Associate Director, QSP & PK/PD Pharmacometrics - 2306158864W

　　Description

　　Janssen Research & Development L.L.C., a Johnson & Johnson company is recruiting for an Associate Director, QSP & PK/PD Pharmacometrics to be located in Spring House, PA.

　　At Janssen, we never stop working toward a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, and you can count on us to keep working tirelessly to make that future a reality for patients everywhere, by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Arterial Hypertension. Visit us: www.janssen.com

　　The Associate Director position is responsible for conducting mechanism-based PK/PD and quantitative systems pharmacology (QSP) modeling, with the aim to guide effective translation and development of clinical programs. Additional responsibilities may include pharmacometrics modeling and simulation activities for ClinPharm-sponsored and -supported studies for products in any phase of clinical development; the generation and review of clinical pharmacology and Pharmacometrics documents related to regulatory submissions, preparing responses to Agency questions and preparing for and/or attending meetings with Regulatory Agencies and Advisory Committee Meetings.

　　Key Responsibilities :

　　Support high impact product development projects in all stages of drug development using mechanism and physiologically-based PK/PD modeling & simulation methodologies, including Quantitative Systems Pharmacology (QSP) modelling, PBPK modelling, disease progression modelling and landscape analysis, etc.

　　Demonstrate high proficiency in the development and application of models to address drug-discovery and development questions

　　Perform exploratory modelling projects with quick turnaround to support critical business decisions

　　Provide leadership to and collaboration with multidisciplinary project teams to develop and apply QSP models

　　Supervise and actively participate in the review and monitoring of outsourced modeling activities conducted at Contract Research Organizations (CROs)

　　Guide and supervise junior scientists in the group

　　Serve as a point-of-contact person on QSP project teams, work in close collaboration with key Therapeutic Area stakeholders, clinical teams and related functional groups to maximize the value of mechanistic and QSP modeling.

　　Provide scientific and strategic expertise across therapeutic areas (Immunology, Oncology, Cardiovascular & Metabolism, Neuroscience, Infectious Diseases) and promote model-informed drug discovery and development strategies

　　Qualifications

　　Qualifications

　　Education:

　　Ph.D. degree in Pharmaceutical Sciences, Systems Biology/Pharmacology, Mathematics, Engineering, or other disciplines related to quantitative pharmacology or equivalentRequired :

　　At least 5 years of experience in using quantitative approach in describing biological systems and demonstrated ability to apply quantitative tools to enable rational and efficient drug development

　　Excellent understanding of theory, principles and statistical aspects of advanced mathematical modeling and simulation, including numerical methods, parameter estimation/optimization, and ordinary differential equations (ODEs), and how these can be applied in the development of complex models of biological pathways and systems

　　Proficient in at least one advanced PKPD modeling and simulation software (e.g. Matlab/Simbiology, Julia, Python, NONMEM, Monolix, etc.)

　　Self-motivated team player who excels in a collaborative, multi-disciplinary team environment

　　Good oral and written communication skills and the ability to interact effectively with scientists in other disciplines with a positive, collegial and collaborative attitude.

　　Preferred :

　　Experience in building, validating and using QSP models or deterministic models of biological pathways/systems to support basic science and/or translational clinical research strongly preferred

　　Good understanding of the basic principles of pharmacokinetics and pharmacodynamics for conventional large and small molecule therapeutics as well novel therapeutic modalities

　　Experience with general programming and data analysis tools/languages such as R would be particularly desirable

　　Strong publication record highly desirable

　　For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

　　Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability

　　Eligible for benefits to include medical, dental, vision and time off as well as any others as provided for in the applicable Collective Bargaining Agreement.

　　For additional general information on company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

　　Primary Location NA-US-Pennsylvania-Spring House

　　Organization Janssen Research & Development, LLC (6084)

　　Job Function Pharmacokinetics & Pharmacometrics

　　Req ID: 2306158864W