Regeneron is seeking an experienced Preclinical Pharmacokinetics scientist who is well versed in the application of pharmacokinetics / pharmacodynamics (PK/PD), in order to describe and understand the pharmacology/biology of therapeutic proteins.
The candidate will represent the Preclinical Pharmacokinetics and Pharmacodynamics (PPK/PD) group on cross-functional Discovery project teams and be an advocate for the use of quantitative approaches to describe the relationship between the known physiology and the observed pharmacokinetics of candidate drug molecules.
This role will involve providing PK and PK/PD input into early preclinical in vivo studies, interfacing with scientific staff performing these studies, and preparing and presenting the PK/PD analyses to internal project teams and (potentially) senior management.
This role will require a high level of collaboration across various functions within Regeneron; thus, the candidate must have the ability to influence, make decisions and have strong communication and leadership skills.
The candidate will be expected to share his/her opinions, ask and answer challenging questions, and demonstrate tenacity, all in the context of excellent science, as Regeneron continues to create innovative new medicines.
• Serve on Discovery-stage project teams as a subject matter expert for Preclinical Pharmacokinetics/ Pharmacodynamics, providing PK or PK/PD input to the design of preclinical PK/pharmacology studies.
• Collaborate effectively with various groups within Regeneron, including Therapeutic Proteins, Therapeutic Function Areas, Assay and Biomarker development, Preclinical Operations and PPK/PD management in order to develop a PK strategy for each project and then deliver the required output.
• Effectively communicate project team queries, requests and expectations (i.e. timing and deliverables) from the Project Teams to staff and management.
• Conduct and report PK and PK/PD analyses using data derived from preclinical studies.
• Work in close association with the Toxicology, Pathology, as well as Clinical Pharmacology (CP) and Quantitative Pharmacology (modeling & simulation) functions, within the Drug Safety and Pharmacometrics (DSP) Department.
• Maintain an up-to-date knowledge of the relevant scientific literature as well as regulatory guidances and best practices as they pertain to PPK/PD.
PhD in Pharmacology, Pharmacokinetics, Biology/Molecular Biology, Biochemistry or related Life-Science, with at least 6+ – 8+ years of relevant experience.
• Previous experience with protein/ monoclonal antibody therapeutics in one or more of the following therapeutic areas - oncology, inflammation / immunology, metabolism, infectious disease or ophthalmology
• In-depth theoretical and applied understanding of PK and PD, in order to describe and understand the pharmacology/biology of therapeutic proteins.
• Demonstrated ability to plan, organize, oversee PK and/or PK/PD studies, and analyze PK/PD data
• Excellent communication (written/verbal), presentation and leadership skills
• Knowledge of and experience with relevant PK/PD software applications (eg, WinNonLin,) is desirable.
• Demonstrated scientific creativity is required, together with the ability to propose innovative solutions.
• Experience in writing PK reports, PK written summaries and contributing to IND's is desirable.
About Regeneron Pharmaceuticals
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.