Senior Director, Quantitative Pharmacology

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $230.7k - $345k / year

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 0%

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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 clinical pharmacology activities and deliverables across all stages of clinical development • Support the Head of Quantitative Pharmacology in managing and growing the functional team • Mentor and train junior scientists and develop clinical pharmacology talent • Oversee pre-IND, IND, Phase 1–3, PK, PK/PD, and regulatory submission deliverables • Review and approve Clinical Pharmacology reports and analyses • Oversee clinical pharmacology strategy, including dose finding, dose optimization, exposure-response, and pediatric development • Serve as Clinical Pharmacology Lead on early- and late-stage development teams • Provide data-driven plans and communicate results and strategy to development teams • Coordinate clinical pharmacology interactions with toxicology, DMPK, bioanalytical, biomarker, pharmacometrics, statistics, clinical, regulatory, ADME, and CMC functions • Review business development opportunities and make go/no-go recommendations for QTR • Help set department strategy, growth, and cross-functional alignment • Lead clinical pharmacology strategy and integrate it into clinical development plans for small- and large-molecule drugs • Lead development and approval of clinical pharmacology sections for regulatory filings • Support MIDD strategies and PK/PK/PD modeling analyses for dose selection and efficacy and safety assessments • Support biomarker development and incorporation into early-phase studies • Use innovative data analysis methods to optimize doses, dosage regimens, and study designs • Review and approve healthy-subject clinical study designs and protocols • Work with formulation, biomarker, and bioanalytical teams on formulation development, assay development, sample management, PGx, and biomarker strategy

🎯 Requirements

• PhD in Clinical Pharmacology or a related area such as pharmacokinetics, pharmacology, or pharmaceutics • Minimum of 12 years of experience in these areas • Extensive experience developing and executing clinical pharmacology strategies for early- through late-stage programs, including registrational support • In-depth knowledge of early-phase study design, PK, PD, drug metabolism, biopharmaceutics, biomarkers, and bioanalytical assays for small molecules and monoclonal antibodies • Hands-on experience in PK and PK/PD data analysis and Phoenix NLME • Excellent working knowledge of Phase I clinical operations, drug development principles, multi-region regulatory requirements, and PK/PD analysis • Strong working knowledge of formulation development and clinical development • Current awareness of developments in clinical pharmacology, pharmacometrics, and guidance documents • Ability to apply scientific knowledge to identify core problems, perform insightful analysis, 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 • Willingness to travel 20% • Experience in early-phase clinical protocol development is a plus

🏖️ Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage • Company-provided basic life insurance • Accidental death and 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 • Incentive opportunity