Regeneron Pharmaceuticals
Director Quantitative Pharmacology
Regeneron Pharmaceuticals, Basking Ridge, New Jersey, us, 07920
Regeneron is seeking a Director to join our Pharmacometrics team!In this role, a typical day might include:As a Director in Pharmacometrics (Quantitative Pharmacology), this individual is accountable for the delivery of support for one or more research & development programs within their pharmacometrics discipline. In this capacity, the Director is accountable for the timely and accurate delivery of needed quantitative analyses, interpretation, and messaging to PMx management, as well as the timely delivery of well-constructed and well-messaged reports for PMx review.This role might be for you if you can:Manage and be accountable for the PK/PD evaluation of a small portfolio of products or projects.Work independently, with guidance in only the most complex situations.Inform PMx management of important program and regulatory developments in a timely manner.Ensure analyses and documentation are of the highest quality and accuracy.Ensure that reports and other documents have the appropriate messaging and that a meaningful “story-line” is developed.Ensure that study reports and other documents have an appropriate functional review and are suitable for review by senior management.Solve complex problems; take a broad perspective to identify solutions.Have a strong publication record and actively publish work in scientific literature.Make contributions to multi-disciplinary meetings by sharing cross-functional skills and knowledge.Have excellent interpersonal and communication skills, both written and oral, and the ability to communicate complex information succinctly.Have strong collaborative skills and be effective at building alliances across functions.Effectively influence colleagues and multi-disciplinary project teams.Able to handle all types of projects and leverage higher-level staff for technical input and brainstorming to implement solutions for complex projects. Able to work with considerable ambiguity.Identify business problems and work in a team to craft solutions. Able to interact with regulatory agencies without supervision, and with the company to develop regulatory strategy.Be active professionally and find ways to represent the company externally.To be considered for this opportunity, you must have the following:Be fully knowledgeable of pharmacokinetic/pharmacodynamic principles, pharmacology, biology, and quantitative aspects of drug development as well as having an advanced knowledge of pharmaceutical drug development.Possess a deep understanding of scientific literature and technical skills in a number of PK/PD methods and techniques. Have an extensive knowledge base of the work in the overall scientific community in your discipline.Be recognized as an expert in your area within the organization.Have extensive regulatory experience through authoring of regulatory briefing books, CTD summaries, contribution at HA meetings, HA negotiations through regulatory reviews and approvals of BLA or equivalent.Have decisions guided by policies, procedures, and business plans; receive guidance from the head of function.Hold a PhD with 8+ years of relevant experience.Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
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