Scientific Director - Pharmacometrics
Location: Beerse, Belgium
At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating diseases of our time.
We have an exciting opportunity for a Scientific Director, Pharmacometrics, located within commutable distance of Beerse, Belgium within our Clinical Pharmacology & Pharmacometrics team. The Scientific Director Pharmacometrics position is responsible for strategizing the development and execution of population pharmacokinetics [PK] and pharmacodynamic [PD] modeling and simulation activities related to the study design, data analysis, interpretation, reporting and publication for products in any phase of clinical development. Additional responsibilities include the generation and review of PK/PD documents related to regulatory submissions, preparing responses to Agency questions and preparing for and/or attending meetings with Regulatory Agencies or Advisory Committee Meetings. The position is responsible for supervising and conducting advanced population PK-PD modeling and simulation exercises, and independently contributing to drug development and the advancement of pharmacometric science both internally and externally.
Are you interested to join our team? Then please read further!
Main Accountabilities
Independently:

• Strategize, prioritize, coordinate and contribute to the Pharmacometrics workload for projects in the TA as needed.
• Conducts advanced PK/PD modeling and simulation research with emphasis on mechanism based modeling techniques and disease progression models.
• Supports product development by defining dose-concentration-pharmacological effect relationships of a drug using modeling & simulation methodologies from data acquired at various clinical development stages (Phase 1-3).
• Performs population PK/PD analyses in support of regulatory submissions.
• Develops clinical trial design scenarios and performs outcome analyses using computer simulation techniques, with the goal to advise on clinical trial designs with the highest probability of success.
• Responsible for identifying, interpreting, organizing, executing and coordinating projects.
• Plans and develops R&D projects with major impact on drug development.
• Serves as technical expert in the application of PK/PD modeling theories, concepts, principles and processes.
• Maintains liaisons within and outside the organization. Represents the organization on scientific matters within the worldwide scientific community.
• Acts as a trainer/coach for junior staff in the department.
• Helps to advance the science in the field, identifies research opportunities and coordinates them, both internally and externally.

Other Accountabilities & Tasks

• Trains new hires and in-house contractors on Pharmacometrics-related processes
• Engages with the scientific Pharmacometrics community and related sciences via internal/external presentations, trainings, educational events and/or meetings
• Carries out functional responsibilities in accordance with applicable SOPs/Guidelines and Regulatory requirements
• Assists in process improvement initiatives and SOP/Guideline development

Qualifications

Minimum Qualifications / Experience

• Ph D or equivalent in Pharmaceutical Sciences, Clinical Pharmacology, Chemical/Biomedical Engineering or Biological Sciences. With minimum 10 years of pharmaceutical development experience in the various aspects of modeling and simulation.
• In-depth knowledge of pre-clinical and clinical pharmacokinetics, drug metabolism, and PK/PD modeling and simulation principles. Professional experience in planning, conducting, evaluating and reporting PK/PD/Pharmacometric studies in R&D environment.
• Excellent knowledge of Statistics and Drug Development in general.
• Author or co-author of minimally 10-15 peer-reviewed publications.

Technical Knowledge and Skills

• Fluent in written and spoken English
• A fundamental understanding of clinical and pre-clinical drug development
• Expertise in advanced PK & PK/PD modeling and simulation (pharmacometric) concepts and methods
• Advanced knowledge of non-linear mixed effect modeling
• Expertise in using R and NONMEM, among other softwares
• Demonstrated internal and external leadership skills in areas related to Pharmacometrics and model-informed drug development
• Has established a level of expertise or scientific reputation though multiple publications and presentations

Non-Technical Competencies and Skills

• Good written and oral communication skills (communication)
• Ability to build and maintain effective working relationships inside and outside the department; ability and willingness to work in a cross-functional team environment (building strategic working relationships)
• Ability to multi-task and prioritize assignments, establishing courses of action for self and others to ensure that work is completed efficiently and in a timely manner (planning, organizing and time management)
• Actively identifying new areas for learning, and application to the job (continuous learning)
• Good sense of cultural sensitivity and diversity (cultural diversity)
• Self motivated with the ability to work independently with minimal supervision (personal accountability)
• Ability to interface with people of various groups (e.g., clinical, bioanalytical, data management, etc) and disciplines
• Ability to provide leadership to own team and division
• Ability to translate creative and innovative approaches into the solution of problems and the timely advancement of projects

Benefits
We offer a competitive salary and extensive benefits package. The health and well-being of our employees is a priority, we have a flexible working environment as we value work-life balance. We offer career development opportunities for those who want to grow and be part of our organisation. For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits
Johnson & Johnson Family of Companies are Affirmative Action and Equal Opportunity Employers, and all qualified applicants will be considered for employment without regard to any other characteristic protected by law.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform important job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.