Director/Principal Scientist I, Clinical Pharmacology

Location
Foster City, CA
Posted
Jun 26, 2022
Ref
2990946
Required Education
Doctorate/PHD/MD
Position Type
Full time

As a Director/Principal Scientist I within the Clinical Pharmacology Group at Gilead, you will have significant responsibility and accountability for clinical pharmacology programs in Virology.

As a member of the Clinical Pharmacology team you will have unparalleled opportunity to be involved with every aspect of the product development process, from first-in human through approval, including post-marketing activities. In this role, you will have the advantage of providing input into a breadth of products within and across your area of responsibility. We seek to provide a fun and rewarding career and a continuous learning experience.

Responsibilities:
  • Leading clinical pharmacology studies of the highest complexity
  • Providing strategic leadership and demonstrating accountability for the clinical pharmacology programs supporting Phase 1-4 clinical development for development compounds in your therapeutic area
  • Developing and implementing clinical pharmacology and pharmacometric/modeling and simulation tools and technologies to drive smarter drug development for programs.
  • 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
  • Supervising, developing and mentoring junior level scientists, both direct reports and via matrix structure in clinical pharmacology teams
  • Authoring/reviewing/approving 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
  • Maintaining and establishing relationships and agreements with contract vendors
  • Evaluating departmental and broader organizational SOPs as fit for purpose, in compliance with current scientific standards and regulatory requirements
  • Ensuring adherence to agreed timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs
  • Understanding the impact of decisions and actions on the business and consulting with colleagues and management as applicable
  • Participating in and collaborating with individuals from across the business in special projects
  • Developing and presenting training within and outside the department


Education and Experience:
  • At least 8+ years' of experience and a PhD, PharmD or MD degree with emphasis in clinical/quantitative pharmacology, pharmacokinetics or a related scientific discipline
  • In-depth knowledge and expertise with pharmacokinetic analysis and modeling and simulation software programs (WinNonlin, NONMEM, S-Plus/R, etc)
  • Experience in developing and implementing clinical pharmacology and modeling/simulation strategies for small/large molecule/novel modality drug development
  • Thorough knowledge of current and emerging scientific standards regulatory requirements for assigned territories
  • Excellent written and oral communication skills and ability to convey complex technical information clearly
  • Confidence and ability to present to and influence senior leaders
  • 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



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