Director, Clinical Pharmacology - Virology

For Current Gilead Employees And Contractors

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At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.

As a Director within the Clinical Pharmacology Group at Gilead, you will have ultimate responsibility and accountability for clinical pharmacology programs for the Virology therapeutic area. As a key 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.

Key Responsibilities

• Participating in and collaborating with individuals from across the business in special projects
• Developing and maintaining collaborative working relationship with colleagues within and outside the department
• Be pivotally involved in the hands-on analysis and interpretation of clinical PK/PD data, integrating clinical trial simulation strategies and disseminating the relevant risk/benefit implications to the Company's project development teams
• Representing the department and providing subject matter expertise on cross-functional project teams
• Developing and presenting training within and outside the department
• Function as the sole point of contact for all Clinical Pharmacology activities on projects at all stages of development (Ph1-4) and be able to influence team strategy using modelling expertise
• Providing strategic leadership and demonstrating accountability for the clinical pharmacology programs supporting Phase 1-4 clinical development for development compounds in your therapeutic area
• Understanding the impact of decisions and actions on the business and consulting with colleagues and management as applicable
• Supervising, developing, and mentoring junior level scientists, both direct reports and via matrix structure in clinical pharmacology teams
• Maintaining and establishing relationships and agreements with contract vendors
• Ensuring adherence to agreed timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs
• Leading clinical pharmacology studies of the highest complexity
• Developing high quality clinical pharmacology plans and content for global regulatory submissions, including INDs, IBs, NDAs, MAAs and pediatric plans
• Authoring/reviewing/approving clinical protocols, analysis plans, study reports and regulatory submissions
• Evaluating departmental and broader organizational SOPs as fit for purpose, in compliance with current scientific standards and regulatory requirements
• Developing and implementing new clinical pharmacology tools and technologies to drive smarter drug development for programs

Minimum Qualifications

• 8+ years of experience and a PhD, PharmD or MD degree with emphasis in Clinical Pharmacology, Pharmacokinetics or a closely related scientific discipline
• Excellent written and oral communication skills and ability to convey complex technical information clearly
• Thorough knowledge of current and emerging scientific standards regulatory requirements for assigned territories
• Ability to critically analyze problems and provide creative solutions
• Desire to strive for continuous improvement
• Confidence and discipline to work autonomously
• Proven track record of extensive experience in population modeling and simulations. Expertise with standard modelling and simulation software (NONMEM, S-Plus/R, etc) is required. Knowledge of other software – e.g. WinNonlin required
• Experience in developing and implementing clinical pharmacology and modeling/simulation strategies for novel modalities (example: mAbs, antibody drug conjugates, bi-specifics, cell therapy, etc.) and deliver lifesaving medicines
• Confidence and ability to present to and influence senior leaders
• Genuine curiosity and drive to ask questions – looking for the ‘why’ of every project

Preferred Qualifications

• Previous Virology therapeutic area experience

The salary range for this position is: $214,795.00 - $277,970.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For Additional Benefits Information, Visit

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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For Current Gilead Employees And Contractors

Please log onto your Internal Career Site to apply for this job.