Director, Clinical Pharmacology- Inflammation
About The Position
As a Director within the Clinical Pharmacology Group at Gilead, you will have significant responsibility and accountability for clinical pharmacology programs in Inflammation. 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. This is an site based role at our global headquarters in Foster City, CA.
Requirements
- At least 8 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.)
- 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
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 new clinical pharmacology 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
- 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
- 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
Benefits
- company-sponsored medical, dental, vision, and life insurance plans
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
