Global Operations Head, Managed Access

작업 내용

At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere.

Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.

At Johnson & Johnson we aim to transform lives by bringing life-saving and life-changing solutions to people who need them. Our portfolio of solutions continues to expand, requiring top talent with experience in conducting clinical research across the world.

Medical Affairs Operations (MAO) within Global Development (GD) is recruiting a Global Operations Head (GOH) for Managed Access.

The GOH, reporting to the VP, Global Head MAO is accountable for successful operational strategy, planning and execution of all Managed Access initiatives (Pre-Approval Access and Post-Trial Access programs) within the assigned therapeutic areas (TAs). This includes adequate resource planning and allocation; meeting results within agreed timelines, budget, and with high quality per company procedures and regulatory requirements; as well as driving issue identification and resolution, contingency planning, and decision-making.

In this role, the GOH will manage relationships with global, regional and local Medical Affairs teams, R&D, Patient Strategies & Solutions and other internal program sponsors, as well as with other external suppliers and enterprise sectors, as applicable.

The GOH will lead a team of Global Program Leaders (GPLs), Global Trial Leaders (GTLs), Trial Managers (TMs) and G-Clinical Trial Assistants (G-CTA). Along with line management responsibilities, the GPL is responsible for leading and developing staff within his/her scope of responsibility to meet enterprise-wide leadership standards for current and future employment opportunities while encouraging a diverse work force that works seamlessly in a highly matrixed environment.

Principal Responsibilities

• Be single point of accountability for the operational execution for all managed access requests from start to end. Supervise program progress and resolve critical issues or refer to the appropriate functions.
• The Managed Access Associate Director GCDO Trial Leader (MAc AD GTL) MAO is accountable for the successful planning, execution and reporting of Managed Access initiatives in assigned therapeutic areas (TAs). This includes adequate resource planning and allocation, meeting results within agreed timelines, budget, and with high quality per company procedures and regulatory requirements.
• Ensure all operational activities can be executed in line with company procedures and regulatory requirements, according with global, regional and/or local agreed timelines and within agreed budget.
• Ensure appropriate resourcing to deliver the assigned local, regional and/or global managed access requests.
• Support efficient performance and development of the employees within the department; including clear goals and objectives aligned with the Medical Affairs and R&D G&Os, performance management, training plans, talent and succession planning and employee development plans.
• Provide operational expertise for successful execution of all managed access requests.
• Build and maintain positive relationships with Medical Affairs teams, R&D, Patient Support & Solutions and other internal program sponsors as well as with other business partners and supporting functions at regional, local and global level. Ensure customer focus, the sharing of best practice, and promoting opportunities across the global team.
• Develop and implement strategies for appropriate operationalization of the portfolio and build the relevant expertise within the team.
• Develop sourcing strategies and build trustful partnership with CROs and other key external partners.
• Drive a culture of innovation and continuous improvement to increase customer happiness across the global organization.

Qualifications - External

• Advanced Degree in a scientific field and/or Master Degree is preferred.
• At least 10 years professional experience in clinical studies within a pharmaceutical company and/or a CRO, preferably with Managed Access experience.
• Expertise in the areas of drug development, clinical operations, strategic planning, and in depth knowledge of Medical Affairs, preferably including expertise in Managed Access operations
• Sound clinical financial acumen; experience with running budgets is required. CRO management experience is preferred.
• Effective leadership skills and proven ability to effectively manage stakeholders, develop team productivity and cohesiveness. Excellent interpersonal skills and the innate flexibility to work in a rapidly growing and highly matrixed organization.
• Full understanding of all logistical aspects when running managed access programs regionally and locally, and a good understanding of the therapeutic areas where J&J is involved.
• Demonstrated experience in leading and mentoring clinical operations team members.
• Excellent people leadership skills in a global matrix environment is required.

In addition, the following proficiencies/requirements are required to be considered further:

• Have operated in a sophisticated matrix environment, managing resources, budgets and multiple programs, with demanding timelines.
• Experience in strategic planning, specifically in clinical study operations.
• Knowledge of global and relevant regional or local regulatory requirements related to managed access programs.
• Ability to manage complexity and demonstrate innovative approaches to change management.
• Ability to get along with all levels of management and influence decision-making is required.
• Experience with contributing to the design, development, modification, and evaluation of the Clinical Operations processes and standards to lead improvements.
• Have integrity, be results and performance driven, have a sense of urgency and handle complexity and strong decision making
• Willingness and ability to travel up to 30% of the time, defined by business needs.

Principal Relationships

Internal contacts: VP MAO, other GOHs, GPLs, GTLs and G-CTAs, GCO Country Heads, Regional and Country Medical Affairs teams, Clinical Development Teams, GD functions, The Chief Medical Office, Clinical Supply Chain, Finance Department, Legal, Procurement, Regulatory, Quality Management & Training group; Study Management Teams, and other J&J enterprise sectors, as applicable.

External contacts: external service providers, clinical investigative sites and their research staff.