Director of Quantitative Pharmacology and Pharmacometrics
4 weeks ago
Otsuka Pharmaceutical Company is a global healthcare leader with a commitment to improving human health worldwide. As a Director of Quantitative Pharmacology and Pharmacometrics, you will play a critical role in advancing drug development by serving as the key expert on all pharmacometrics matters relating to assigned clinical projects.
Key Responsibilities:
- Oversee all pharmacometrics activities related to pre-IND, IND, phase 1-3, PK, PK/PD, and regulatory submissions.
- Lead analysis, execution, and reporting of pharmacometrics studies.
- Provide input into all phases of drug development, including dose finding, dose optimization, exposure-response, and pediatric development.
- Interact with non-clinical and bioanalytical team members for design and execution of first-in-human, mass balance, and drug interaction studies.
Requirements:
- PhD in pharmacometrics or a related area with a minimum of 8-10 years of industry experience.
- Strong technical and hands-on experience in population PK and PK/PD modeling.
- In-depth knowledge of pharmacometrics, population PK and PK/PD modeling, clinical pharmacology, drug metabolism, biopharmaceutics, and bioanalytical chemistry.
- Excellent working knowledge of phase 1 clinical operations, drug development, multi-region regulatory requirements.
What We Offer:
- Comprehensive medical, dental, vision, and prescription drug coverage.
- Company-provided Basic Life, AD&D, Short-term and Long-term Disability insurance.
- Tuition reimbursement and a 401(k) match.
- PTO allotment each calendar year, paid holidays, and paid leave programs.
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