Director, Quantitative Pharmacology – Clinical Pharmacology

🕒 June 29

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Otsuka Pharmaceutical Companies (U.S.)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

Pharmaceuticals • Healthcare • Biotechnology

Otsuka Pharmaceutical Companies (U. S. ) is a prominent player in the pharmaceutical manufacturing industry, dedicated to creating innovative products for better health worldwide. The company comprises two main entities: Otsuka America Pharmaceutical, Inc. (OAPI), which is focused on commercializing Otsuka-discovered and in-licensed products in North America, and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), which specializes in the clinical development and global registration of innovative healthcare solutions, particularly in the field of neuroscience.

📋 Description

• Oversee all clinical pharmacology activities related to pre-IND, IND, phase1-3, PK, PK/PD and regulatory submissions • Lead study design, execution and reporting of clinical pharmacology studies • Provide input into all phases of drug development including dose finding, dose optimization, exposure-response and pediatric development • Interact closely with non-clinical and bioanalytical team members for design and execution of first-in-human, mass balance and drug interaction studies • Author/reviewer of clinical pharmacology submission documents and represent the department at product development team meetings • Participate in pharmacometrics and simulation and modeling plans • Assess/lead development and selection of pre-IND and early phase assets

🎯 Requirements

• PhD in Clinical Pharmacology (or a related area such as pharmacokinetics, pharmacology, pharmaceutics) • Minimum of 10 years of experience in these areas • In-depth knowledge of clinical pharmacology, PK, PD, drug metabolism, biopharmaceutics, and bioanalytical chemistry • Hands-on PK and PK/PD analysis • Excellent working knowledge of phase I clinical operations, drug development, multi-region regulatory requirements and PK/PD analysis • Current awareness of the latest developments in clinical pharmacology, pharmacometrics and guidance documents • Strong leadership experience related to clinical pharmacology. • Strong organization skills. • Strong communication skills. • Flexibility to react rapidly to changing situations/environment.

🏖️ Benefits

• Comprehensive medical, dental, vision, prescription drug coverage • Company provided basic life, accidental death & dismemberment • Short-term and long-term disability insurance • Tuition reimbursement • Student loan assistance • A generous 401(k) match • Flexible time off • Paid holidays • Paid leave programs • Other company provided benefits