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Senior Scientist, non-clinical & clinical PK/PD Modeling and Simulation
Mission
* Lead the implementation of currently unavailable M&S tools & capabilities within the company.
* Engage proactively in discovery and development projects with M&S needs for NCEs, NBEs or other drug modalities in a multidisciplinary environment.
* Devise the PK/PD strategy and use of M&S to support the design of in-vitro/in-vivo mechanistic studies.
* Deliver PK, PK/PD or PBPK modelling to support the optimization of drug candidates in preclinical projects of different modalities.
* Strong interaction with translational medicine and clinical teams to guide dose selection.
* Human PK predictions to estimate efficacious exposure/dose and support the clinical development program (e.g. PopPK & ER).
* Balance the needs of M&S in R&D projects according to available internal capabilities or through outsourcing to pharmacometric CROs.
* Provide M&S support/review for IND / NDA / BLA submissions.
* Foster a continuous update of scientific M&S knowledge to keep up high standards within the Company.
Education
* Bachelor of Science, Master of Science or PhD (PhD degree in a field related to pharmacometrics is preferable) in either Pharmacokinetics, Pharmacology, Pharmaceutical/Biotechnological Sciences, Biomedical/Chemical Engineering, Applied Mathematics, or a health-related discipline.
Specific Knowledge
* Good understanding of translational medicine aspects to connect preclinical and Clinical DMPK.
* Comprehensive understanding of the concepts of pharmacokinetics and pharmacodynamics during drug discovery & development.
* Good understanding of the Principles for Model-Informed Drug Development.
* Proven skills in PK, PK/PD, PBPK and/or longitudinal disease modelling.
* Proficiency and extensive hands-on experience with modeling software such as MATLAB, R, Phoenix, or NONMEM, among others.
Experience
* At least 5 years of experience in the field (preferentially in an industrial environment).
* Teamwork and personal leadership.
* Ability to work in a matrix environment, multi-task, meet deadlines and deal with evolving priorities.
* Strategic thinker with leadership skills and the ability to work collaboratively across various teams and disciplines.
* Capable of building and maintaining professional networks to support collaborative efforts.
* Fluent in both oral and written English, essential for effective communication and documentation.
Values
* Care: we listen & empathize, we value diverse perspectives & backgrounds and we help each other succeed.
* Courage: we challenge the status quo, we take full ownership and we learn from our success & failures.
* Innovation: we put the patient and customer at the center, we create novel solutions and we empower entrepreneurial mindsets.
* Simplicity: we act decisively and avoid over-analysis, we understand why before we act and we are agile & keep things simple.
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