Scientific Director - Pharmacometrics

Scientific Director - Pharmacometrics
Location: Belgium or Switzerland

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 J&J site in Beerse, Belgium or Switzerland 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 processe...