Director, Clinical Pharmacology- Inflammation

Biopharma Careers; Foster City (CA); On-site; USD 226,000 - 293,000; Full time

Benefits offered by this job

Discretionary bonus

Stock-based incentives

Paid time off

Medical/dental/vision benefits

Job summary

Gilead Sciences is seeking a Director within the Clinical Pharmacology Group at our Foster City, CA headquarters. You will guide clinical pharmacology programs across inflammation, spanning from first-in-human studies to post-marketing activities.

The role offers strategic leadership, collaboration with multidisciplinary teams, and opportunities to develop novel tools and technologies to enhance drug development and regulatory submissions.

Qualifications

• At least 8 years’ experience in clinical pharmacology or related field.
• PhD, PharmD or MD required.
• Strong knowledge of regulatory standards.
• Excellent written and oral communication skills.
• Ability to present to senior leaders.
• Ability to work autonomously and drive results.

Responsibilities

• Lead clinical pharmacology studies of high complexity.
• Provide strategic leadership for Phase 1–4 programs.
• Develop and implement new tools and technologies to drive smarter drug development.
• Represent the department on cross-functional project teams.
• Author and review clinical protocols, analysis plans, study reports and regulatory submissions.
• Develop high-quality clinical pharmacology plans for global regulatory submissions, including INDs, NDAs, MAAs and pediatric plans.
• Evaluate SOPs for fit and compliance with scientific standards and regulatory requirements.
• Ensure adherence to timelines and budgets for deliverables.
• Understand the impact of decisions and consult with management.
• Participate in cross-business special projects.
• Develop and present training within and outside the department.

Skills

Clinical pharmacology

Pharmacokinetics

Regulatory science

Education

PhD, PharmD or MD in clinical pharmacology or related discipline

Tools

WinNonlin

GraphPad

Job description

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

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.

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
• 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

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
• 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

The salary range for this position is: $226,185.00 - $292,710.00. 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.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT

Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.