Scientific Director, Pharmacometrics 1

 

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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 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.

 

KEY ACCOUNTABILITIES

 

• Prepare, execute, present, report and/or supervise modeling & simulation projects, and being responsible for summarizing and reporting pharmacometrics content in relevant regulatory submission documents (e.g., HA Briefing Documents, CTD 2.7.2)
• Develop and execute MIDD strategies/plans which are fully integrated with the overall clinical development plan
• Apply MIDD methodologies to contribute to decision making at critical milestones based on quantitative principles in close collaboration with partner functions (e.g. clinical pharmacology, biostatistics, data sciences, clinical development, research)
• Practice and promote quantitative decision-making by leveraging the totality of evidence approach and enable the integration of all relevant data within and outside the development program (including literature and competitor data, and Real World data) using state-of-the-art disease models, clinical trial simulations and Bayesian probabilistic frameworks to enhance clinical trial design and inform assessment of probability of success
• Collaborate with Translational QP to appropriately transition Quantitative Systems Pharmacology models developed in Research and preclinical development to population PK/P