Associate Director, Quantitative Pharmacology, Pharmacometrics

Job Summary Supports all pharmacometrics activities related to pre-IND, IND, phase1-3, PK, PK/PD and regulatory submissions. Conducts analysis, execution and reporting of pharmacometrics studies. Provides input into all phases of drug development including, but not limited to dose finding, dose optimization, exposure-response and pediatric development. Author of clinical pharmacology and pharmacometrics submission documents and representative of the department at different product development team meetings. Conducts pharmacometrics and simulation and modeling activities to provide input on modeling and simulation activities. Interacts 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. Job Description Conducts pharmacometrics activities related to study design, protocol development, study execution, reporting and interpretation of data. Conducts population PK, PK/PD and modeling and simulation. Provides pharmacometrics analysis and participates in activities related to analysis and reporting of population PK and PK/PD analyses. Authors pharmacometrics sections of clinical pharmacology documents 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 sample management, pharmacogenomics and biomarker development and provide analysis support related to PK and PK/PD. Work with formulation development groups and provide support for PK and PK/PD activities related to formulation development, in vivo-in vitro correlations and biowaivers for pre- and post-approval formulations. Manage pharmacometrics activities related to project budgets, outsourcing of PK and PK/PD analyses, contract requisition, SOW and approval of invoices. Interact with clinical pharmacology to support population PK and PK/PD modeling Serve as pharmacometrics lead on multiple project teams and as a team member on other key projects as needed and supports model-based drug development strategies for ongoing projects. Qualifications/ Required Knowledge/ Experience and Skills: Knowledge, Skills, and Competencies • In-depth knowledge of pharmacometrics, population PK and PK/PD modeling, clinical pharmacology, drug metabolism, biopharmaceutics, and bioanalytical chemistry. • Hands PK and PK/PD analysis and statistical analysis using NonMEM, Phoenix NLME, Julia, R etc. Excellent working knowledge of phase I clinical operations, drug development, multi-region regulatory requirements. • Good working knowledge of formulation development, drug development and clinical development. • Current awareness of the latest developments in clinical pharmacology and guidance documents. Skills •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 technical and hands on experience related to pharmacometrics, population PK and PK/PD modeling •Strong organization skills. •Strong communication skills. •Flexibility to react rapidly to changing situations/environment Travel 20% Educational Qualifications PhD in pharmacometrics (or a related area such as pharmacokinetics, clinical pharmacology, pharmacology, or a related area) with a minimum of 5 years of experience in these areas. Strong technical and hands on experience in population PK and PK/PD modeling. Competencies Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business. Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders. Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals. Empowered Development - Play an active role in professional development as a business imperative. Minimum $169,222.00 - Maximum $253,000.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. Application Deadline: This will be posted for a minimum of 5 business days. Company 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, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. 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Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” In the U.S., Otsuka is comprised of two companies, Otsuka America Pharmaceutical, Inc., and Otsuka Pharmaceutical Development & Commercialization, Inc., that share a deep commitment to the development and commercialization of innovative products in the spaces of neuroscience, nephrology, and digital medicine. Driven by our purpose to defy limitation, so that others can too, we have an unwavering belief in doing more and transcending expectations. In going above and beyond—under any circumstances—for patients, families, providers, and for each other. It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day. OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023. We invite you to explore our open positions for an opportunity to join our 2,200 colleagues in the U.S. whose passion for our mission and pride in our company have earned us certification as a Great Place to Work by the Great Place to Work Institute.