Director, Clinical Pharmacology – Virology

As a Director 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. 

Your tasks and responsibilities will include:

• 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 
• 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 

Specific education, experience and skills required for this role:

• At least 8 years’ experience and a, PhD, PharmD or MD degree with emphasis in clinical pharmacology, pharmacokinetics or a related scientific discipline 
• At least 10 years’ experience and a Masters degree with emphasis in clinical pharmacology, pharmacokinetics or a related scientific discipline 
• At least 12 years’ experience and a Bachelors 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 
   

Preferred Qualifications:

• Previous Virology therapeutic area experience