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Staff Scientist, Quantitative Pharmacology

Regeneron Pharmaceuticals

This is a Contract position in Town Of Mount Pleasant, NY posted April 23, 2019.

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions.

Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary As an individual contributor in the Quantitative Pharmacology department, this position will provide population and mechanism-based modeling and simulation as well as other quantitative methodologies in support of strategic decision-making in drug development programs.

This support is hands-on in nature and spans drug development from the late non-clinical research activities through BLA submission and post-marketing commitments, as well as across Regeneron’s portfolio.

More experienced individuals will also be expected to provide technical mentorship to junior scientists.

Responsibilities Develop and execute quantitative strategies in collaboration with the cross functional development project teams (to include Clinical Pharmacology, Biostatistics, Clinical Sciences, and Regulatory Affairs) that advance the portfolio by addressing critical development program questions Using population based modeling methodologies develop exploratory Pop PK and PK/PD models to aid in research and development programs spanning early non-clinical pharmacology efforts through clinical phase 3 dose-selection and BLA dose justification Develop population PK and PK/PD covariate models to support global regulatory activities and market access applications.

Develop mechanistic PK, PKPD, exposure-response and disease models to support on-going clinical development programs from early clinical development through market application and post-marketing commitments.

Establish and execute a variety of non-population based quantitative pharmacology analyses as appropriate to best address the needs of an on-going development program Work with colleagues within Clinical Pharmacology, Preclinical PK, Toxicology and Early and Late-Stage Clinical Development to provide appropriate quantitative pharmacology support for FIH dose selection and study design Provide technical and subject matter expertise to the clinical project team on matters relating to quantitative pharmacology Expand the Quantitative Pharmacology and modeling & simulation capability through evaluation, implementation, and publication of new data analysis techniques, software, computational infrastructure, personal technical skill, as well as the strategic application of quantitative pharmacology and population based M&S methodologies across the development portfolio Work cooperatively and synergistically with the other members in the Quantitative Pharmacology function and across the organization Requirements Education Ph.D in pharmaceutical sciences (PKPD concentration), mathematics, engineering, or other related disciplines Experience Relevant experience (3 years) in applied population PK, PK/PD modeling & simulation, and quantitative pharmacology in the pharmaceutical industry Skilled in state of the art and innovative methods of population PK and PK/PD modeling using NONMEM, R, MONOLIX etc., and/or experienced in the mathematical description and numerical solution of biological systems to address complex life sciences problems Expertise in population analysis methodologies (NONMEM preferred) This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry.

Apply today and learn more about Regeneron’s unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening.

All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place.

In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.”,”title”:”Staff Scientist, Quantitative Pharmacology SDL2017