Scientist Scientific/Technical Operations Clinical Pharmacology 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.

Scientist Scientific/Technical Operations Clinical Pharmacology Job Description

The Clinical Pharmacology small molecules (ClinPharm) department is recruiting for a ClinPharm Scientist/Senior Scientist with demonstrated leadership for the development and execution of clinical pharmacology (pharmacokinetic [PK] and pharmacodynamic [PD]) activities related to the research, design, implementation, data analysis, interpretation, reporting, and publication of ClinPharm-initiated and -supported studies for products in any phase of development. This position is based in Beerse and reports to the Regional Head of ClinPharm Scientific-Technical Operations (STO). The ClinPharm Scientist position is open to all internal candidates and is in Pay Grade 26 or 30.

Job Function: In conjunction with STO management, ClinPharm Therapeutic Area Heads and ClinPharm Leaders, in support of assigned development project(s), this position is accountable for:

• Assisting the ClinPharm Leader in the overall ClinPharm development strategy, the design of specific ClinPharm Phase 1 studies including the design of ClinPharm assessments within clinical Phase 2/3 studies
• Participates actively in the ClinPharm Working Group and interacts with Clinical Team members to ensure that the ClinPharm program and study-related scientific issues are addressed and resolved
• Develops/writes/reviews ClinPharm sections in clinical trial protocols. Coordinates the overall development of (Phase 1) ClinPharm protocols utilizing current templates. Assists ClinPharm Leader in the defence of the synopsis and protocols at Synopsis Review Committee (SRC) and Protocol Review Committee (PRC) meetings
• In collaboration with the ClinPharm Leader and Modelling Scientist (as needed), applies state-of-the-art tools for PK and PK/PD analysis or, when appropriate, contribute to specialized analyses, such as allometric scaling, IVIVC, and PB/PK analysis
• In alignment with the ClinPharm Leader and on an as-needed basis, participates in scientific working groups with cross-functional/cross-departmental scope, such as Clinical Team, Dossier Team and other project-related meetings, to provide input regarding project or submission deliverables; e.g., Clinical Study Reports (CSR), Common Technical Document modules, briefing books for regulatory meetings, etc.
• Collaborates, when applicable, with the ClinPharm Leader and ClinPharm Program Manager in the evaluation of Contract Research Organization (CRO) capabilities. Assists and supports in the evaluation, selection, and training/education of study site and/or personnel for PK studies in conjunction with J&JPRD business parts.

Scientist Scientific/Technical Operations Clinical Pharmacology Job Requirements

What does Johnson & Johnson require of a Scientist Scientific/Technical Operations Clinical Pharmacology:

• BS Degree or equivalent: at least 3 years of relevant industry experience; MS/PharmD/PhD Degree: al least 1 year of relevant experience
• A track record of successful global collaborations and partnerships in a culturally diverse environment
• A fundamental understanding of GCP and other relevant regulatory guidelines and regulations
• Proficiency in WinNonlin/Phoenix is required, and good general computer skills and proficient in MS Excel, PowerPoint, Word is required.
• A fundamental understanding of clinical PK & PK/PD concepts and clinical drug development
• Very good verbal and written English communication skills; Dutch language skills are an asset
• Demonstrated motivation, teamwork ability, strong problem-solving ability and communication skills are required
• Demonstrated scientific excellence through publications, meeting abstracts and/or presentations are preferred
   

Scientist Scientific/Technical Operations Clinical Pharmacology Application Information

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Scientist Scientific/Technical Operations Clinical Pharmacology Summary

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