Director, Global Program Leader, MAO EMEA

工作内容

Caring for the world… one person at a time” … inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo Director, Global Program Leader, MAO EMEA Position Overview Janssen aspires 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 Program Leader (GPL) to be accountable for the strategic and operational leadership of the EMEA regional Immunology portfolio driven by Global Medical Affairs (GMA), Cross-Regional Medical Affairs studies, and studies where MAO support is needed from global functions e.g. R&D, Epidemiology and the Established Products teams. Reporting to the Global Operations Head (GOH) MAO EMEA, the GPL is accountable for the successful operational planning, set-up, execution and reporting of data generation activities within the assigned therapeutic areas (TAs). This includes adequate resource planning and allocation; meeting deliverables 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. The GPL acts as the single point of end-to-end accountability within MAO for their assigned TAs where they will manage relationships with global, regional and local Medical Affairs teams and other internal trial sponsors, as well as with other external suppliers and enterprise sectors, as applicable. The GPL will lead a team of Global Trial Leaders (GTLs) and G-Clinical Trial Assistants (G-CTA). Along with line management responsibilities, the GPL is accountable for managing and developing staff within his/her scope of responsibility to meet enterprise-wide leadership standards for current and future employment opportunities while fostering a diverse work force that works seamlessly in a highly matrixed environment. Principal Responsibilities Single point of end-to-end accountability for the assigned portfolio/programs Acquires and sustains advanced knowledge of the appropriate Therapeutic Area, product and project setting. Evaluates operational implications of clinical development plans and study design when appropriate. Drives the planning, start-up, execution, and close-out of assigned portfolio/programs: Aligns on project strategy with the Medical Affairs teams and other key stakeholders. Provides operational input in the design and implementation of projects. Discusses strategies including sourcing decisions and key operational questions with the GOH, as appropriate. Ensures critical operational elements are available in a timely fashion to allow optimal project preparation where applicable. Ensures effective budget management for all projects. Partner with the Functional Planning group for project related milestones and adequate resources. Ensures accurate trial budget management and reconciliation of all assigned programs. Drives the Request for Service (RFS) process; partnering with key functions in the preparation and assumptions that make up the RFS. Ensures that all project objectives are met according to all applicable regulations, legislations, guidelines and internal procedural documents. Ensures timely status updates on project deliverables are provided to the Medical Affairs Teams, R&D and other internal trial sponsors and/or other enterprise sectors, as applicable. Identifies and proactively manages issues and risks, communicating in a timely manner with the GOH. Works with relevant project stakeholders and study teams on solutions. Makes recommendations and aligns with the GOH on action plans. Manages and supports training and development needs of direct reports to meet the enterprise-wide leadership standards for current and future employment opportunities while valuing a diverse work force. Monitors resource availability and ensure operational consistency across all projects. Provides recommendations to GOH on people management in line with project execution strategies. Promotes optimal proactive communication between GTLs/TMs/G-CTAs, and with GD functions, project sponsors and key internal stakeholders Establishes strong relationships with the GOH and other Global Program Leaders within GD across all regions and Therapeutic Areas. Contributes to the design, development, and evaluation of the Clinical Operations processes and standards. Qualifications Bachelor’s Degree or equivalent required. Advanced Degree in a scientific discipline and/or master’s degree is preferred. At least 10 years professional experience in clinical research within a pharmaceutical company and/or a Clinical Research Organization Expertise in the areas of drug development, clinical operations, strategic planning, and in-depth knowledge of Medical Affairs. Good understanding of the Immunology therapeutic area is preferred. Effective leadership and proven ability to foster team productivity and cohesiveness. Great understanding of all operational aspects when running large scale multi-regional company-sponsored interventional clinical trials and/or non-interventional real-world evidence data generation activities. Experience in managing and mentoring clinical operations team members. Excellent people leadership skills in a matrix environment are required, people management experience is strongly preferred. Sound clinical financial acumen and experience with managing budgets is required. Effective issue resolution and ability to generate and implement contingency plans for both productivity and quality issues when required In addition, the following competencies/requirements are required to be considered further: Trusted, inclusive, leader with demonstrated experience in managing/mentoring global, cross functional matrix teams and a proven ability to foster team productivity and cohesiveness. Ability to provide strategic leadership, proven decision-making skills, strong negotiating, conflict resolution and risk management skills. Excellent communication, internal and external stakeholder management, influencing skills and ability to establish strong relationships in a global matrix environment as well as the innate flexibility to work in a rapidly growing and changing environment. Willingness and ability to travel up to 15-20% of the time, defined by business needs. In addition: global mindset and cultural affinity; integrity and Credo based-actions, results and performance driven, sense of urgency, managing complexity and ambiguity, analytical skills, customer orientation balancing the customer needs and business demands Principal Relationships: Internal contacts: GOHs, other GPLs, GTLs, TMs and G-CTAs, Clinical Operations’ Country Heads, Global, Regional and Country Medical Affairs teams, Clinical Development Teams, Clinical Supply Chain, Finance Department, Legal, Procurement, Regulatory, Quality Management & Training group; Study Management Teams, and other Johnson & Johnson enterprise sectors, as applicable. External contacts: external service providers, clinical investigative sites and their research staff. 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. Primary Location Belgium-Antwerp-Beerse- Other Locations Europe/Middle East/Africa-France, Europe/Middle East/Africa-Switzerland-Zug-Zug, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-United Kingdom-England-High Wycombe Organization Janssen Pharmaceutica N.V. (7555) Job Function R&D Requisition ID 2105978236W