Pharmacometrics Senior Manager

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