J&J Family of Companies Clinical Program Management Leader in Beerse, Belgium
The CPML is accountable to the PMO leadership and the CT Leader to utilize best-in-class Clinical program management support to provide end-to-end oversight of the Clinical program strategy, and management for initiating, planning, executing, controlling, reporting, and terminating the integrated Clinical development plan. As a Co-Leader of the CT, the CPML provides Clinical cross-functional operational and program management leadership for the Clinical programs for therapeutic products or non-interventional healthcare platforms in a global, matrix organization, from NME declaration to life cycle management. CPMLs are guided in all matters by our J&J Credo values and our Leadership Performance Standards.
The CPML works in partnership with the CL (Clinical Leader) to achieve the following results:
Establish the Clinical strategy with concomitant goals and objectives in alignment with the organizational objectives. Contribute to and coordinate Clinical strategy updates over time; provide context and history to new CT members/ stakeholders. Mentor colleagues in CT best practices.
Drive the CT to meet or exceed those goals by providing superior global cross-functional operational leadership and management in a matrix organization, facilitating Clinical issue identification and resolution, problem-solving, risk management, contingency planning and decision-making. The CPML challenges the status quo and leads innovation.
Manage the CT in a manner that fosters and maintains a high performance team culture, and utilize team development best practices and facilitate lessons learned to ensure optimal performance. With the CL, co-chair CT meetings and represent the CT to the Company at governance meetings, co-development partnerships, and external meetings such as Health Authority or Advisory Meetings.
Co-leads the CT. The Clinical Leader/ Global Medical Leader drives strategy, and the CPML leads the team to operationalize that strategy (including scenario planning, stage gate approvals and setting priorities) and optimize the Clinical plans through constructive challenge and continuous dialog with the different functions to ensure all activities are aligned with the Compound Development Team goals and objectives. Th CPML ensures documentation of Clinical team meetings, key decisions, action items and cross functional communication (e.g., SharePoint, Teamworx).
Partner with cross functional leads (TA, GCDO, Statistics, Clinical Pharmacology, Biomarkers, Clinical Supplies, Global Medical Safety, Finance, Regulatory) at the Clinical program level to assure end to end Clinical program oversight; and to identify and mitigate risks and issues in order to maintain quality, timelines, resources and budget.
Collaborate with Clinical Team partners (TA, Medical Writing, RA, etc.) and provide oversight in the design, development and submission of key Clinical documents including the protocol, study reports and appendices. Gain cross-functional alignment to assure that risks are identified, key issues are resolved and the timelines are maintained. Take a lead role in ensuring Clinical readiness for stage gate reviews and governance reviews and decisions.
Partner with the Program Management Leader (PML), Program Coordinator (PC), Finance and the PMT to manage the overall Clinical program planning and budget (FTE + OOP) on an ongoing basis as well as during business plan cycles. Drive integration of the overall Clinical budget with TA, GCDO, CSU and functional representatives. In conjunction with PMO partners, provide input and/or review of periodic reports to management.
If applicable, on co-development programs, work within the Joint Development Team or equivalent to manage and align cross company Clinical research activities and objectives.
In collaboration with the Clinical and regulatory functions, work at the Clinical program level to drive the planning and preparation of Clinical documents required for successful Health Authority submissions, and clinically-related external committees and meetings such as Advisory Boards.
Demonstrate ability to resolve conflict and influence teams without formal authority. Motivate colleagues through personal example, and dedication to team goals. Inspire confidence and build group trust. Use emotional intelligence to spot signals others miss. Keep group focused on strategy and goals despite complexity, controversy, or conflict. Build bridges between organizations; turn adversity into opportunities for change and growth.
Contribute to the success of the PMO in achieving its goals and objectives by ensuring program work is conducted in compliance with PMO processes and Company policies, lead program management process and quality improvement initiatives and other tasks assigned by the PMO leadership team.
Primary duties listed above are not to be construed as exhaustive; other duties may be assigned by the PMO.
A minimum of a B.S. degree is required; and a B.S. degree in a pharmaceutical-related, life sciences, or business subject is preferred.
Professional project management certification or diploma is preferred.
A minimum of 5 years of industry/business experience, including a minimum of 5 years in Clinical R&D, is preferred.
Prior experience as a member of a Clinical cross-functional team is preferred.
A minimum of 3 plus years of experience in project management, Clinical team leadership, and/or Clinical functional line management in areas such as Clinical Trials Management, Biostatistics, Medical Writing, Data Management, Program Management or Regulatory is preferred. Experience in developing a Health Authority dossier is preferred.
Clinical cross-functional experience is preferred. Successful experience managing or leading global and/or virtual teams is preferred, especially if done within a matrix organization.
Record of successful governance body and/or stakeholder management preferred.
Experience in the planning or management of regulatory submissions (e.g., IND/CTA, NDA, MAA, etc.) is preferred.
North America, Europe/Middle East/Africa-Netherlands-South Holland-Leiden
Janssen Pharmaceutica N.V. (7555)