Senior Scientist, non-clinical & clinical PK/PD Modeling and Simulation

Mission

Define and drive non-clinical and clinical PK/PD strategies for NCE, NBE or other drug modalities, through modeling & simulation tools to support hypothesis generation, candidate selection, human dose predictions, design of clinical trials or regulatory interactions. Provide guidance with respect to common model informed drug development (MIDD) needs, such as population PK (PopPK), Exposure-Response (ER), PBPK or Quantitative Systems Pharmacology.

Tasks and Responsibilities

• 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 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)

Competencies

• 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.
• Excellent inter-cultural understanding.

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.