Senior Manager, Pharmacometrics

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary: The Senior Manager, Pharmacometrics plays a key role in advancing Kyowa Kirin’s pipeline through the application of model-informed drug development (MIDD). This position involves hands-on execution of pharmacometric analyses, including dataset programming, modeling, and simulations to inform decision-making across drug development programs. The role integrates a deep understanding of biology, clinical pharmacology, and quantitative methodologies to support program strategy and execution. Effective communication across cross-functional teams is essential to align modeling insights with clinical and regulatory objectives and to drive program success. Essential Functions: Provide strategic input on the development of Kyowa Kirin’s global assets. Build on current standards for MIDD analyses for continued improvement of workflows and processes. Effectively communicate scientific results to a wide range of audiences, internally and externally Provide input and prepare pharmacometric components of regulatory submissions. Generate MIDD plans and conduct population pharmacokinetic and exposure-response analyses. Collaborate with global clinical pharmacology colleagues and cross-functionally with the global development organization. Requirements: Ph.D. or PharmD degree in Pharmacometrics, Bioengineering, Systems Pharmacology, Mathematics, Applied Statistics, Computer Science Minimum five (5) years of experience in developing and applying pharmacometric workflows, including at least two (2) years within the pharmaceutical industry. More than two (2) years of hands-on experience with programming in R or Julia for pharmacometric analyses. Proven experience conducting nonlinear mixed-effects (NLME) analyses of pharmacokinetics (PK) and pharmacodynamics (PD). Demonstrated ability to project activity timelines and consistently deliver high-quality results within established deadlines. Technical Skills Ability to conduct hands-on modeling and simulation using appropriate quantitative tools in a regulated drug development environment. Strong understanding of model-informed drug development (MIDD) and its application in shaping regulatory strategy. Involvement in clinical projects for both small molecules and biologics. Preparation of strategic regulatory communications and development of reports and summary documents. Proficiency in pharmacometrics software tools for non-linear mixed effects modeling, data manipulation and preparation, physiologically based pharmacology, and systems pharmacology modeling. Proficient in MS Office Suite. Working Conditions: Requires up to 10% domestic and international travel The anticipated salary for this position will be $155,000 to $170,000. Kyowa Kirin North America provides a comprehensive range of benefits including: 401K with company match Discretionary Profit Share Annual Bonus Program Generous PTO and Holiday Schedule Healthcare Benefits Well-Being and Work/Life Programs Life & Disability Insurance Long Term Incentive Program Pet Insurance Tuition Assistance Employee Referral Awards Kyowa Kirin North America is an equal employment opportunity employer and does not discriminate on the basis of race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status.

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