обновлено 3 дня назад
Principal Investigator, Clinical Pharmacology & Pharmacometrics
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Principal Investigator, Clinical Pharmacology & Pharmacometrics (Pharmacometrics): Developing and executing pharmacometric modeling and simulation strategies for clinical development programs involving biologics and small molecules with an accent on population PK/PD, semi-mechanistic PK/PD, PBPK, and QSP. Focus on interpreting clinical data, supporting regulatory decisions, collaborating across development functions, and presenting findings in scientific forums.
Location: Wilmington, Delaware, United States
Company
is a global biopharmaceutical company developing proprietary therapeutics in Hematology, Oncology, Inflammation and Autoimmunity, with operations in North America, Europe, and Asia.
What you will do
- Develop and execute pharmacometric modeling and simulation strategies for clinical development programs and regulatory submissions.
- Perform PK/PD and population PK/PD analyses and interpret results for clinical teams and management.
- Conduct semi-mechanistic PK/PD, PBPK, and QSP modeling and simulations for critical development decisions.
- Collaborate with clinical development, biostatistics, data management, medical writing, and regulatory affairs.
- Present findings internally and at external scientific meetings and publish manuscripts in peer-reviewed journals.
Requirements
- Ph.D. in Pharmacokinetics, Pharmacometrics, Pharmacology, Pharmaceutical Science, Chemical or Biomedical Engineering, Statistics, or a related field.
- 1–5 years of post-Ph.D. experience or 3–7 years of post-M.Sc. experience in population PK/PD, PBPK, and/or QSP modeling and simulations.
- Experience with multiple software packages such as R, NONMEM, Monolix, MATLAB, Simcyp, GastroPlus, or related pharmacokinetic and data visualization software.
- Scientific understanding of biopharmaceutical and ADME properties of small molecules and biologics.
- Experience scheduling and executing multiple programs and projects in a dynamic research environment.
- Excellent communication and presentation skills, with the ability to work independently.
Culture & Benefits
- Work in a science-driven biopharmaceutical research environment.
- Collaborate with multidisciplinary clinical development and regulatory functions.
- Contribute to research supporting therapeutics for patients with unmet medical needs.
- is committed to creating a diverse and equal-opportunity work environment.
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