Senior Director, Clinical Pharmacology & PK/PD Strategy

Clinical Dynamix, Inc.; South San Francisco (CA); On-site; USD 200,000 - 260,000; Full time

Job summary

Clinical Dynamix, Inc. is seeking a highly motivated scientist to design clinical studies and perform PK/PD analyses. The role involves interpreting results and reporting findings to support drug development decisions and regulatory filings.

The candidate will lead PK/PD modeling efforts across Phase I–III and collaborate with multiple internal teams and external partners. The position reports to the SVP of Clinical Development and requires deep expertise in pharmacometrics, regulatory science,

Qualifications

• Ph.D. with 12+ years in Clinical Pharmacology or related field.
• Strong background interpreting non-clinical/clinical dose-response and PK/PD data.
• Regulatory guidance related to clinical pharmacology experience.
• Proficiency with PK/PD analysis software (WinNonlin, NONMEM, Phoenix NLME).

Responsibilities

• Oversee and support a portfolio of clinical assets.
• Design Phase I studies and collaborate with clinical teams to select PK sampling strategies.
• Perform, supervise, and report PK and PK/PD analyses as assets progress through development.
• Integrate pharmacokinetic, pharmacodynamic, and safety data from multiple sources to optimize dosing.
• Interact with cross-functional teams to ensure timely study completion and regulatory filings.
• Contribute to protocol sections, analysis plans, and study reports for regulatory documents.

Skills

PK/PD analysis

Regulatory guidance understanding

Independent leadership

Education

Ph.D. in Pharmaceutics/Pharmacology/Pharmacokinetics or PharmD

Tools

WinNonlin

Phoenix NLME

NONMEM

Job description

Clinical Dynamix, Inc. is seeking a highly motivated scientist to design clinical studies and perform PK/PD analyses. The role involves interpreting results and reporting findings to support drug development decisions and regulatory filings.

The candidate will lead PK/PD modeling efforts across Phase I–III and collaborate with multiple internal teams and external partners. The position reports to the SVP of Clinical Development and requires deep expertise in pharmacometrics, regulatory science,