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Senior Director, Clinical Pharmacology

Foster City, CA, USA | Gilead Sciences

  • Industry:
    Pharmaceutical / Biotech
  • Position Type:
  • Functions:
    General Management
  • Experience:
    10-12 years
Job Description:
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Job Description

As a Sr. Director within the Clinical Pharmacology Group at Gilead, you will have ultimate responsibility and accountability for clinical pharmacology programs in the area of HIV and emerging viral infections.

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(s)

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 maintainingcollaborative working relationship with colleagues within and outside the department

Supervising, developing and mentoring junior level scientists, both direct reports and via matrix structure inclinical pharmacologyteams

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;

10+ 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 (eg. 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

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