Director Group Quantitative Pharmacology
Regeneron
7 days ago
Remote friendly (Tarrytown, NY)
United States
Clinical Research and Development
Director, Pharmacometrics (Quantitative Pharmacology)
Responsibilities:
- Deliver quantitative analysis, interpretation, and messaging to PMx management; ensure timely, accurate results.
- Produce well-constructed, well-messaged reports for PMx review.
- Manage and be accountable for PK/PD evaluation of a small portfolio of products/projects.
- Inform PMx management of important program and regulatory developments in a timely manner.
- Ensure analyses/documentation are high quality and accurate.
- Develop appropriate messaging and a meaningful “story-line” for reports/documents.
- Ensure study reports/documents undergo functional review suitable for senior management.
- Solve complex problems with a broad perspective.
- Contribute to multi-disciplinary meetings; share cross-functional skills/knowledge.
Qualifications:
- PhD.
- 10+ years with a degree in Quantitative Pharmacology (Pharmacometrics) or related field.
Required/Preferred Skills:
- Advanced knowledge of pharmacokinetic/pharmacodynamic principles, pharmacology/biology, and quantitative drug development.
- Deep understanding of scientific literature; strong PK/PD methods and techniques; strong publication record.
- Recognized expert in own area within the organization.
- Extensive regulatory experience (e.g., regulatory briefing books, CTD summaries, HA meetings/negotiations; BLA-equivalent).
- Proven written and oral communication skills; ability to communicate complex information succinctly.
- Hands-on usage of quantitative tools/systems.
- Proven experience developing QP elements of regulatory strategy; ability to interact with regulatory agencies without supervision.
Benefits/Compensation & Application:
- Benefits may include health/wellness programs (medical/dental/vision/life/disability), fitness centers, 401(k) match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves.
- Salary range (annually): $205,000.00 - $341,600.00.
- Apply now.
Responsibilities:
- Deliver quantitative analysis, interpretation, and messaging to PMx management; ensure timely, accurate results.
- Produce well-constructed, well-messaged reports for PMx review.
- Manage and be accountable for PK/PD evaluation of a small portfolio of products/projects.
- Inform PMx management of important program and regulatory developments in a timely manner.
- Ensure analyses/documentation are high quality and accurate.
- Develop appropriate messaging and a meaningful “story-line” for reports/documents.
- Ensure study reports/documents undergo functional review suitable for senior management.
- Solve complex problems with a broad perspective.
- Contribute to multi-disciplinary meetings; share cross-functional skills/knowledge.
Qualifications:
- PhD.
- 10+ years with a degree in Quantitative Pharmacology (Pharmacometrics) or related field.
Required/Preferred Skills:
- Advanced knowledge of pharmacokinetic/pharmacodynamic principles, pharmacology/biology, and quantitative drug development.
- Deep understanding of scientific literature; strong PK/PD methods and techniques; strong publication record.
- Recognized expert in own area within the organization.
- Extensive regulatory experience (e.g., regulatory briefing books, CTD summaries, HA meetings/negotiations; BLA-equivalent).
- Proven written and oral communication skills; ability to communicate complex information succinctly.
- Hands-on usage of quantitative tools/systems.
- Proven experience developing QP elements of regulatory strategy; ability to interact with regulatory agencies without supervision.
Benefits/Compensation & Application:
- Benefits may include health/wellness programs (medical/dental/vision/life/disability), fitness centers, 401(k) match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves.
- Salary range (annually): $205,000.00 - $341,600.00.
- Apply now.