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Senior Quantitative Pharmacologist

Employer
Regeneron Pharmaceuticals, Inc.
Location
Boston, Massachusetts
Start date
Jun 14, 2024

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Discipline
Science/R&D, Pharmacology
Required Education
Doctorate/PHD/MD
Position Type
Full time
Hotbed
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Job Details

We are looking for a Senior Quantitative Pharmacologist to provide significant contributions in support of multiple programs. The person in this role is responsible for the execution of PK, PD, and other types of quantitative analyses that significantly contribute to the development these programs. The Senior Scientist should work collaboratively across the organization to, evaluate, design, select and apply standardized scientific techniques to analyze in-vivo and in-vitro pharmacokinetic & pharmacodynamic studies. We need this person for the preparation and timely delivery of accurate and well-articulated nonclinical or clinical study reports, and regulatory submission documents.

A typical day in the life of a Senior Quantitative Pharmacologist may look like:

  • In collaboration with other team members, and modest supervision; plans, designs, implements and analyzes results for a variety PMx studies.
    Performing a broad array of quantitative PK or PK/PD analyses such as but not limited to NCA, compartmental modeling, PopPK, translational modelling, disease modelling, Pop PK/PD, E-R analyses (or in close collaboration with Research Specialist or PMx Stats Programming team) to deliver PMx results. Works with supervision to develop interpretation and discussion of results.


    Works collaboratively with PMx Research Specialists, PMx Programming Team, Scientific and Writers, and/or other contributors to prepare TFLs in support of a number of internal or regulatory documents such as PK/PD study reports, IND/CTA, summary modules CSR, IB, etc. Works in conjunction with Scientific Writing, QC and QAA (as required) to complete final draft documentation in support of IND/CTA submissions and other regulatory documents.


    With mentorship from senior PMx staff, supports preparation of material to be used in regulatory interactions. Prepares PMx materials for regulatory background packages, e.g. for pre-IND, EOP2, and pre-BLA meetings. Performs additional analyses as required to support regulatory interactions.

This may be the right role for you if:

You have excellent interpersonal and communication skills both written and oral and ability to function Independently

Familiarity with regulatory/ research guidelines on drug development, (eg. ICH and GxP guidelines)

Want to work in an organization where data intimacy is valued
You are looking to make decisions independently for assigned studies or indication while proactively seeking line management intervention where needed to ensure successful outcome.

In order to be considered qualified, you must:

Have a minimum of a PhD and 3+ years of relevant experience. Experience should include an advanced understanding of quantitative concepts and techniques, including: non-compartmental analysis methods, compartmental modeling, translational modelling/pharmacology, Exposure-Responses analysis methods, Nonlinear Mixed Effects modeling, disease modelling/QSP*.


We expect experience with advanced PMx statistical methods and the applicability to clinical trials: such as survival analysis, stratified or covariate analyses and strategies for handling missing data, logistic regression, survival analysis, Bayesian approaches*.

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.

Salary Range (annually)

$124,200.00 - $202,800.00

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
US

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