Director of PK/PD Modeling & Regulatory Strategy

Scorpion Therapeutics

Berkeley Heights (NJ)

On-site

USD 180,000 - 240,000

Full time

12 days ago
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Job summary

Scorpion Therapeutics is seeking a Director of Quantitative Clinical Pharmacology to lead population PK/PD modeling to support BioNTech's drug development pipeline. You will oversee PK/PD modeling, translational analyses, and dose selection strategies across programs.

The role requires a PhD/MD/PharmD with 8+ years in biotech/pharma, hands-on PK/PD modeling, regulatory submission experience, and strong leadership.

Qualifications

  • Hands-on PK/PD modeling and regulatory submission experience.
  • Experience managing external vendors.
  • Strong leadership and communication skills.
  • Translational modeling to inform dose decisions in programs.

Responsibilities

  • Lead PK, ER, and PK/PD modeling activities.
  • Drive translational modeling to inform dose decisions.
  • Support regulatory submissions (IND, NDA/BLA).
  • Mentor junior staff and establish best practices.

Skills

PK/PD modeling
Regulatory submissions
Leadership
Communication
Modeling software

Education

PhD/ PharmD/ MD in pharmaceutics/pharmacokinetics or related field

Tools

NONMEM
R
Phoenix WinNonlin
MATLAB

Job description

Scorpion Therapeutics is seeking a Director of Quantitative Clinical Pharmacology to lead population PK/PD modeling to support BioNTech's drug development pipeline. You will oversee PK/PD modeling, translational analyses, and dose selection strategies across programs.

The role requires a PhD/MD/PharmD with 8+ years in biotech/pharma, hands-on PK/PD modeling, regulatory submission experience, and strong leadership.

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