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Sr. Clinical Pharmacologist II

United States - California - Foster CityClinical Development & Clinical OperationsRegular

Job Description

As a Sr. Clinical Pharmacologist II, you will have responsibility and accountability for clinical pharmacology programs at Gilead in Oncology and Immuno-Oncology therapeutic area. You will have unparalleled opportunity to be involved with several aspects the product development process.  From first-in human through approval and post-marketing activities, you will provide input into a breadth of products within Immuno-Oncology.  We seek to provide a rewarding career and a continuous learning experience.

Responsibilities

  • Leading complex clinical pharmacology studies
  • Providing leadership and demonstrating accountability for the clinical pharmacology programs supporting Phase 1-4 clinical development for development compounds in your therapeutic area(s)
  • Representing the department and providing subject matter expertise on cross-functional project teams
  • Developing and maintaining collaborative working relationship with colleagues within and outside the department
  • Mentoring junior level scientists, including direct reports or supporting team members
  • Authoring/reviewing clinical protocols, analysis plans, study reports and regulatory submissions
  • Developing high quality clinical pharmacology plans and content for global regulatory submissions, including INDs, IBs, NDAs, MAAs and pediatric plans
  • Ensuring adherence to agreed timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs
  • Participating in and collaborating with individuals from across the business in special projects
  • Developing and presenting training within and outside the department


 

Education

  • 7+ years’ experience and a PhD, PharmD or MD degree with emphasis in clinical pharmacology, pharmacokinetics, or a related scientific discipline
  • In-depth knowledge of pharmacokinetic and other analysis software programs (e.g. WinNonlin, GraphPad, etc.)
  • Knowledge of current and emerging scientific standards regulatory requirements
  • Excellent written and oral communication skills and ability to convey complex technical information clearly
  • Ability to critically analyze problems and provide creative solutions
  • Confidence and discipline to work autonomously
  • Genuine curiosity and drive to ask questions – looking for the ‘why’ of every project
  • Desire to strive for continuous improvement