Associate Director, Clinical Pharmacology & PK Modeling

Xyzagen, Inc.; North Carolina; Hybrid; USD 120,000 - 156,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with Safe Harbor match, profit 

Two weeks of paid time off

Company-paid holidays

Job summary

Xyzagen, Inc. in Pittsboro, NC is seeking an Associate Director of Clinical Pharmacology to lead design, execution, and interpretation of Phase I-III studies and to develop quantitative pharmacometric strategies for dose selection and regulatory submissions.

The role supports both small and large molecule programs, may involve in vitro ADME, PK/PD modeling, and cross-functional leadership across early and late-stage development teams.

Qualifications

• Advanced degree required in clinical pharmacology, pharmacokinetics or related field.
• 5–8 years of progressive clinical pharmacology/pharmacometrics experience in pharma/biotech.
• Strong regulatory knowledge (FDA/EMA/ICH) and experience with regulatory documents.
• Experience in PK/PD modeling and simulation software.

Responsibilities

• Lead the design, execution, and interpretation of clinical pharmacology studies (Phase I-III).
• Develop quantitative pharmacometric strategies to support dose selection and regulatory submissions.
• Provide strategic drug development and regulatory consulting to diverse clients.
• Author and review regulatory sections (INDs, NDAs, Investigator Brochures).
• Represent Xyzagen in client meetings and business development initiatives.

Skills

Leadership

Strategic thinking

Communication

Cross-functional collaboration

Education

MS, PhD, PharmD, or MD in Clinical Pharmacology, Pharmacokinetics, or related discipline

Tools

Phoenix WinNonlin

NONMEM

R

Monolix

Job description

Xyzagen, Inc. in Pittsboro, NC is seeking an Associate Director of Clinical Pharmacology to lead design, execution, and interpretation of Phase I-III studies and to develop quantitative pharmacometric strategies for dose selection and regulatory submissions.

The role supports both small and large molecule programs, may involve in vitro ADME, PK/PD modeling, and cross-functional leadership across early and late-stage development teams.