Executive Director, Clinical Pharmacology Job at Bayside Solutions, Fremont, CA

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  • Bayside Solutions
  • Fremont, CA

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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Job Tags

Full time, For contractors,

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