Principal Clinical Pharmacologist, Clinical Pharmacology

We are looking for a Principal Clinical Pharmacologist in our Pharmacometrics (PMx) group. This individual is expected to provide significant contributions to PMx deliverables in support of multiple programs. With an understanding of the program strategy, the Pharmacologist provides PMx contributions that support this strategy. This person is further able to prospectively provide PMx contributions in support of longer-term development strategies executed over the course of multiple experiments, studies, and/or clinical trials. Additionally, this person independently conducts or otherwise oversees the development of PMx analysis plans.

A TYPICAL DAY MIGHT LOOK LIKE:
- Prospectively designs and conducts quantitative or other PMx analyses of a sophisticated nature that is consistent with and supportive of the program development strategy for one or more program.

- As a PMx Program Representative, with limited mentorship 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.

- Is responsible for the preparation and timely delivery of accurate study reports was well as regulatory submission documents as appropriate.

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

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

- Contributes to and/or leads technical working groups, providing support for process improvement initiatives.

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

- Actively publishes work in scientific literature.

REQUIREMENTS
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.