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J&J Family of Companies Country Head GCO Hungary & Romania in Budapest, Hungary

At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson & Johnson. Please visit www.janssen.com for more information.

Country Head GCO Hungary & Romania

Location: Budapest

We are looking for an inspirational Country Head to lead clinical operational team in Hungary and Romania. As the Country Head you will be responsible for strategic and operational management of Janssen research, development activities and providing leadership. Country head will shape local organizational structure to ensure optimal efficiency. Together with reporting Functional Managers you will manage a team of Local Trial Managers (Local project managers), Site Managers (Clinical Research Associates) and Clinical Trial Assistants, with a strong focus on staff performance, people development, training/onboarding and resource management. You will be a primary point of contact for Health Authority agencies for activities related to clinical operations in related countries. Country head takes the management responsibility for the successful implementation and execution of phase Ib-IIIb trials from country feasibility through study close-out while keeping clear oversight of timelines, budget, quality & performance indicators and compliance with Standard Operating Procedures (SOPs), Health Care Compliance (HCC) and local regulatory requirements. Together with Compliance Manager you will ensure the country compliance with quality and operational metrics and lead regular metrics review and vital follow-up actions. You will shape and maintain strong relationships with GCO organization, Local Operating Company (particularly with Medical Affairs) and may participate in Local Management Board and Regional Management Teams.

We are seeking to hire a strong, visionary leader, who is a standout colleague, with quick learning and problem-solving abilities. You will create and drive the country strategy in order to optimize ways of working, drive innovation, and strive for improvement and future readiness. You will be part of a hardworking, enthusiastic, and committed team eager to deliver and helping to improve the lives of millions of patients.

Principal Responsibilities:

  • Leadership and strategic direction : Define and implement long-term strategy for GCO Hungary and Romania in line with Janssen R&D strategies and drive tactics to full implementation, deliver on country commitments and strategic goals; contribute to shaping environment for clinical trials (e.g. through involvement in pharma industry associations), foster a culture of continuous improvement and innovation.

  • People management : Provide line management to your team including goal setting, performance evaluation and talent development; Build, hire and train a fully effective team; conduct accompanied site visits; Evaluate and forecast resource needs; leads and/or participates in special (global) initiatives as assigned

  • Trial delivery & oversight : Responsible for delivering on country commitments, implementation, execution and monitoring of trials. Deliver on your team's quality and performance objectives. Ensure inspection readiness at all times, adherence to ICH-GCP, local legislation and relevant SOP's. Support your team in issue resolution and stakeholder management. Support audits, inspections and timely CAPA resolution. Build and shape network.

  • Continuous improvement & organizational change: Lead implementation of innovation and change in the local organization; Cultivate an environment that encourages shared learning, out of the box thinking and continuous improvement. Contribute to the development of new processes or initiatives. Keep close oversight of metrics and drive follow-up actions proactively.

Qualifications

We would love to hear from YOU, if you have:

  • Bachelor's degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy). Advanced degree in a scientific discipline and/or Master’s degree is preferred.

  • Minimum of 10 years of clinical research experience acquired in pharmaceutical industry, CRO or investigational site.

  • Excellent communication and leadership skills. Validated ability to foster team productivity and cohesiveness. Ability to manage complexity under pressure. Proven track record of people and project management. Strong in hiring, training, developing and evaluation of leaders and people managers. Strong decision-making and financial management skills. Flexibility to work in a rapidly changing environment with the appropriate sense of urgency. Experience in transforming organizations in response to business needs.

  • Effective issue resolution and ability to generate and implement contingency plans for both productivity and quality issues when required. Excellent knowledge of drug development, clinical research operations and regulatory requirements including ICH-GCP, HCC and applicable regulations. Ability to synthesize and evaluate data generated from various reports and sources. Demonstrated skills in effective communication with various internal and external stakeholders (e.g. investigational sites, ethics committees, health authorities. etc.). Influential in improving the clinical research environment at a country level. Visionary leader who can shape the organizational culture to improve adoption of future state.

  • Operates with limited supervision.

  • Proficiency in English. Computer literacy. Strong interpersonal and negotiating skills. Excellent organizational skills. Perform activities in a timely and accurate manner.

    This is what awaits YOU at J&J:

  • An opportunity to be part of a global market leader.

  • A dynamic and inspiring working environment.

  • Many opportunities to work on challenging projects and assignments.

  • Possibilities for further personal as well as professional development.

  • Many employee benefits.

    For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

    We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences

    That is why we in Johnson & Johnson are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

    Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!

Primary Location

Hungary-Budapest-Budapest-

Organization

Janssen-Cilag Kft. (8396)

Job Function

R&D

Requisition ID

2105987860W

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