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Otsuka Pharmaceutical

Global pharma maker of Abilify

Associate Director - Quantitative Pharmacology, Clinical Pharmacology

Quantitative Biology & BiostatisticsConfirmed live in the last 24 hours
Full-timePrinceton, NJ, USA

About the Job

Requirements

  • In-depth knowledge of clinical pharmacology, pharmacokinetics, pharmacodynamics, drug metabolism, biopharmaceutics, bioanalytical chemistry, and Phoenix NLME.
  • Working knowledge of Phase I clinical operations, drug development, multi-region regulatory requirements, and pharmacokinetic/pharmacodynamic analysis.
  • 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 in the specified areas to company products, anticipate and identify core problems, analyze them, and solve problems effectively.
  • Strong leadership experience related to clinical pharmacology.
  • Strong organizational skills.
  • Strong communication skills.
  • Flexibility to react rapidly to changing situations and environments.
  • PhD, PharmD, or MS in Clinical Pharmacology or a related area such as pharmacokinetics, pharmacology, or pharmaceutics.
  • At least 5 years of experience in the specified areas.

Responsibilities

  • Support clinical pharmacology activities related to pre-IND, IND, Phase 1–3, pharmacokinetic and pharmacokinetic/pharmacodynamic activities, and regulatory submissions.
  • Support study design, execution, reporting, and interpretation for clinical pharmacology studies.
  • Conduct pharmacokinetic and pharmacokinetic/pharmacodynamic analyses.
  • Work closely with pharmacometrics team members and provide input related to analysis and reporting of pharmacokinetic and pharmacokinetic/pharmacodynamic results.
  • Author clinical pharmacology sections for regulatory filings, including annual reports, investigator brochures, IND/NDA applications, and pediatric development plans.
  • Work with bioanalytical team members on assay development, sample management, pharmacogenomics, and biomarker development.
  • Work with formulation development groups on formulation development, dissolution testing, in vivo–in vitro correlations, and biowaivers for pre- and post-approval formulations.
  • Manage clinical pharmacology activities related to project budgets, outsourcing of pharmacokinetic and pharmacokinetic/pharmacodynamic analyses, contract requisitions, statements of work, and invoice approvals.
  • Train and mentor staff in clinical pharmacology.
  • Serve as clinical pharmacology lead and pharmacometrics representative on multiple project teams, and support model-based drug development strategies for ongoing projects.
  • Provide input into all phases of drug development, including dose finding, dose optimization, exposure-response, and pediatric development.
  • Closely interact with non-clinical and bioanalytical team members to design and execute first-in-human, mass balance, and drug interaction studies.
  • Represent the department at product development team meetings.
  • Participate in pharmacometrics and simulation and modeling plans, and provide input on modeling and simulation activities.
  • Interact with early development and business development team members and external collaborators to assess and lead development and selection of pre-IND and early-phase assets.

Desired Qualifications

  • Experience in population pharmacokinetic and pharmacokinetic/pharmacodynamic modeling and statistical models is a plus.

About the Company

Otsuka Pharmaceutical

Global pharma maker of Abilify

Otsuka Pharmaceutical develops and markets medicines and health products worldwide, including prescription drugs and nutraceutical beverages. Its product lineup ranges from pharmaceutical treatments such as Abilify (an antipsychotic) to consumer health drinks like Pocari Sweat, which helps replenish electrolytes. Abilify works as a psychiatric medication used to treat conditions such as schizophrenia and bipolar disorder, while Pocari Sweat is an ion-replacement beverage designed to restore minerals and fluids after activity or heat. The company differentiates itself through a long history dating back to its founding in 1921, a broad, globally scaled portfolio spanning drugs and health beverages, and a focus on health improvements across populations. Its stated goal is to create new products for better health worldwide.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Tokyo, Japan
Founded
1921

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