Principal Scientist, PKPD/QSP Modeling & Simulation

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Job description

The successful candidate will work within the Biomedicines Design Preclinical Modeling and Simulation team. As a member of multidisciplinary project teams, the candidate will influence the quality of decisions made in preclinical biotherapeutic programs with the use of quantitative mechanism based PKPD models. Therapeutic areas include oncology, immunology and inflammation, internal medicine (including metabolic diseases) and rare diseases. Modalities range from monoclonal antibodies to gene therapies.

Responsibilities:

• Collaborate with multidisciplinary project teams to develop and implement mechanistic mathematical models of pharmacology to aid in target selection, target prioritization, therapeutic modality selection, chemical/biotherapeutic optimization, biomarker characterization and early clinical trial design
• Liaise with research biology/pharmacology to help in the development of in-vitro assays and in-vivo models to generate data that inform preclinical-to-clinical, translational PKPD models
• Provide leadership within project teams to design, execute and interpret quantitative pharmacology studies
• Collaborate and maintain an active relationship with Clinical Pharmacology and Pharmacometrics at the project level as well as in the advancement of modeling and simulation sciences
• Network as appropriate with global experts in the department and other groups to share learnings and enhance consistency in best practices across sites, disease areas, and therapeutic approaches
• Keep up to date with emerging literature and science in the mechanistic modeling and simulation sciences
• Continue to build a personal track record of publication in the area of PKPD modeling and simulation and contribute to PDM's external publication/presentation goals consistent with our increased investments in the area of modeling and simulation

Basic Qualifications:

• Ph.D. degree in mathematics, engineering or other disciplines related to quantitative pharmacology or equivalent experience with a strong emphasis on biopharmaceutical modeling and simulation required.
• 2-3 years of pharmaceutical industry or related experience in developing and applying mechanism based PKPD models to guide project teams from early discovery to early clinical development
• Excellent understanding of theory, principles and statistical aspects of advanced mathematical modeling and simulation
• Sound understanding of the principles of pharmacokinetics (non-compartmental, compartmental, PBPK)
• Ability to effectively translate/condense/summarize outcomes of modeling and simulation analyses into useable information for multidisciplinary project teams
• Good team player and communicator
• Good listener and ability to effectively interact with colleagues with a variety of backgrounds
• Keen to interact as a modeling and simulation expert with matrix project teams working closely with within departmental as well as biology, protein engineering and clinical scientists
• Strong belief that modeling and simulation can have a significant positive impact on research projects
• In depth, hands-on knowledge of the state-of-the-art modeling and simulation software with (NONMEM, MATLAB, Simbiology, Phoenix, Berkeley-Madonna, R or comparable applications)
• Ability to learn new areas of biological sciences and build on solid foundation of quantitative skills to develop mechanistically relevant PKPD models
• Ability to keep up to date with and propose the implementation of scientific and technological developments in the area of PKPD modeling and simulation
• Motivated to develop a career as a hands-on, technical modeling and simulation expert in a preclinical drug discovery environment
• Committed to sharing technical expertise and the development of self and others

Preferred Qualifications:

• 4-5 years of pharmaceutical industry or related experience in developing and applying mechanism based PKPD models to guide project teams from early discovery to early clinical development
• Experience in working in the oncology disease area
• Experience with novel biotherapeutic modalities (bispecifics, Fc-fusions and other targeting agents)

Other Job Details:

• Role can be based onsite in La Jolla CA or Cambridge MA
• Eligible for Employee Referral Bonus
• Eligible for Relocation

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Research and Development

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