Head, Clinical Data Standards
An influential leader with advanced understanding of the drug development process, with significant experience in governing and overseeing the creation and implementation of clinical data standards activities.
A well established leader, with a recognized track record of organizational development and leadership, driving all aspects of clinical data standards from protocol development through to reporting, with a predominant focus on strategic and technical leadership, translating the strategy into a robust implementation plan, executing against the plan globally, and monitoring successful implementation through metrics and a robust governance model.
Provide a leadership role in department process development and optimization of related data standards 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.
Define vision and lead the clinical data standards function by providing technical and business leadership
Accountable for developing, deploying and maintaining clinical data standards in support of the Janssen pharmaceutical portfolio of products specifically within Janssen R&D scope, driving data quality and consistency within and across line functions
Champion development and implementation of clinical data standards, ensuring effective communicaton and collaboration among the standards and other functional groups impacted by standards. This includes but is not limited to training on new standards, impact analysis of changes in standards, including the impact on submissions
Provide functional expertise in the area of Data standards, and remain current in the latest technologies supporting clinical data standards.
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
Provide leadership in broad scale deployment of end-to-end standards and demonstrate business value in terms of increased compliance and reduction in cycle time and cost. In support of driving business value related to investment in clinical data standards, develop and manage metrics covering development, maintenance, adoption and associated value (time, cost, quality & customer).
Lead the data governance process to ensure consistent data standardization across development, ensuring a robust standards adherence process, balanced vis--vis the needs of clinical research to deliver the highest business value.
The job holder will provide subject matter expertise as well as required resources in support of J&J Enterprise initiatives that require clinical data standards.
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 clinical data stnadards function
Provides leadership to the clinical data standards team by attracting and retaining top talent, developing team members, and ensuring organizational effectiveness, transparency, and communication; establishing the Janssen clinical data standards team as an industry leader
Develop and implement functional excellence for clinical data standards 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 clinical data standards
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 standards 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 20 Janssen employees globally, in addition to external support based on portfolio and project demands.
The job holder will be expected to:
Provide effective leadership to his/her team members responsible for the development, deployment and maintenance of data standards 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.
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.
Education and experience requirements:
University/college degree is required.
An advanced degree (e.g. Masters, MBA, MD, PhD) is preferred.
12+ 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 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 standards 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 standards solutions supported by technology.
Well-established track record and sought after across the industry for strong data standards and organizational leadership. Proven ability to effectively lead major non-clinical initiatives requiring data standards 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
Ability to manage high workload and critical issues in a timely matter
Outstanding verbal and written communications
United States-New Jersey-Raritan-
Europe/Middle East/Africa-United Kingdom-England-High Wycombe, Europe/Middle East/Africa-Switzerland-Allschwil, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, North America-United States-Florida-Titusville, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Janssen Research & Development, LLC (6084)
Johnson & Johnson