Job Description

Executive Director, Clinical Pharmacology

Direct Hire Full-Time Role

Salary Range: $239,200 - $260,000 per year

Location: Redwood City, CA - Hybrid Role

Job Summary:

As the Executive Director of Clinical Pharmacology and Pharmacometrics, you will be responsible for bioanalysis, pharmacokinetics, clinical pharmacology, population PK, PKPD, exposure-response, and disease/translational modelling and simulation for our studies. In this role, you will work closely with CRO colleagues to ensure the appropriate implementation of model-informed drug development (MIDD).

Duties and Responsibilities:

• Clinical pharmacology, pharmacokinetics, and pharmacometrics SME who applies state-of-the-art modelling and simulation (M&S) approaches to influence study design and decision making.
• Provide scientific and strategic input into pre-clinical and clinical development plans and clinical studies.
• Operational leadership of clinical pharmacology
• Help design, facilitate, and supervise modeling work performed by external contractors.
• Conduct preliminary WINNONLIN PK analysis when needed.
• Conduct emerging data analyses as needed and/or review, interpret, and help report M&S results from contractors.
• Contribute to regulatory documents and interactions.
• Support DMPK and bioanalytical (BA) aspects of clinical and nonclinical studies as needed.
• Help develop mechanistic drug-disease models.
• Help develop and facilitate BA, PK, and pharmacometric data management and archiving processes.
• Work in compliance with Good Clinical Practice (GCP) regulations

Requirements and Qualifications:

• PhD or equivalent in clinical pharmacology, pharmacokinetics, or pharmacometrics
• 10+ years of pharmaceutical industry experience in drug discovery and development
• Expert knowledge of PK/PD and pharmacometric analyses and modeling using software such as WINNONLIN, R, NonMem, SAS, SIMCYP
• PK/pharmacometric lead in oncology and clinical pharmacology studies, with Hematological Malignancy experience preferred
• Excellent oral and written communication skills
• Experience with writing Clinical Pharmacology NDA submissions

Desired Skills and Experience

Clinical Pharmacology, Pharmacometrics, bioanalysis, pharmacokinetics, population PK, PKPD, exposure-response, disease modelling, translational modelling, M&S, drug discovery, WINNONLIN, R, NonMem, SAS, SIMCYP, oncology, Hematological Malignancy, NDA submission

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