Description

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.

A day in the life of a Director may look like:

· Manages and is accountable for the PK/PD evaluation of a small portfolio of products or projects.

· Works independently, with guidance in only the most complex situations.

· Informs PMx management of important program and regulatory developments in a timely manner.

· Ensures analyses and documentation are of the highest quality and accuracy.

· Ensures that reports and other documents have the appropriate messaging and that a meaningful “story-line” is developed.

· Ensures that study reports and other documents have an appropriate functional review and are suitable for review by senior management.

· Solves complex problems; takes a broad perspective to identify solutions.

· Has a strong publication record and actively publishes work in scientific literature

· Makes contributions to multi-disciplinary meetings by sharing cross-functional skills and knowledge.

· Has excellent interpersonal and communication skills, both written and oral, and has ability to communicate complex information succinctly.

This may be the right role for you if you:

· Are 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. Has extensive knowledge base of the work in overall scientific community in own discipline.

· Recognized as an expert in own 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.

· Decisions are guided by policies, procedures and business plan; receives guidance from head of function.

In order to be considered qualified for this role, you must have a PhD +8 years with a degree in Quantitative Pharmacology (pharmacometrics) or related field.

Hands on usage of a broad range of quantitative tools and systems is required, as is a strong publication record in the field.
A proven track record of displaying excellent interpersonal and communication skills both written and oral and ability to communicate complex information succinctly.
Proven experience developing QP elements of regulatory strategy and interacting with regulatory agencies without supervision.

#PMx

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.

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.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$205,000.00 - $341,600.00

Director Quantitative Pharmacology

Description

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