Director Quantitative Pharmacology

Job description

Role Overview

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

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 the 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, with extensive knowledge of the work in the overall scientific community in your discipline.

Are recognized as an expert in your area within the organization.

Have extensive regulatory experience through authoring of regulatory briefing books, CTD summaries, contributions at HA meetings, HA negotiations, and approvals of BLA or equivalent.

Make decisions guided by policies, procedures and business plan; receive guidance from the head of function.

Qualifications

In order to be considered qualified for this role, you must have a PhD and 10+ years with a degree in Quantitative Pharmacology (Pharmacometrics) or a 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 the ability to communicate complex information succinctly.

Proven experience developing QP elements of regulatory strategy and interacting with regulatory agencies without supervision.

Salary

$205,000.00 - $341,600.00 annually

Equal Opportunity Employer

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.

#J-18808-Ljbffr

Who can apply

Review the original listing for work authorization, qualifications and employer requirements.