Staff/Sr. Staff Scientist, M&S, Quantitative Pharmacology

Regeneron Pharmaceuticals
Oct 18, 2016
Oct 19, 2016
Employer Type
Direct Employer
Employment Type
Full Time
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, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.


As a contributing member of the Quantitative Pharmacology function, individuals in this position will provide population based modeling and simulation as well as other quantitative methodologies in support of drug development programs. This support is meant to span development from the early non-clinical research activities through post-marketing commitments; as well as across Regeneron's portfolio.


+ 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

+ Develop population PK and PK/PD covariate models to support global regulatory activities and market access applications.

+ Develop mechanistic, 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 Clinical Development to provide appropriate quantitative pharmacology support for FIH dose selection and study design

+ Develop and execute quantitative strategies in collaboration with the cross functional development project teams to include Clinical Pharmacology, Biostatistics, Clinical Sciences, and Regulatory Affairs

+ 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 and implementation 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


+ Ph.D or Pharm.D. with a concentration in pharmacokinetics, pharmaceutical sciences, mathematics, engineering, or other related disciplines.

+ 7+ year relevant Industry experience in population PK, PK/PD modeling & simulation, and quantitative pharmacology in the pharmaceutical industry (Prospective applicants with
+ Highly independent and able function effectively with multiple activities across a broad corporate portfolio.

+ Highly skilled in state of the art and innovative methods of population PK and PK/PD modeling using NONMEM, R, MONOLIX etc.

+ Able to create and validate NONMEM or other Analysis Sets (ADS)

+ Familiar with execution of Pop PK and PK/PD in a cluster or cloud environment

+ Highly experienced in the application of quantitative pharmacology activities in the clinical development of monoclonal antibodies or other therapeutic proteins.

+ Able to utilize classic both classic and population analysis methods to best assess a concentration/exposure response relationship

+ Derive a preclinical population base PK model from available preclinical data; using appropriate allometric scaling support clinical dose selection for first in human SAD and MAD studies.

+ Using a population based approach, develop PK and PK/PD models from clinical PK, efficacy and PD/biomarker data to support further dose selection, dosing regimens, and dose ranging throughout clinical development, leading to phase 3 dose selection and a proposed labeled dose.

+ Experienced in global submission of population PK analysis and analysis data sets.

+ Experienced in the handling of high frequency pharmacology data.

+ Experienced in drafting and finalizing population PK and PK/PD reports, regulatory summary documents, responses to global health authority inquiries, and other regulatory documents.

+ Experienced in a variety of quantitative approaches to drug development.

+ Hands on experience in population modeling and simulation.

+ Possess strong scientific and technical expertise in the application of quantitative pharmacology and population PK modeling in drug development.

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. 4de22bfb512e4baa345b976