Scientific Director, Pharmacometrics
Company: emd serono
Location: Billerica
Posted on: March 21, 2026
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Job Description:
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. Thats
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, is a scientific and
cross-functional role, responsible for developing and executing
Model Informed Drug Development (MIDD) plans and strategies from
the early translational to the 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, the
incumbent 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. The incumbent will be responsible for pharmacometrics
activities executed internally or in collaboration with external
CROs and will provide close scientific and technical supervision.
The incumbent will also be expected to independently manage
multiple projects simultaneously and participate in discussions and
presentations. This position reports to the Global Head of
Pharmacometrics and Systems Pharmacology. Key Accountabilities: •
Prepare, execute, present, report and/or supervise modeling &
simulation projects; 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 • 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. • Keep up to date with scientific advancements in
pharmacometrics and share expertise with colleagues. Who You Are:
Minimum Qualifications: • PhD in Pharmacometrics or a related
disciple (e.g. Clinical Pharmacology, Statistics, Engineering,
Mathematics) • 5 years of 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 20% 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
Keywords: emd serono, Springfield , Scientific Director, Pharmacometrics, Science, Research & Development , Billerica, Massachusetts
