Senior Clinical Pharmacology Expert

1 day ago


Foster City, California, United States Gilead Sciences, Inc. Full time

Job Summary:

We are seeking a highly skilled Senior Clinical Pharmacologist to lead clinical pharmacology studies in the Virology therapeutic area. As a key member of our team, you will be responsible for designing and conducting clinical pharmacology studies, analyzing and interpreting data, and providing clinical pharmacology input into regulatory filings.

Key Responsibilities:

  • Design and conduct clinical pharmacology studies, including protocol development and study execution
  • Analyze and interpret data from clinical pharmacology studies, including PK-PD and related analyses
  • Provide clinical pharmacology input into regulatory filings, including clinical pharmacology plans and development plans
  • Collaborate with cross-functional teams, including research and development, regulatory, and clinical operations
  • Lead and manage small cross-functional project teams, including study concept and protocol design
  • Author clinical pharmacology development plans and modeling and simulation plans
  • Conduct PK-PD, Pop PK-PD, and related analyses, and contribute to regulatory filings, clinical publications, and presentations

Requirements:

  • PharmD or PhD in pharmaceutical sciences, pharmacology, or related discipline with 5+ years' relevant research or clinical experience
  • Relevant experience in Virology therapeutic area
  • Significant experience leading small cross-functional project teams in drug research or development
  • Significant experience leading study concept and protocol design, authoring clinical pharmacology development plans, and modeling and simulation plans
  • Proven effectiveness managing clinical project deliverables through matrix management
  • Experience supporting clinical publications and presentations is strongly preferred

Knowledge and Skills:

  • Demonstrated ability to be a fast learner
  • Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed
  • Recognized for sustained scientific excellence
  • Thorough knowledge of FDA and EMA regulations, ICH guidelines, and GCP governing the conduct of clinical studies
  • Has significant knowledge of pharmaceutical regulatory requirements related to clinical pharmacology
  • Has advanced knowledge of R&D and major disease areas, as evidenced by effectiveness supporting clinical projects
  • Demonstrable ability to effectively apply business acumen to strategic scientific projects
  • Significant knowledge of PK-PD, Pop PK-PD analyses and techniques and the physiological/pharmacological aspects of drugs
  • Able to serve as a clinical pharmacology specialist in authoring clinical pharmacology protocols, development plans, and modeling and simulation plans, conducting of PK-PD, Pop PK-PD, and related analyses, and literature and regulatory guidelines
  • Strong communication and organizational skills
  • When needed, ability to travel


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