The Clinical Pharmacology Department at Gilead Sciences is looking for a proven leader to join our Quantitative Pharmacology team as the Director, Quantitative Pharmacology.
In this role you will provide broad, pharmacometrics strategic leadership for a team who supports model-based drug development and performs model-
based meta-analysis. This position will provide you opportunities for internal and external growth and leadership in both Pharmacometrics and Clinical Pharmacology.
At Gilead, it’s our employees’ dedication to science and the lives of patients living with life-threatening diseases around the world that motivates our team to success, discovery, & curiosity.
This is your opportunity to join our team as we are revolutionizing healthcare by bringing urgently needed medicines to patients in the unmet areas of HIV / AIDS, Immunology, Liver diseases, Hematology and Oncology, and more.
This individual will be responsible for :
Strategic leadership for the quantitative pharmacology team at Gilead in a way that drives success, efficiency, and innovation for the business helping Gilead to develop the next break through therapies.
Work with the department Clinical Pharmacology team and other cross-functional team members to help address key program and portfolio level questions.
Develop and implement pharmacometric analysis strategies to address key questions.
Ensure alignment of the pharmacometric analysis plan with the global clinical development plan.
Supervise, develop, and mentor junior level scientists, both direct reports and via matrix structure; in pharmacometric strategy, including reporting and interpreting pharmacometric analysis results.
Represent the department and provide your subject matter expertise on cross-functional project teams.
Contribute to Clinical Pharmacology regulatory submissions (pre- and post-approval).
Serve as an expert to internal colleagues across the organization and to external organizations such as government regulatory agencies.
Maintain and establish relationships and agreements with contract vendors.
Position Requirements :
Proven success leading and supporting an autonomous team.
Hands on expertise with Pop PK and PK / PD analyses. Physiological PBPK modeling desirable, but not essential (team can do this).
Ph.D., PharmD, and / or M.D. in biological / medical / pharmaceutical sciences, engineering, or a related field.
8+ years of experience (industry and / or academia) in pharmacometric analyses (e.g., population pharmacokinetics, exposure-
response, model-based meta-analysis, and disease progression) using modeling software like NONMEM, Matlab, S-PLUS / R and, SAS or similar software.
Excellent understanding of theory, principles and statistical aspects of advanced mathematical modeling and simulation.
Thorough understanding of the basic principles of pharmacokinetics and pharmacodynamics.
Ability to communicate internally and externally on topics related to Clinical Pharmacology, Pharmacometrics and Model-Based Meta-Analysis.
Ability to keep up-to-date with and propose the implementation of scientific and technological developments in Pharmacometrics.
Knowledge of current practices and issues in clinical pharmacology, bioanalytical, biopharmaceutics, and regulatory affairs would be a plus.