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

Role Description

The role of this position is to provide clinical pharmacology input into all phases of both small and large molecule drug development across multiple therapeutic areas, such as CNS, Nephrology, Infectious Disease, Immunology, and so on. The responsibilities will include, but are not limited to:

• Supporting all clinical pharmacology activities related to pre-IND, IND, Phase 1-3, PK, PK/PD, and regulatory submissions.
• Supporting study design, execution, and reporting of clinical studies.
• Working closely with multi-functional project teams, interacting with non-clinical and bioanalytical team members for design and execution of first-in-human, mass balance, and drug interaction studies.
• Authoring the clinical pharmacology section in submission documents and representing the department at different product development team meetings.
• Participating in the planning of pharmacometrics strategies and providing input on modeling and simulation activities.
• Interacting with early development and business development team members as well as external collaborators to assess/lead development and selection of pre-IND and early phase assets.

Additional responsibilities include:

• Supporting clinical pharmacology activities related to clinical study design, protocol development, study execution, reporting, and interpretation of data.
• Serving as clinical pharmacology lead on cross-functional project teams and supporting model-based drug development strategies for ongoing projects.
• Conducting translational or clinical PK and PK/PD data plotting and analysis, such as noncompartmental analysis (NCA), correlation analysis, exposure-response analysis, and meta-analysis.
• Working closely with the pharmacometrics team and providing input related to analysis and reporting of PK, PK/PD, and exposure-response.
• Authoring clinical pharmacology sections in regulatory documents for regulatory filings including annual reports, investigator’s brochure, IND/NDA applications, and pediatrics development plans; authors scientific manuscripts or other publications.
• Working with bioanalytical team members on activities related to assay development, sample management, pharmacogenomics, and biomarker development.
• Working with formulation development groups and providing support for activities related to formulation development, dissolution testing, in vivo-in vitro correlations (IVIVC), in vivo PK study, and biowaivers for pre- and post-approval formulations.
• Managing clinical pharmacology activities related to project budgets, outsourcing of PK and PK/PD analyses, contract requisition, SOW, and approval of invoices.

Qualifications

• In-depth knowledge of clinical pharmacology, PK, PD, drug metabolism, biopharmaceutics, and bioanalytical chemistry.
• Hands-on experience in PK and PK/PD analysis using software, such as Phoenix NLME, R, 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.
• Must be able to apply scientific knowledge to drug development, anticipate and identify core problems, apply insightful analysis, and solve problems effectively.
• Strong hands-on experience related to clinical pharmacology.
• Strong organization skills.
• Strong communication (verbal and writing) skills.
• Flexibility to react rapidly to changing situations/environment.

Requirements

• PhD, PharmD, MS in Clinical Pharmacology (or a related area such as Biomedicine, Pharmacokinetics, Pharmacometrics, Clinical Pharmacology, Pharmaceutics) with a minimum of 4 years of industry experience in these areas.
• Experience in population PK and PK/PD modeling and statistical models is a plus.

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.