Regional Head, Scientific Technical Operations Job in Beerse, Belgium

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.

Our Family of Companies comprises:
The world’s sixth-largest consumer health company
The world’s largest and most diverse medical devices and diagnostics company
The world’s fifth-largest biologics company
And the world’s eighth-largest pharmaceuticals company
We have more than 275 operating companies in more than 60 countries employing nearly 128, 000 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.

Regional Head, Scientific Technical Operations Job Description

The Clinical Pharmacology department is a Center of Expertise within the Quantitative Sciences organization in R&D Operations at Janssen Research & Development. Our vision is to ”create and use state of the art science and knowledge to develop highly differentiated products more effectively and to optimize benefit-risk by delivering the right dose to the right patient”.

The group is responsible for the clinical pharmacology contributions to all small-molecule products in all stages of development and to marketed products within the Janssen product portfolio. In addition to functional excellence in clinical pharmacology sciences, quality & compliance and diversity & development of our staff also high ethical standards and continuous business process improvement are key areas of focus. We partner closely with our peers in the Biological’s Clinical Pharmacology group and the Janssen clinical pharmacology groups in Japan and China.

Within Clinical Pharmacology the global Scientific Technical Operations (STO) group integrates Clinical Pharmacology Scientists, Associate Scientists, Program Managers, Process Support Specialists and Administrative Associates based in Jolla, Titusville, Raritan and Beerse into one single group, with one global leader. The STO group is accountable for the operational execution of Clinical Pharmacology activities included in agreed product development plans and for providing scientific/technical and operational contributions to TA strategies/plans, product development plans, clinical trial designs, protocols, reports and regulatory documents on time, with appropriate quality and within budget. The group partners very closely with the Therapeutic Area-aligned groups of Clinical Pharmacology Leaders, and with colleagues in the Model Based Drug Development and Biometrics & Reporting departments.

The STO group is now recruiting for a Regional Head, Scientific Technical Operations, based in Belgium.

Your function:

You manage the regional Clinical Pharmacology Scientific-Technical Operations group of approximately 10 to 15 scientific, technical, professional and administrative staff to ensure that assigned deliverables, milestones and activities included in agreed product development plans for products in early-stage, late-stage and post-marketing development are delivered on time and with appropriate quality. You oversee work that is outsourced to strategic and nice providers and you facilitate the application of clinical pharmacology science in the development programs.

You are responsible for efficient and effective execution of assigned work and for compliance with regulatory and legal requirements and with company SOPs, Guidelines and work instructions. You are accountable for the quality of activities and deliverables of the regional group and will co-drive continuous improvement in departmental process and systems to ensure efficiency, effectiveness and operational excellence.

You will ensure recruitment, development, career progression and retention of staff, stimulate innovation in clinical pharmacology and the application of model-based drug development tools, and stimulate and facilitate scientific and professional development of the group and of individual staff members.

Key accountabilities of the function:

• Manage and provide leadership to the regional STO group to ensure the operational execution of assigned activities and completion of agreed deliverables on time;
• Ensure the scientific, technical and operational quality of the deliverables (trial designs, protocols, reports and regulatory documents);
• Ensure compliance of the regional STO group with regulatory and legal requirements and with company SOPs and work instructions;
• Maintain seamless collaboration across regional STO groups to ensure integrated workload and resource planning, sharing and distributing work as required, and act as one single STO group towards internal stakeholders and external service providers;
• Provide leadership and direction in developing, improving and implementing processes and tools to ensure and enhance the department’s efficiency and effectiveness.
• Participate in and/or act as back-up of the global STO Head in functional review and governance activities, as applicable.
• Recruit, develop and retain a diverse workforce of scientific, technical, professional and administrative staff in the regional STO and global ClinPharm group;
• Mentor, guide and ensure scientific training of staff within the STO group.
• Promote innovation, creativity, and application of MBDD tools and stimulate staff to pursue new scientific endeavors and professional career progression.
• Effective and Credo-based performance management of employees in compliance with applicable regulations and company policies.
• Promote company standards for ethical, legal and credo-based behavior of associates and hold employees accountable to these standards.

Regional Head, Scientific Technical Operations Job Requirements

What does Johnson & Johnson require of a Regional Head, Scientific Technical Operations:
 

• MSc or Pharm D, or equivalent through education and experience, with at least 7 years relevant postgraduate experience in the drug industry.
• At least 3 years’ experience in managing groups of up scientific professionals.
• Good understanding of clinical pharmacokinetics, pharmacology, pharmacodynamics, and modeling & simulation.
• Good understanding of clinical drug development and the overall pharmaceutical R&D process.
• Understanding of the principles of GLP, GCP, and of the principles of quality management.
• Understanding of the application of PK/ADME software tools, data management and visualization tools, and other tools used in model-based Drug development.
• Understanding of US and European regulatory processes and systems.
• Fluent in written and spoken English.
• Ability and willingness to travel (<10% of the time) and partially adjust work hours to facilitate trans-Atlantic collaboration.

Regional Head, Scientific Technical Operations Application Information

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Regional Head, Scientific Technical Operations Summary

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