Director, Pharmacometrics

Gilead Sciences•Foster City, CA

About The Position

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 You will lead quantitative analyses in the Oncology, Inflammation and Virology Therapeutic Areas of Gilead Sciences, Inc.. These analyses will include all stages of drug development from first-in human through Phase IV clinical trials. You will be responsible for the conduct as well as interpretation and reporting of the analyses, and support of regulatory filings. You will champion model-informed drug development (MIDD) across drug discovery and development and serve as a subject matter expert for modeling and simulation to cross-functional partners.

Requirements

PhD or equivalent degree in engineering, pharmaceutical sciences, pharmacology, or related discipline with 8+ years’ relevant pharmacometrics research or development experience OR Masters or equivalent degree in engineering, pharmaceutical sciences, pharmacology, or related discipline with 10+ years’ relevant pharmacometrics research or development experience OR Bachelors or equivalent degree in engineering, pharmaceutical sciences, pharmacology, or related discipline with 12+ years’ relevant pharmacometrics research or development experience.

Nice To Haves

Significant experience working on, with, and leading cross-functional project/program teams in life sciences.
Extensive experience in pharmacometrics leading and authoring modeling and simulation plans and having responsibility for the scientific execution of related analyses across Phase I – IV studies.
Demonstrated excellence in effectively managing multiple pharmacometrics analyses deliverables and priorities through matrix management and leadership.
Relevant experience in the Oncology, Virology, and/or Inflammation Therapeutic Areas.
Proficiency in mathematics
Demonstrated ability to be a fast learner.
Demonstrated ability to be flexible and adaptable to change
Recognized for sustained scientific excellence.
Extensive knowledge of quantitative analyses as well as the physiological/pharmacological aspects of drugs.
Strong communication and organizational skills.
Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams and executives.
When needed, ability to travel.

Responsibilities

Leading quantitative and innovative strategies within clinical pharmacology to impact MIDD during the life cycle of the program
Evaluate and apply state-of-the-art quantitative pharmacology approaches for clinical pharmacology decision-making and for global regulatory submissions, including INDs, IBs, NDAs, BLAs, MAAs, and pediatric plans in collaboration with key stakeholders. Evaluate and apply strategy and content as appropriate.
Guide dose regimen/optimization strategies in partnership with other therapeutic area leads and clinical pharmacology leads to enable data-driven decisions
Develop high-quality modeling and simulation strategy and content: author/review/approve modeling and simulation analysis plans and outputs, interpretation, and presentation of key findings to regulators and to stakeholders as needed.
Ensure adherence to agreed timelines and budgets to ensure prompt and accurate execution of deliverables from clinical pharmacology studies and programs.
Develop and present training within and outside the department as needed

Benefits

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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