[Remote] Director, Quantitative Pharmacology, Clinical Pharmacology

Note: The job is a remote job and is open to candidates in USA. Otsuka Pharmaceutical Companies (U.S.) is focused on advancing innovative pharmaceuticals, and they are seeking a Director of Quantitative Pharmacology in Clinical Pharmacology. This role oversees clinical pharmacology activities, leads study design and execution, and provides input into all phases of drug development, including regulatory submissions and collaboration with various teams.ResponsibilitiesLead clinical pharmacology activities related to study design, protocol development, study execution, reporting and interpretation of dataConduct PK and PK/PD analysisWork closely with pharmacometrics team members and provides input related to analysis and reporting of PK and PK/PDLead development of clinical pharmacology sections for regulatory filings including annual reports, investigator’s brochure, IND/NDA applications and pediatrics development plansWork with bioanalytical team members on activities related to assay development, sample management, pharmacogenomics and biomarker developmentWork with formulation development groups and provide support for activities related to formulation development, dissolution testing, in vivo-in vitro correlations and biowaivers for pre- and post-approval formulationsManage clinical pharmacology activities related to project budgets, outsourcing of PK and PK/PD analyses, contract requisition, SOW and approval of invoicesTraining and mentoring of staff related to clinical pharmacologyServe as clinical pharmacology lead and pharmacometrics representative on multiple project teams and support model-based drug development strategies for ongoing projectsSkillsIn-depth knowledge of clinical pharmacology, PK, PD, drug metabolism, biopharmaceutics, and bioanalytical chemistryHands-on PK and PK/PD analysis and Phoenix NLME, etcExcellent working knowledge of phase I clinical operations, drug development, multi-region regulatory requirements and PK/PD analysisGreat working knowledge of formulation development, drug development and clinical developmentCurrent awareness of the latest developments in clinical pharmacology, pharmacometrics and guidance documentsPhD in Clinical Pharmacology (or a related area such as pharmacokinetics, pharmacology, pharmaceutics) with a minimum of 10 years of experience in these areasExperience in population PK and PK/PD modeling and statistical models a plusMust be able to apply scientific knowledge (in the areas specified above) to further the company's products, anticipate and identify core problems, apply insightful analysis, and solve problems effectivelyStrong leadership experience related to clinical pharmacologyStrong organization skillsStrong communication skillsFlexibility to react rapidly to changing situations/environmentBenefitsComprehensive medical, dental, vision, prescription drug coverageCompany provided basic life, accidental death & dismemberment, short-term and long-term disability insuranceTuition reimbursementStudent loan assistanceA generous 401(k) matchFlexible time offPaid holidaysPaid leave programsOther company provided benefitsCompany OverviewThere are two Otsuka pharmaceutical industry companies in the U.S.: Otsuka America Pharmaceutical, Inc. It was founded in 1989, and is headquartered in Rockville, Maryland, USA, with a workforce of 1001-5000 employees. Its website is https://www.otsuka-us.com.Company H1B SponsorshipOtsuka Pharmaceutical Companies (U.S.) has a track record of offering H1B sponsorships, with 2 in 2026, 8 in 2025, 6 in 2024, 11 in 2023, 5 in 2022, 9 in 2021, 13 in 2020. Please note that this does not guarantee sponsorship for this specific role.