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:

Education
Ph.D. or PharmD degree in Pharmacometrics, Bioengineering, Systems Pharmacology, Mathematics, Applied Statistics, Computer Science

Experience
•    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.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company match
• Discretionary Profit Share
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Life & Disability Insurance
• Concierge Services
• Long Term Incentive Program (subject to job level and performance)
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States