[Hiring] Senior Director, Quantitative Pharmacology @Otsuka Pharmaceutical Co., Ltd.

Role Description

As a leadership role in the Quantitative Pharmacology team at the Quantitative Translational Research (QTR) department, this role will oversee clinical Pharmacology activities, assist in department technical growth, and contribute to key metrics of success of the Clinical Pharmacology team across all stages of clinical development. The role will also support the head of Quantitative Pharmacology in managing/growing the function team, mentoring/training junior scientists, and overseeing project-level clinical pharmacology activities, leading development of SOP/WP or cross-functional working processes.

• Oversee clinical pharmacology deliverables related to pre-IND, IND, phase 1-3, Pharmacokinetics (PK), Pharmacokinetics-Pharmacodynamics (PK/PD) reports, and regulatory submissions.
• Review and approve Clinical Pharmacology reports and analyses.
• Oversee clinical pharmacology strategy and provide input into clinical development strategy and activities related to all phases of drug development.
• Serve as a Clinical Pharmacology Lead in Early- and Late-stage development teams.
• Provide concise, data-driven actionable plans and efficiently communicate results and Clinical Pharmacology strategy to development teams.
• Oversee interactions of clinical pharmacology team with other QTR functions.
• Review business development opportunities and make go/no-go recommendations on behalf of QTR.
• Work with QTR leadership team to set department strategy, growth, and cross-functional alignment.

Qualifications

• 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, biomarker, and bioanalytical assay in small molecule and monoclonal antibody (mAb) assets.
• Hands-on experience in PK and PK/PD data analysis and Phoenix NLME.
• Excellent working knowledge of phase I clinical operations, principles of drug development, multi-region regulatory requirements, and PK/PD analysis.
• Great working knowledge of formulation development and clinical development.
• Current awareness of the latest developments in clinical pharmacology, pharmacometrics, and guidance documents.

Requirements

• PhD in Clinical Pharmacology (or a related area such as pharmacokinetics, pharmacology, pharmaceutics) with a minimum of 12 years of experience in these areas.
• Experience in early-phase clinical protocol development is a plus.
• Must be able to apply scientific knowledge to further the company’s products, anticipate and identify core problems, apply insightful analysis, and solve problems effectively.
• Strong leadership experience related to clinical pharmacology.
• Strong organization skills.
• Strong communication skills.
• Flexibility to react rapidly to changing situations/environment.
• Travel 20%.

Benefits

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