Pharmacometrics Manager

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.

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 conducting, interpreting and reporting the analyses, and supporting 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.

• Lead quantitative and innovative strategies within clinical pharmacology to impact MIDD throughout the program life cycle.
• Evaluate and apply state‑of‑the‑art quantitative pharmacology approaches for clinical decision‑making and global regulatory submissions (INDs, IBs, NDAs, BLAs, MAAs, pediatric plans) in collaboration with key stakeholders.
• Guide dose regimen / optimization strategies with therapeutic area leads and clinical pharmacology leads to enable data‑driven decisions.
• Develop high‑quality modeling and simulation strategy and content: author, review, approve analysis plans and outputs, interpret results, and present key findings to regulators and stakeholders.
• Ensure adherence to agreed timelines and budgets for accurate delivery of clinical pharmacology deliverables.
• Develop and deliver training within and outside the department as needed.

• PhD or equivalent degree in engineering, pharmaceutical sciences, pharmacology, or related discipline with 0+ years relevant pharmacometrics research or development experience.
• OR Masters or equivalent degree in the same fields with 6+ years relevant experience.
• OR Bachelors or equivalent degree with 8+ years relevant experience.

• 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 being responsible 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, 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 ability to effectively communicate project direction and status to varied organizational levels, including leadership teams and executives.
• Willingness to travel as needed.

The salary range for this position is: $ - $. Base compensation is determined by experience, qualifications, and geographic location. This role may be eligible for discretionary…