Principal, Quantitative Pharmacology

Tarrytown, NY, United States
Apr 01, 2021
Required Education
Position Type
Full time
We are looking for a Principal Scientist in our Pharmacometrics (PMx) Group. This individual is expected to provide significant contributions to PMx deliverables in support of multiple programs. We expect this person will be to prospectively provide PMx contributions towards longer-term development strategies executed over the course of multiple experiments, studies, and/or clinical trials. The Principal Scientist independently conducts or otherwise oversees the development of PMx analysis plans and applies standardized or advanced scientific techniques to conduct PK, PD, and/or other types of quantitative analyses. Additionally, they are responsible for the preparation and timely delivery of an accurate and well-articulated study reports was well as regulatory submission documents as appropriate.

- Prospectively designs and conducts quantitative or other PMx analyses of a complex nature or otherwise appropriate that is consistent with and supportive of the program development strategy for one or more program.

- On program teams, effectively communicate PMx results in colloquial terms that are understandable across the development teams.

- With limited guidance from PMx management is responsible for, authoring PMx contributions to regulatory documentation, such as IB's, as well as briefing document for; pre-IND, EOP2, and other global Health Authority (HA) meetings.

- Contributes accurate tables and figures for inclusion in slides for senior management presentations.

- Is able to independently draft and review documentation for accuracy, clarity and messaging to ensure documents are appropriate for further PMx management review.

- With some supervision, competently represents PMx at pre-IND, Type C, preBLA, and HA meetings.

- Contributes to and/or leads new/revised SOPs and cross-functional workstreams.

- Actively publishes work in scientific literature.

To be considered for this opportunity, you must have an advanced degree in pharmaceutics, biology, engineering, pharmacy (Pharm. D.), or Medicine (MD) combined with proven experience or in CP or clinical PK/PD, in industry. We need someone who can analyze and assess PK/PD data and utilize PK/PD software (WinNonlin, R, NONMEM, Monolix) proficiently. Prior experience in PK and PK/PD of large molecules and/or RNA therapeutics is helpful. CP experience in one or more Therapeutic Focus Areas is desired.
Does 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 amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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.