Director, Pharmacometrics

仕事内容

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.

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

Basic 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.

Preferred Requirements:

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.