We are looking for a Principal Pharmacokineticist that will support PK and PK/PD (PPK/PD) requirements for Discovery and IND-stage project teams. Efforts include providing PK and PK/PD input/oversight and direction to early preclinical/nonclinical in vivo studies, interfacing with TFA scientific staff performing the preclinical studies and directing/managing non-clinical PK studies, preparing and presenting the PK/PD analyses to internal project teams and senior management, and writing summary reports and documents to support regulatory filings.
A day in the life of the Principal Scientist may look like:
Serve on Discovery-stage project teams as a subject matter authority for Preclinical Pharmacokinetics / Pharmacodynamics, providing input to the design of preclinical PK/pharmacology studies.
Collaborate optimally with various groups within Regeneron, including Therapeutic Proteins, Therapeutic Function Areas, Assay Development, Precision Medicine, Preclinical Operations and PPK/PD management developing a PK strategy for each project and then delivering the required output.
Effectively communicate project team queries, requests and expectations (i.e. timing and results) from the Project Teams to management.
Conduct and report PPK/PD analyses using data derived from preclinical (nonclinical) studies.
Work in close association with the Toxicology, Pathology, Clinical Pharmacology (CP) and Quantitative Pharmacology (modeling & simulation) functions, within the Drug Safety and Pharmacometrics (DSP) Department, to deliver the required data and study reports / regulatory documents to support project progression.
Maintain an up-to-date knowledge of the relevant scientific literature as well as regulatory guidance and best practices as they pertain to PPK/PD.
We feel this might be the role for you if:
You want to work in a fast-paced, highly collaborative culture
You have a passion for science and want to help bring new drugs to people in need
You want exposure to multiple Therapeutic areas and new modalities
To be considered qualified we require:
A PhD in Pharmacology, Pharmacokinetics, Biology/Molecular Biology or Biochemistry, with > 5-8 years of relevant, proven experience (Biotech or Pharma).
An in-depth theoretical and applied understanding of PK and PD, in order to describe and understand the pharmacology/biology of therapeutic proteins; experience with other modalities including siRNA and CRISPR based therapeutics, and cell therapies would be extremely beneficial
A proven track record to plan, coordinate and lead all aspects of PK and/or PK/PD studies and analyze PK/PD data.
Excellent communication (written/verbal), presentation, influencing and leadership skills
Knowledge of and experience with relevant PK/PD software applications (e.g., WinNonLin) is desirable, as is experience in drafting PK reports and relevant IND sections.
Previous experience with protein/monoclonal antibody therapeutics and new modalities in one or more of the following therapeutic areas: oncology, inflammation / immunology, metabolism, infectious disease or ophthalmology.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
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At Regeneron we believe that when the right idea finds the right team, powerful change is possible. As we work across our expanding global network to invent, develop and commercialize life-transforming medicines for people with serious diseases, we’re establishing new ways to think about science, manufacturing and commercialization. And new ways to think about health. Connect with us so we can learn more about you, and you can learn more about our biopharmaceutical medicines. And join us, as we build a future we believe in. Please visit www.regeneron.com/social-media-terms for information on how to engage with us on social media. An important note about privacy: Regeneron is committed to your privacy and will not ask for sensitive personal information such as social security number, date of birth or bank account details via email or social media.
