Job Id
290062
Billerica, Massachusetts, United States
Job Type
Full-time
Work Your Magic with us! Start your next chapter and join EMD Serono.
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.

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/PD M&S frameworks that preserve adequate mechanistic resolution for applications in clinical development
• Stay up-to-date with scientific advancements in pharmacometrics and share expertise with colleagues

MINIMUM QUALIFICATIONS:

• PhD in pharmacometrics or a related disciple (e.g. clinical pharmacology, statistics, engineering, mathematics)
• 5+ years of pharmaceutical industry experience with hands-on pharmacometrics modeling and application of MIDD principles in a drug-development setting
• Position requires both domestic and international travel up to 15% of time

PREFERRED QUALIFICATIONS:

• Excellent knowledge of and experience in application of population PK/PD models, exposure-response models, disease progression models, clinical trial simulations, Bayesian methodologies, and model-based meta-analyses to drive MIDD
• 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
• Knowledge of emerging areas of pharmacometrics including applications of machine learning/ artificial intelligence for model-informed precision medicine development
• 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 celebrate all dimensions of diversity and believe that it 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!
  and become a part of our diverse team!
  If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html

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.