Pharmacometrics Senior Manager
Scorpion Therapeutics, San Francisco, California, United States, 94199
Role Summary
You will lead quantitative analyses in the Oncology, Inflammation and Virology Therapeutic Areas of Gilead Sciences, Inc. across all stages of drug development from first-in-human through Phase IV clinical trials. You will be responsible for the conduct, interpretation and reporting of the analyses, and support 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 Qualifications
Required: PhD or equivalent degree in engineering, pharmaceutical sciences, pharmacology, or related discipline with 0+ years’ relevant pharmacometrics research or development experience Required: Masters or equivalent degree in engineering, pharmaceutical sciences, pharmacology, or related discipline with 6+ years’ relevant pharmacometrics research or development experience Required: Bachelors or equivalent degree in engineering, pharmaceutical sciences, pharmacology, or related discipline with 8+ years’ relevant pharmacometrics research or development experience Preferred: Significant experience leading cross-functional project/program teams in life sciences Preferred: Extensive experience in pharmacometrics leading and authoring modeling and simulation plans and scientific execution of analyses across Phase I–IV studies Preferred: Experience in Oncology, Virology, and/or Inflammation Therapeutic Areas Preferred: Proficiency in mathematics Preferred: Fast learner and adaptable to change Preferred: Sustained scientific excellence and strong communication and organizational skills Preferred: Ability to travel when needed Skills
Strong ability to communicate project direction and status to leadership and executives Education
PhD, or Master’s, or Bachelor’s degree in engineering, pharmaceutical sciences, pharmacology, or related discipline (as per above) Additional Requirements
When needed, ability to travel
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You will lead quantitative analyses in the Oncology, Inflammation and Virology Therapeutic Areas of Gilead Sciences, Inc. across all stages of drug development from first-in-human through Phase IV clinical trials. You will be responsible for the conduct, interpretation and reporting of the analyses, and support 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 Qualifications
Required: PhD or equivalent degree in engineering, pharmaceutical sciences, pharmacology, or related discipline with 0+ years’ relevant pharmacometrics research or development experience Required: Masters or equivalent degree in engineering, pharmaceutical sciences, pharmacology, or related discipline with 6+ years’ relevant pharmacometrics research or development experience Required: Bachelors or equivalent degree in engineering, pharmaceutical sciences, pharmacology, or related discipline with 8+ years’ relevant pharmacometrics research or development experience Preferred: Significant experience leading cross-functional project/program teams in life sciences Preferred: Extensive experience in pharmacometrics leading and authoring modeling and simulation plans and scientific execution of analyses across Phase I–IV studies Preferred: Experience in Oncology, Virology, and/or Inflammation Therapeutic Areas Preferred: Proficiency in mathematics Preferred: Fast learner and adaptable to change Preferred: Sustained scientific excellence and strong communication and organizational skills Preferred: Ability to travel when needed Skills
Strong ability to communicate project direction and status to leadership and executives Education
PhD, or Master’s, or Bachelor’s degree in engineering, pharmaceutical sciences, pharmacology, or related discipline (as per above) Additional Requirements
When needed, ability to travel
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