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. 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.

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 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.

Requirements

• 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.
• Have extensive knowledge base of the work in overall scientific community in own discipline.
• 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.

Qualifications

• A PhD and 10+ 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.
• Proven experience developing Quantitative Pharmacology elements of regulatory strategy and interacting with regulatory agencies without supervision.
• Strong publication record in the field.

Work location

Tarrytown, NY, Warren, NJ, or Cambridge, MA

Hybrid: 4 days per week on site

Pay

Salary range (annually): $205,000.00 – $341,600.00