Director, Quantitative Clinical Pharmacology

Scorpion Therapeutics; Berkeley Heights (NJ); On-site; USD 180,000 - 240,000; Full time

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

Role

Director of Quantitative Clinical Pharmacology focusing on population PK/PD modeling to support BioNTech's drug development pipeline.

Responsibilities

• lead and supervise PK, ER, and PK/PD modeling activities using tools like NONMEM, R, Phoenix WinNonlin, MATLAB; drive translational modeling to inform dose decisions; manage external vendor collaborations; support regulatory submissions (IND, NDA/BLA); provide strategic insights for program development; mentor junior staff and establish best practices.

Qualifications

• Ph.D., Pharm.D., or M.D. in pharmaceutics, pharmacokinetics, or related field; minimum 8 years of biotech/pharma experience with hands-on PK/PD modeling and regulatory submission expertise; proficiency in modeling software; experience managing external vendors; strong leadership and communication skills.

HighValue

biotechnology/pharmaceuticals, population PK/PD modeling, regulatory filings, cross-functional leadership, oncology experience preferred.

WorkSetup

multiple US locations; details on remote/hybrid not specified.