Director Quantitative Pharmacology

About the Role

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. The Director ensures the timely and accurate delivery of quantitative analyses, interpretation, and messaging to PMx management, as well as well-constructed and well-messaged reports for PMx review.

Responsibilities

• 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 appropriate messaging and a meaningful storyline.
• Ensures study reports and other documents undergo appropriate functional review and are suitable for senior management review.
• Applies deep knowledge of pharmacokinetic/pharmacodynamic principles, pharmacology, biology, and quantitative aspects of drug development.
• Utilizes advanced knowledge of pharmaceutical drug development and scientific literature, along with technical skills in PK/PD methods and techniques.
• Leverages extensive regulatory experience, including authoring regulatory briefing books, CTD summaries, and contributions at health authority (HA) meetings, negotiations, and reviews for BLA or equivalent approvals.

Requirements

• PhD and 10+ years of experience in Quantitative Pharmacology (Pharmacometrics) or a related field.
• Hands-on experience with a broad range of quantitative tools and systems, along with a strong publication record in the field.
• Proven experience developing Quantitative Pharmacology elements of regulatory strategy and interacting with regulatory agencies without supervision.

Work Location

Tarrytown, NY, Warren, NJ, or Cambridge, MA. Hybrid schedule: 4 days per week on-site.

Pay

Salary Range (annually): $205,000.00 - $341,600.00.

Benefits

Regeneron offers a competitive and comprehensive total rewards package, which may include:

• Annual bonuses or other incentive plans.
• Equity awards.
• Pension or retirement benefits, 401(k) company match.
• Health and wellness programs, fitness centers.
• Insurance benefits (e.g., medical, dental, vision, life, and disability).
• Paid time off and family support benefits.

For additional information about Regeneron benefits in the U.S., visit Regeneron Total Rewards. For other locations, details will be provided during the recruitment process.