About this role
Job title: Director, Quantitative Pharmacology
About the Role Director in Pharmacometrics (Quantitative Pharmacology) is accountable for the delivery of support for one or more R&D programs within the pharmacometrics discipline, ensuring timely and accurate quantitative analyses, interpretation, and messaging to PMx management, and well-constructed reports for PMx review.
What You'll Do
- Manage the PK/PD evaluation for a small portfolio of products or projects and deliver analyses, interpretation, and messaging to PMx management.
- Work independently, with guidance only in the most complex situations.
- Inform PMx management of important program and regulatory developments in a timely manner.
- Ensure analyses and documentation are of the highest quality and accuracy; develop a meaningful "story-line" in reports.
- Ensure study reports and documents have appropriate messaging and functional reviews and are suitable for senior management review.
- Be fully knowledgeable of pharmacokinetic/pharmacodynamic principles, pharmacology, biology, and quantitative aspects of drug development; possess deep understanding of scientific literature and PK/PD methods.
- Maintain an extensive knowledge base of work in the scientific community; have extensive regulatory experience through authoring regulatory briefing books, CTD summaries, HA meetings and negotiations, and approvals of BLA or equivalent.
- This role requires a PhD and 10+ years in Quantitative Pharmacology or related field; hands-on usage of a broad range of quantitative tools; a strong publication record.
- Proven experience developing quantitative pharmacology elements of regulatory strategy and interacting with regulatory agencies without supervision.
What We're Looking For
- PhD with 10+ years in Quantitative Pharmacology/Pharmacometrics or related field.
- Hands-on usage of a broad range of quantitative tools and systems; strong publication record.
- Experience developing PK/PD elements of regulatory strategy and interacting with regulatory agencies without supervision.
- Deep knowledge of PK/PD principles, pharmacology, biology, and quantitative drug development.
- Extensive regulatory experience including authoring regulatory briefing books, CTD summaries, HA meetings, and negotiations through reviews/approvals of BLA or equivalent.
- Strong communication and leadership skills with ability to deliver results in a fast-paced R&D environment.
Compensation & Benefits
- Salary range: $205,000 - 341,600 annually USD.
- Regeneron total rewards package may include bonuses or other incentive plans, equity awards, 401(k) company match, health/dental/vision/life and disability insurance, paid time off, and family support benefits.