Associate Director, Quantitative Pharmacology, Clinical Pharmacology

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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

• Provide clinical pharmacology input across all phases of small- and large-molecule drug development across multiple therapeutic areas • Support clinical pharmacology activities related to pre-IND, IND, Phase 1–3, PK, PK/PD, and regulatory submissions • Support clinical study design, protocol development, study execution, reporting, and data interpretation • Serve as clinical pharmacology lead on cross-functional project teams • Support model-based drug development strategies • Conduct translational or clinical PK and PK/PD data plotting and analyses, including NCA, correlation, exposure-response, and meta-analysis • Work with pharmacometrics teams on PK, PK/PD, and exposure-response analysis and reporting • Author clinical pharmacology sections for regulatory filings, including annual reports, investigator brochures, IND/NDA applications, and pediatric development plans • Author scientific manuscripts and other publications • Collaborate with non-clinical, bioanalytical, formulation development, early development, business development, and external collaborator teams • Support assay development, sample management, pharmacogenomics, and biomarker development • Support formulation development, dissolution testing, IVIVC, in vivo PK studies, and biowaivers • Manage project budgets, outsourced PK and PK/PD analyses, contract requisitions, statements of work, and invoice approvals • Participate in pharmacometrics strategy planning and modeling and simulation activities • Assess and lead development and selection of pre-IND and early-phase assets

🎯 Requirements

• In-depth knowledge of clinical pharmacology, PK, PD, drug metabolism, biopharmaceutics, and bioanalytical chemistry • Hands-on experience in PK and PK/PD analysis using software such as Phoenix NLME and R • Excellent working knowledge of Phase I clinical operations, drug development, multi-region regulatory requirements, and PK/PD analysis • Strong working knowledge of formulation development, drug development, and clinical development • Current awareness of developments in clinical pharmacology, pharmacometrics, and guidance documents • Ability to apply scientific knowledge to drug development, identify core problems, perform insightful analysis, and solve problems effectively • Strong hands-on clinical pharmacology experience • Strong organizational skills • Strong verbal and written communication skills • Flexibility to react rapidly to changing situations and environments • PhD, PharmD, or MS in Clinical Pharmacology or a related area such as Biomedicine, Pharmacokinetics, Pharmacometrics, Clinical Pharmacology, or Pharmaceutics • Minimum 4 years of industry experience in the specified areas • Experience in population PK and PK/PD modeling and statistical models is a plus • Ability to travel 15%

🏖️ Benefits

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