Director Quantitative Pharmacology

Regeneron Pharmaceuticals; United States; Remote; USD 202,000 - 337,000; Full time

Job summary

An established industry player is seeking a Director in Pharmacometrics to lead quantitative analyses for research and development programs. In this pivotal role, you will manage a portfolio of products, ensuring timely delivery of high-quality reports and analyses while communicating complex information effectively. Your expertise in pharmacokinetics, pharmacodynamics, and regulatory strategies will be crucial in shaping the future of drug development. Join a diverse and inclusive culture that values your contributions and offers comprehensive benefits, including wellness programs and equity awards, as you embark on this exciting journey in the pharmaceutical field.

Benefits

Health and Wellness Programs

Fitness Centers

Equity Awards

Annual Bonuses

Paid Time Off

Qualifications

• PhD +8 years in Quantitative Pharmacology or related field required.
• Expertise in PK/PD principles and regulatory experience necessary.

Responsibilities

• Manage PK/PD evaluations for a portfolio of products.
• Ensure high quality and accuracy of analyses and documentation.
• Communicate complex information succinctly to management.

Skills

Pharmacokinetics

Pharmacodynamics

Quantitative Pharmacology

Interpersonal Communication

Regulatory Strategy

Education

PhD in Quantitative Pharmacology

Related Field

Tools

Quantitative Tools and Systems

Job 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:

1. Manages and is accountable for the PK/PD evaluation of a small portfolio of products or projects.
2. Works independently, with guidance in only the most complex situations.
3. Informs PMx management of important program and regulatory developments in a timely manner.
4. Ensures analyses and documentation are of the highest quality and accuracy.
5. Ensures that reports and other documents have the appropriate messaging and that a meaningful “story-line” is developed.
6. Ensures that study reports and other documents have an appropriate functional review and are suitable for review by senior management.
7. Solves complex problems; takes a broad perspective to identify solutions.
8. Has a strong publication record and actively publishes work in scientific literature.
9. Makes contributions to multi-disciplinary meetings by sharing cross-functional skills and knowledge.
10. 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:

1. 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.
2. 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 own discipline.
3. Are recognized as an expert in your own area within the organization.
4. Have extensive regulatory experience through authoring of regulatory briefing books, CTD summaries, contributing at HA meetings, HA negotiations through regulatory reviews and approvals of BLA or equivalent.
5. Make decisions guided by policies, procedures and business plans; receive guidance from the 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.

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.

Salary Range (annually)

$202,000.00 - $336,600.00