J&J Family of Companies Scientific Director - Group Lead - PK/PD Modeling and Simulation in Germany
Janssen Research & Development, a member of the Pharmaceutical Companies of Johnson & Johnson, is recruiting for a Scientific Director, PK/PD Modeling and Simulation Group Head, located in Beerse, Belgium.
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
The candidate is expected to play a leading role in driving preclinical Pharmacokinetic/ Pharmacodynamic (PK/PD) strategies and human dose prediction from early discovery to First in Human (FIH). The group leader will be expected to help identify key issues in early discovery and additionally pursue new opportunities with outside partners and thought leaders to develop next generation DMPK strategies and technologies (Advanced PK/PD Modeling and Simulation techniques).
The candidate will be expected to interface with the therapeutic areas, acting as a point of contact between DMPK and other discovery (chemistry, biology, safety) and development colleagues to help guide the appropriate in vitro and in vivo ADME studies as well as the design of in vivo PK/PD studies needed using advanced modeling and simulation approaches with the goal of providing guidance for the human efficacious and starting dose for lead candidates in early discovery and development. Such approaches include (but will not be limited to) physiologically based pharmacokinetic (PBPK) approaches (Simcyp, Gastroplus and similar software), systems PK (Matlab, JDesigner, Simbiology and similar software) , and classical PK/PD approaches (Nonmem, Monolix, Winnonlin and similar software) to help (a) predict human PK profile (b) quantify the exposure / response relationship needed to quantify “efficacy” and to guide dose selection (c) help guide in vivo experimental design of both PK exposure studies as well as pharmacodynamic end points (d) help quantify and derisk any exposure related AE issues (e) help determine quantifiable in vitro in vivo extrapolation relationships across lead series.
The role includes the following responsibilities:
Develops annual research program proposals and related budgets, long-range research proposals, and technical progress reports.
Collaborates with business development, technology assessment, and others to define a diagnostic product pipeline that provides medical value.
Oversees one or more product pipelines, and the filling and balancing of those pipelines.
Creates a motivated and focused team aligned with the organizational goals of the department and with company policy.
Works together with the research and development solutions team and the operational division collaborating in new product and technology development activities and identifying development projects relevant to the company's long-term objectives and.
Hires research staff, implements training and development initiatives to optimize staff skills, conducts performance appraisals, and develops individual objectives for direct report staff. Ensures development of future leaders.
Leads and governs one or more research and development departments by taking ownership of the creation and execution of business processes. Provides technical expertise, in terms of problem solving for complex technical problems using advanced knowledge and experience.
The successful candidate will have a PhD in Pharmacology, Engineering, Mathematics, Physics, and related fields with a specific focus on pharmacological modeling with at least 12+ years of relevant industry experience. A strong understanding of DMPK principles and experience in supporting drug discovery are required. Proven skills in modeling and simulation, supported by a publication track record is highly desired. The candidate must possess excellent interpersonal, organizational, oral/written communication and teamwork skills.
Europe/Middle East/Africa-Switzerland, Europe/Middle East/Africa-United Kingdom-England, Europe/Middle East/Africa-Germany
Janssen Pharmaceutica N.V. (7555)