Kyowa Kirin North America is hiring a

Sr. Manager- Pharmacometrics

Princeton, United States

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 areas of unmet need: oncology, nephrology, immunology and CNS/movement disorders. The North America organization includes two offices (in New Jersey and California) that focus on drug discovery, product development, and commercialization. Together, we work as a close-knit team to understand clinical needs and advance innovations that can have a profound impact on patient lives.

Summary:

The Senior Manager, Pharmacometrics will be responsible for performing hands-on analyses to support model informed drug development (MIDD) decision making for Kyowa Kirin’s biologics and small molecule assets. The Senior Manager will perform dataset programming, exploratory data analysis, and modeling and simulation analyses using their understanding of biology as applied to quantitative approaches and clinical pharmacology. The Senior Manager is expected to communicate effectively and clearly within Clinical Pharmacology, with cross-functional teams, and to external audiences in support of advancing the development pipeline. 

Essential Functions:

•    Generate modeling and simulations plans, and conduct population pharmacokinetic and exposure-response analyses 
•    Prepare modeling and simulations analyses reports and review pharmacometric components of regulatory submission documents
•    Build on the current standards for MIDD analyses for continued improvement of workflows and processes
•    Globally collaborate with cross-functional teams, and effectively communicate scientific MIDD strategies and results to a wide range of audiences, internally and externally

Requirements:

Education
Advanced Degree in related field (Ph.D., PharmD, or master’s) 

Experience
2-3 years of experience with nonlinear mixed effects modeling of pharmacokinetics (PK) and pharmacodynamics (PD), or a post-doctoral experience in related field
Experience using NONMEM and/or other modeling and simulations software 
Proficiency with R or Julia programming
Experience with mechanistic and/or translational PK/PD modeling and simulations a plus

Technical Skills
Proficiency in pharmacometric software tools for non-linear mixed effects modeling, data manipulation and preparation, physiologically based pharmacology, and systems pharmacology modeling.
Experience with Microsoft Office, including Word, Excel, Power 
Point, Project, Articulate, and ability to learn new systems. 

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.

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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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