Director, Modeling and Simulations - DMPK
Global Blood Therapeutics, Inc. (GBT) is seeking A Director, Modeling and Simulations to support Research (DMPK, Pharmacology and Toxicology) Non-Clinical PK-PD by developing predictive PK-PD models designed to inform dose and dosing regimen throughout the nonclinical testing program. The candidate will also identify opportunities for modeling and simulation for projects and be responsible for integrating and analyzing internal and external data to support interpretation and decision making for project teams with regards to study design, dose selection and extrapolation to other populations, such as pediatric subjects. The candidate may also support population PK, population PK/PD modeling and simulations, as well as exposure-response modeling and disease state modeling. Essential Duties and
Responsibilities:
Supports Clinical Pharmacology as required by developing PK-PD models to inform dose and dosing regimen optimization Leverages knowledge and understanding of the use of interspecies scaling methods and PBPK to translate results across species and predict a suitable dose and schedule in first in human clinical studies Uses mathematical models to describe interactions of the drug candidate with targets over the treatment period, and possible interactions with co-medications Duties include but are not limited to writing technical reports, communicating study results and interpretation to project teams, providing documents for regulatory submissions, presenting data at scientific meetings and author/review manuscripts for submission to peer reviewed journals Works in close partnerships across various functions, including Research, Clinical Development, and Regulatory to identify and advance clinical development candidates Represent DMPK group in multidisciplinary project teams Present data at internal cross-functional team and department meetings, and external conferences
Qualifications:
A minimum of 9-14
years of relevant work experience in applying quantitative modeling to analyze preclinical and clinical data is required. A PhD in, Pharmaceutical Sciences, Biomedical Engineering, Mathematics or Biostatistics is required. Equivalent experience may be accepted. Experience with small molecules is a must. Post-doctoral work may serve as experience. Demonstrated success in technical proficiency, scientific and/or medical creativity, collaboration with others and independent thought. Must have sound knowledge of modeling principles and possess strong computational skills. Must be proficient in at least one of the following:
Phoenix/WinNonlin, Matlab, Gastroplus, Berkeley Madonna, Nonmem, Monolix or equivalent. Experience applying drug development science (e.g., ADME, PK and PK/PD methods and simulation, statistics, etc.) to streamline drug development is desirable The successful candidate will have published PK and/or PK-PD models in peer-reviewed journals and conference abstracts. Strong written and verbal communication skills are required; must be able to independently create high quality written reports and summary documents to support regulatory submissions. Fit with GBT culture:
Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE:
This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time at the Company's facilities. The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.
Salary Range:
$150K -- $200K
Minimum Qualification
Physical Sciences, Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities:
Supports Clinical Pharmacology as required by developing PK-PD models to inform dose and dosing regimen optimization Leverages knowledge and understanding of the use of interspecies scaling methods and PBPK to translate results across species and predict a suitable dose and schedule in first in human clinical studies Uses mathematical models to describe interactions of the drug candidate with targets over the treatment period, and possible interactions with co-medications Duties include but are not limited to writing technical reports, communicating study results and interpretation to project teams, providing documents for regulatory submissions, presenting data at scientific meetings and author/review manuscripts for submission to peer reviewed journals Works in close partnerships across various functions, including Research, Clinical Development, and Regulatory to identify and advance clinical development candidates Represent DMPK group in multidisciplinary project teams Present data at internal cross-functional team and department meetings, and external conferences
Qualifications:
A minimum of 9-14
years of relevant work experience in applying quantitative modeling to analyze preclinical and clinical data is required. A PhD in, Pharmaceutical Sciences, Biomedical Engineering, Mathematics or Biostatistics is required. Equivalent experience may be accepted. Experience with small molecules is a must. Post-doctoral work may serve as experience. Demonstrated success in technical proficiency, scientific and/or medical creativity, collaboration with others and independent thought. Must have sound knowledge of modeling principles and possess strong computational skills. Must be proficient in at least one of the following:
Phoenix/WinNonlin, Matlab, Gastroplus, Berkeley Madonna, Nonmem, Monolix or equivalent. Experience applying drug development science (e.g., ADME, PK and PK/PD methods and simulation, statistics, etc.) to streamline drug development is desirable The successful candidate will have published PK and/or PK-PD models in peer-reviewed journals and conference abstracts. Strong written and verbal communication skills are required; must be able to independently create high quality written reports and summary documents to support regulatory submissions. Fit with GBT culture:
Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE:
This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time at the Company's facilities. The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.
Salary Range:
$150K -- $200K
Minimum Qualification
Physical Sciences, Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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