EMD Serono, Inc. ยท 3 days ago
Scientific Director, Pharmacometrics
Billerica, MA
Full-time
Hybrid
Lead/Staff, Director/Executive
$186K/yr - $278K/yr
5+ years expEMD Serono, Inc. is a global leader in Healthcare, Life Science, and Electronics, dedicated to improving and prolonging lives through innovative solutions. The Scientific Director, Pharmacometrics role involves developing and executing Model Informed Drug Development strategies in collaboration with cross-functional teams, focusing on enhancing pharmacometrics capabilities and ensuring high-quality deliverables.
BiotechnologyHealth CareHealth Diagnostics
Responsibilities
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
Qualification
Required
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
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
Benefits
Health insurance
Paid time off (PTO)
Retirement contributions
Other prequisites
Company
EMD Serono, Inc.
We aspire to create, improve and prolong life for people living with difficult-to-treat conditions like infertility, multiple sclerosis and cancer.
1001-5000 employees
H1B Sponsorship
EMD Serono, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (12)
2023 (7)
2022 (10)
2021 (12)
2020 (9)
Funding
Current Stage
Late StageLeadership Team
Miguel Alcalde
President of EMD Serono
Recent News
2025-12-21
Business Standard India
2025-12-20
2025-12-20
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