Scientific Director, Pharmacometrics

Vor 3 Tagen


Darmstadt, Deutschland Merck Group Vollzeit

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you’ve got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

**Your Role**

The role of Scientific Director, Pharmacometrics, in Quantitative Pharmacology within the broader Clinical Measurement Sciences organization, will be a scientific and cross-functional role, responsible for developing and executing Model Informed Drug Development (MIDD) plans and strategies from early translational to late-stage clinical development in cross-functional drug discovery and development project teams in close collaboration with colleagues in Clinical Pharmacology, Translational Quantitative Pharmacology, Biostatistics, Data Sciences, Patient-Focused Real-World Evidence, Clinical Biomarkers and Diagnostics, Research, Clinical Development and other colleagues within the R&D organization.

In this role, you will participate in activities to strengthen pharmacometrics platform capabilities by contributing to the strategic use of modeling & simulation (M&S) methodologies across disease areas, in alignment with the clinical development plan. There will be close engagement with all key stakeholders to ensure timely and high-quality pharmacometrics deliverables for the program.

You will be responsible for pharmacometrics activities executed internally or in collaboration with external CROs and will provide close scientific and technical supervision. You will also be expected to independently manage multiple projects simultaneously and participate in discussions and presentations.

**Who You Are**
- PhD in pharmacometrics or a related disciple (e.g. clinical pharmacology, statistics, engineering, mathematics)
- Position requires both domestic and international travel up to 20% of time
- Thorough understanding of global regulatory guidelines relevant to MIDD (e.g., Population PK, exposure-response, pediatric extrapolation)
- Ability to translate highly mechanistic systems models to population PK/PD frameworks in clinical development
- Experience in pharmacostatistical modeling methods and sound understanding of the principles of statistics including Bayesian methodologies as applicable for advanced pharmacometrics modeling and clinical trial simulations
- Experience with model-informed development of both small molecules and biologics and across all phases of clinical development is required
- Good command of NONMEM and R is an absolute prerequisite. Experience with other tools (e.g., MONOLIX, PsN, Xpose, SAS, Stan, Python, MATLAB and Simcyp) is desired
- General knowledge of oncology, neurology and/or immunology, is desirable

**What we offer**: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress



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