Description

Kartos Therapeutics is a privately held, clinical-stage biopharmaceutical company developing a potentially best-in-class MDM2 inhibitor. Launched in 2018 by proven industry veterans, we are a passionate team based in Redwood City, California and Bellevue, Washington. We have brought together scientists and clinicians with a deep understanding of hematology and oncology and an experienced leadership team. Together, we’re building an exciting biotechnology company with a culture defined by caring, ambition, dedication and teamwork!

Job Summary:

The Director/Sr Director of Clinical Pharmacology will be responsible for Kartos clinical pharmacology studies, population PKPD modeling and simulation (M&S), exposure-response analysis and regulatory interactions. In this role, the candidate will work closely with Kartos and CRO colleagues to ensure appropriate strategy and execution of clinical pharmacology studies and model-informed drug development (MIDD).

Responsibilities:

Clinical pharmacology, pharmacokinetics and pharmacometrics SME who applies clinical pharmacology regulatory strategy and M&S approaches to influence study design and decision making.

• Scientific and strategic input into pre-clinical and clinical development plans
• Operational leadership of Kartos clinical pharmacology studies
• Help design and supervise modeling work performed by external contractors
• Interpretation and reporting of M&S results
• Contribute to regulatory documents and interactions
• Support DMPK and bioanalytical aspects of both clinical and nonclinical studies as needed
• Work in compliance with Good Clinical Practice (GCP) regulations

Requirements

Qualifications:

PhD, PharmD, or equivalent in clinical pharmacology, pharmacokinetics, or pharmacometrics

• > ~10 years pharmaceutical industry experience in drug discovery and development
• Supervisory level experience with clinical PK/PD and pharmacometrics analyses and modeling using software such as WinNonlin, R, NONMEM, and SIMCYP
• PK/pharmacometrics lead in oncology and clinical pharmacology studies, with heme malignancy experience preferred
• Excellent oral and written communication skills