Quantitative Medicine Scientist - Pharmacometrics

Job Description
ABOUT CRITICAL PATH INSTITUTE

Founded in 2005, we are an independent nonprofit that is a catalyst in the development of new approaches to advance medical innovation and regulatory science. We orchestrate the development of actionable solutions through an innovative, collaborative approach to the sharing of data and expertise. Dedicated to advancing regulatory science opportunities outlined in the FDA's Critical Path Initiative, we have forged global partnerships and created collaborations that include the FDA, European Medicines Agency (EMA), and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) as well as private industry.

Our ongoing success is due to a combination of public and private support for our vision, as well as the dedicated team of employees that we have. Each and every employee is valued as a member of the team - they are much more than a number. We provide a great work environment that people love being a part of!

Job Title: Quantitative Medicine Scientist

The position of Quantitative Medicine Scientist (QMS) is part of the C-Path's QuantMed Program. The QMS is responsible for pharmacometrics modeling and simulation activities required to support model-informed drug development (MIDD) strategies, including the interpretation, reporting, and communication of results in the form of internal and external presentations, regulatory submissions, and peer-reviewed manuscripts. Quantitative science is a rapidly evolving discipline, and in addition to pharmacometrics the QMS is expected to have the ability, or aptitude to learn, and provide support to at least one additional discipline within QuantMed program: biostatistics, applied mathematics, or artificial intelligence.

Qualifications:

PharmD, Ph.D., or equivalent degree in chemical or biomedical engineering; applied mathematics; quantitative pharmaceutical sciences or related field (2 years of experience or postdoctoral training is strongly preferred preferred)

• Proficiency or experience working in team settings.

Essential Job Duties and Responsibilities:

• Collaborate with multi-disciplinary teams within C-Path to generate key knowledge to inform quantitative strategies
• During the planning stages, works with internal and external teams to ensure principles of MIDD are considered and applied
• Communicate with internal and external data managers and analysts to deliver modeling and exploratory analysis subsets
• Conduct statistical and visual data summarizations and exploratory analyses
• With guidance, develop modeling analysis plans to support quantitative strategies
• Conduct hands-on work on fit-for-purpose mathematical models (disease progression, placebo effect, drug effect, and PK/PD) by applying quantitative pharmacology principles
• Summarize and effectively articulate important findings to internal C-Path consortia team members and actively participate in discussions supporting drug development solutions
• Preparation of scientific summaries and reports for regulatory submissions and publications.
• Proficiency in R programming language and hands-on experience using NONMEM, Monolix, or Phoenix NLME to develop nonlinear mixed-effects models is required
• Highly motivated and self-driven with the ability to perform well in team settings and independently
• High degree of flexibility and adaptability to cross several therapeutic areas and handle multiple projects
• Ability to meet target deadlines and manage time effectively, balanced across multiple projects.
• Demonstrates a thorough understanding of, or aptitude to learn, one or more additional quantitative methods used in drug development: 1) statistical modeling, (survival models, Bayesian methods): 2) applied mathematics (signal processing, time-series analysis, mechanistic models for biological systems), 3) artificial intelligence (image analysis, natural language processing, speech analytics)
• Knowledge of clinical pharmacology and drug development
• Communication: demonstrates ability to effectively present quantitative results, development plans, and strategies to technical and non-technical audiences in verbal form
• Writing: demonstrates ability to write results, interpretations (including impact) and conclusions for reports and regulatory documents that are clear and concise.

Physical Demands:

• Regularly required to sit for long periods of time, and occasionally stand and walk about the facility.
• Regularly uses hands to operate computer equipment and other office equipment.
• Close vision required for computer usage.
• Occasionally required to stoop, kneel, and lift 25 pounds.

Travel on occasion for out-of-town meetings (~ 10%).

In accordance with the Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors, C-Path has adopted a policy to comply with this requirement all C-Path employees must vaccinated to safeguard the health of our employees and their families; our customers and visitors; and the community at large from COVID-19.

Reasonable Accommodation:

Newly hired employees in need of an exemption from this policy due to a medical reason or because of a sincerely held religious belief must submit a completed request for accommodation form to the human resources department to begin the interactive accommodation process as soon as possible. Accommodations will be granted where they do not cause C-Path undue hardship or pose a direct threat to the health and safety of others. Please direct any questions regarding this policy to the human resources department.

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