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 will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to 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 or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

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