Director - Translational PPK/PD
Job Posting for Director - Translational PPK/PD at Regeneron Pharmaceuticals Inc.
We are looking for a Director that is accountable for the delivery of Translational PK and PK/PD requirements. Scope includes Discovery and IND-stage project teams, particularly for newer modalities including siRNAs and CRISPR-based therapies, as well as gene & cellular therapies. In addition, this individual may be responsible for managing/mentoring a broad spectrum of individual contributing scientists.
A day in the life of the Director may look like:
- Serve on Discovery through early-Development stage project teams as a subject matter authority for Preclinical Pharmacokinetics / Pharmacodynamics, providing input to the design of preclinical PK/pharmacology and translational PK/PD studies.
- Collaborate effectively and influencing various groups within Regeneron, to develop 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 guidances and standard processes 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
In Order to be considered qualified you must have:
A PhD in Pharmacology, Pharmacokinetics, Biology/Molecular Biology or Biochemistry, with > 8 years of relevant, proven experience (Biotech or Pharma).
An in-depth theoretical and applied understanding of PK and PK/PD, in order to describe and understand the pharmacology/biology of therapeutic proteins and other modalities including siRNAs, CRISPR based therapeutics, gene and cell therapies. 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 our therapeutic areas.
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 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)
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