expert skills in building partnerships, negotiating agreements; excels at collaboration
• Excellent interpersonal and communication skills, able to naturally bridge scientific and business participants; Track record in enabling effective international collaboration
• Drug development expert in R&D encompassing planning, execution, reporting and regulatory requirements in readiness for submissions and commercialization
• Ability to manage high workload and critical issues in a timely matter
• Outstanding verbal and written communications

Primary Location
United States-Pennsylvania-Spring House-
Other Locations
Europe/Middle East/Africa-Netherlands-South Holland-Leiden, North America-United States-New Jersey-Titusville, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, Europe/Middle East/Africa-Switzerland-Allschwil, United States-Pennsylvania-Spring House
Organization
Janssen Research & Development, LLC (6084)
Job Function
R&D
Requisition ID
0062200303