- Regeneron Pharmaceuticals, Inc.
- Yonkers, New York
- Start date
- Mar 22, 2023
- Clinical, Clinical Research
- Required Education
- Position Type
- Full time
- Pharm Country, Best Places to Work
We are looking for a Clinical Pharmacologist. This individual will plan, design, implement and analyze in-vivo and in-vitro pharmacokinetic & pharmacodynamic studies working with CP, QP, PPK-PD, Toxicology, Bioanalytical, Therapeutic Focus Areas and Clinical Development / Regulatory
We expect this individual to contribute to the scientific understanding of PK/PD for assigned projects, based on quantitative evaluation of the pharmacokinetic and pharmacodynamic profile for research programs, through the application of pharmacokinetics and pharmacodynamics.
A day in the life of a Principal Clinical Pharmacologist may look like:
• Plans, designs, implements and analyzes routine PMx studies to advance scientific knowledge, in collaboration with other team members.
• Performs analyses such as NCA, compartmental modeling, PopPK, translational modelling, disease modelling, Pop PK/PD, E-R analyses.
• Works to prepare TFLs to support IND/CTA, PK WSs, Tox WS, Pharm WS, CSRs, DSURs, IB and other documents. Collaborates with Scientific Writing (and where appropriate with PMx Stats Programming team) to ensure TFLs for PMx reports are complete.
• With close supervision from senior PMx staff, supports preparation of material to be used in regulatory interactions. Preparation of PMx materials for regulatory background packages, e.g. for pre-IND, EOP2, and pre-BLA meetings is also in scope. Performs additional analyses as required to support regulatory interactions.
•Works in conjunction with Scientific Writing, QC and QAA (as required) to issue study reports in support of IND/CTA submissions and other regulatory documents.
• Actively publishes work in scientific literature
This may be the right role for you if:
• You want to participates in technical working groups, providing support for process improvement initiatives.
• You enjoy working in cross-functional teams with forward-thinking, passionate, driven teammates
In order to be considered qualified for this role you must:
Have a minimum of a PhD and experience with PMx concepts and techniques. We expect this experience to include advanced pharmacokinetics, advanced pharmacological principles, non-compartmental analysis methods. Experience in Exposure-Response analysis methods, translational modelling/pharmacology, Nonlinear Mixed Effects modeling, logistic regression, survival analysis, Bayesian approaches, disease modelling/QSP are also advantageous.
#ASCPTDoes this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)$102,200.00 - $163,200.00
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
- Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
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