Senior Clinical Pharmacology Leader: PK/PD Modeling

Xyzagen, Inc.; Pittsboro (NC); On-site; USD 120,000 - 156,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with Safe Harbor match

Paid time off

Job summary

Xyzagen, Inc. seeks an Associate Director of Clinical Pharmacology to lead design, execution, and interpretation of clinical pharmacology studies (Phase I–III) and to develop quantitative pharmacometric strategies for dose selection and regulatory submissions.

The role supports both biologics and small molecules, with in vitro ADME exposure for small molecules and bioanalytical PK/ADA work for large molecules, while collaborating across NIH-funded startups to mid-sized pharma clients.

Qualifications

• Advanced degree in clinical pharmacology or related field.
• 5–8 years of experience in clinical pharmacology or pharmacometrics.
• Deep understanding of FDA, EMA, ICH guidelines and their application to programs.
• Experience with PK/PD modeling and simulation software.
• Experience in design and interpretation of clinical pharmacology studies (Phase I–III).
• Experience in in vitro ADME assays for small molecule development is a plus.

Responsibilities

• Lead the design, execution, and interpretation of clinical pharmacology studies (Phase I–III).
• Develop and implement quantitative pharmacometric strategies for dose selection and regulatory submissions.
• Provide strategic drug development and regulatory consulting to a diverse client base.
• Author and review regulatory sections of INDs, NDAs, and Investigator Brochures.
• Translate complex pharmacometric data into clear development strategies for clients.
• Represent Xyzagen as a subject matter expert in client meetings and business development.
• Supervise associate scientists and scientists within the team.
• Assist with business development and client engagement.

Skills

Clinical pharmacology

Pharmacokinetics

Regulatory strategy

Dose selection

Pharmacometric modeling

Cross-functional leadership

Education

MS/PhD/PharmD/MD in Clinical Pharmacology or related field

Tools

Phoenix WinNonlin

NONMEM

R

Monolix

Job description

Xyzagen, Inc. seeks an Associate Director of Clinical Pharmacology to lead design, execution, and interpretation of clinical pharmacology studies (Phase I–III) and to develop quantitative pharmacometric strategies for dose selection and regulatory submissions.

The role supports both biologics and small molecules, with in vitro ADME exposure for small molecules and bioanalytical PK/ADA work for large molecules, while collaborating across NIH-funded startups to mid-sized pharma clients.