[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.

Responsibilities

• Lead clinical pharmacology activities related to study design, protocol development, study execution, reporting and interpretation of data
• Conduct PK and PK/PD analysis
• Work closely with pharmacometrics team members and provides input related to analysis and reporting of PK and PK/PD
• Lead development of clinical pharmacology sections for regulatory filings including annual reports, investigator’s brochure, IND/NDA applications and pediatrics development plans
• Work with bioanalytical team members on activities related to assay development, sample management, pharmacogenomics and biomarker development
• Work 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 formulations
• Manage clinical pharmacology activities related to project budgets, outsourcing of PK and PK/PD analyses, contract requisition, SOW and approval of invoices
• Training and mentoring of staff related to clinical pharmacology
• Serve as clinical pharmacology lead and pharmacometrics representative on multiple project teams and support model-based drug development strategies for ongoing projects

Skills

• In-depth knowledge of clinical pharmacology, PK, PD, drug metabolism, biopharmaceutics, and bioanalytical chemistry
• Hands-on PK and PK/PD analysis and Phoenix NLME, etc
• Excellent working knowledge of phase I clinical operations, drug development, multi-region regulatory requirements and PK/PD analysis
• Great working knowledge of formulation development, drug development and clinical development
• Current awareness of the latest developments in clinical pharmacology, pharmacometrics and guidance documents
• PhD in Clinical Pharmacology (or a related area such as pharmacokinetics, pharmacology, pharmaceutics) with a minimum of 10 years of experience in these areas
• Experience in population PK and PK/PD modeling and statistical models a plus
• Must 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 effectively
• Strong leadership experience related to clinical pharmacology
• Strong organization skills
• Strong communication skills
• Flexibility to react rapidly to changing situations/environment

Benefits

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

Company Overview

Company H1B Sponsorship