strategic and scientific job, responsible for quality of modeling work being performed at Regeneron. This person will apply state of the art modeling and simulation (M&S) approaches to influence designs and internal/external decision making across the portfolio. We expect this person to develop and apply quantitative frameworks that enable model-informed drug discovery and development (MIDD) across Regeneron. In addition, this position will ensure quantitative rigor and quality results through direct scientific mentorship
- Accountable for developing a culture encouraging of MIDD approaches at Regeneron, influencing key partners, stakeholders and regulators of its value and application
- Accountable for planning and executing state-of-the-art M&S techniques with direct value for projects cross the portfolio
- Scientific and strategic input into pre-clinical, clinical, and post-approval development plans
- Accountable for oversight, support and delivery of scientific and strategic modeling work related to specific projects
- Support evaluation of drug candidates for in/out-licensing
- Accountable for the identification and development of drug-disease models and other modeling approaches to support internal and external decision making in collaboration with partners (when relevant)
- Accountable to provide peer review and mentoring of junior staff
- Support and contribute to the development of the quantitative pharmacology in terms of providing training and knowledge sharing
- Monitoring external and internal environment in terms of relevant new methodologies and applications
- Increase Regeneron profile externally in the area of MIDD by speaking at external events and by publication in recognized external journals
- Ensure Regeneron modeling efforts are aligned with current regulatory expectation
- Partner with the Preclinical Pharmacokinetic/Pharmacodynamics Team to enable translational PKPD efforts in the Discovery space
This position requires a PhD in Pharmaceutical Sciences (PKPD emphasis), Statistics, Engineering or other quantitative subject areas. 15 years validated experience in the application of QP in a drug discovery/development setting including experience in developing PhD modelers is required. This experience should include noteworthy expertise in M&S, including PK, PKPD and Statistics. Broad Translational and Clinical development expertise in drug development (early and late), with emphasis on Pharmacometrics is required.
The candidate will have an international reputation gained from publishing in the field on Pharmacometrics as well as a track record of identifying, developing and executing portfolio-level M&S activities and disease domain knowledge.
A confirmed knowledge of Regulatory, compliance, processes, standards and Pharmacometrics issues as well as Regulatory experience (written/oral) 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.