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Associate Director, Quantitative Clinical Pharmacology Lead
1 month ago
Takeda Pharmaceutical is seeking a highly skilled Associate Director, Quantitative Clinical Pharmacology to join our Data Sciences Institute in Cambridge, MA. As a key member of our team, you will play a critical role in harnessing the power of data and digital tools to speed the development of innovative treatments for patients worldwide.
Key Responsibilities:- Provide scientific and strategic leadership as the Global or Regional Clinical Pharmacology Lead for multiple projects on Global Program Teams and associated scientific and operational sub-teams.
- Integrate pharmacokinetic, pharmacodynamic, efficacy, and safety data from multiple sources to optimize dosing for different populations across the development continuum.
- Develop and execute clinical pharmacology plans, including integration of Model-Informed Drug Development (MIDD) principles, in close collaboration with key partner functions (e.g., pharmacometrics, statistics, and DMPK).
- Represent Clinical Pharmacology in meetings with global or regional regulatory agencies and be responsible for clinical pharmacology summary documents for regulatory submissions.
- Oversee and/or independently perform PK, PD, and pharmacometric analyses, including the interpretation of PK/PD data in close partnership with DSI and external partners.
- PharmD or PhD with 5+ years of working experience in a quantitative field with some exposure to clinical pharmacology/PK-PD.
- MS with 8+ years' working experience in a quantitative field with some exposure to clinical pharmacology/PK-PD.
- Advanced knowledge and experience in clinical pharmacology responsibilities in early & late stage and post-marketing studies.
- Formulates and executes clinical pharmacology plans including integration of MIDD principles.
- Advanced knowledge of pharmaceutical industry, overall drug development process with expertise in the cross-functional interfaces with key partners such as Pharmacometrics, Statistics, Drug Safety, Clinical Sciences, Outcomes, Digital Health, Pharmaceutical Sciences/Device, and Global Regulatory Affairs.
- Advanced knowledge of regulatory guidance for industry applicable to the design, analysis of clinical trials and process for regulatory submissions across difference regions (ICH, FDA, EMA and others).
- Advanced knowledge and/or hands-on applications in integration of PK, PD, efficacy, and safety data from multiple sources for dose selection and decision-making.
- A competitive salary range of $149,234.30.
- A comprehensive benefits package, including medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits.
- A dynamic and inclusive work environment that fosters collaboration, innovation, and excellence.
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