ABOUT CRITICAL PATH INSTITUTE (C-PATH)

Critical Path Institute (C-Path) is a nonprofit engaged in the creation of partnerships and innovative processes that improve human health by reducing the time, cost, and risk in developing and approving new therapies. For over ten years, we have partnered with industry and academic experts to advance technologies across the spectrum of medical product development from research to regulatory approval. As a leading nonprofit organization dedicated to fostering collaboration and promoting data sharing in the precompetitive space, C-Path has been at the forefront of numerous advances designed to get new treatments to patients quicker. Our continuing success is made possible by a combination of public and private support from those who share our vision to accelerate a path to a healthier world.

POSITION OVERVIEW

We are seeking a highly motivated and skilled Quantitative Medicine Scientist to join our team and develop and optimize AI/ML algorithms for wearables, sensor technologies, and image analysis to solve unmet needs in drug development. The ideal candidate will have a strong background in AI/ML, data processing, model building, image analysis, and clinical pharmacology.

SUPERVISORY RESPONSIBILITIES

None at this time.

CORE DUTIES/RESPONSIBILITIES

• Algorithm Development: Develop and optimize AI/ML algorithms for wearables, sensor technologies, and image analysis to solve unmet needs in drug development.
• Data Processing: Conduct processing and analysis of large datasets with a focus on ensuring data quality, accuracy, efficiency, and meaningful insights.
• Model Building: architect, develop, optimize, and assess the performance of quantitative models for diverse applications in various stages during drug development.
• Image Analysis: Implement/develop image analysis algorithms covering processes such as image recognition, segmentation, and feature extraction.
• AI/ML Interpretability: Emphasize the interpretability of AI/ML models using existing methodologies to ensure transparency and explain-ability of their predictions.
• Real-World Applications: Keep abreast with the real-world applications, their data sources, and data analysis methodologies to complement the traditional clinical trials for decision-making in drug development processes.
• Collaboration: Collaborate with multidisciplinary teams and subject matter experts (SMEs), both internally and externally, to develop algorithms fit for use in solving unmet needs in drug development
• Research: Keep abreast with fast-paced developments in the fields of AI/ML, sensor/digital technology, image analysis, and their regulatory landscape.
• Documentation: Maintain comprehensive documentation of algorithms, code, and project progress
• Communication: Communicate the progress and research findings effectively to diverse stakeholders and through publications
• Commitment to ongoing learning: Learn contextual concepts relevant to drug development solutions to inform AI/ML models.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• AI/ML Frameworks: Demonstrates thorough understanding of the artificial intelligence and machine learning frameworks.
• Sensor Technologies: Demonstrate a thorough understanding of the sensor technologies and data collection and processing from these technologies.
• Software: demonstrates thorough experience coding in formal and/or modeling software platforms.
• Communication: demonstrates the ability to effectively present quantitative results, development plans, and strategies to technical and non-technical audiences in verbal form
• Writing: demonstrates the ability to write clinical pharmacology results, interpretations (including impact), and conclusions for reports and regulatory documents that are clear and concise.
• Time Management: Ability to meet target deadlines and manage time effectively, balanced across multiple projects.
• Networking and Alliance Building: good interpersonal skills that ensure teamwork and productive interactions among diverse personalities/areas of expertise; ability to garner support and coordinate resources in support of consortia objectives.
• Innovation: constantly looking for new approaches and able to devise/apply new techniques in quantitative medicine, clinical pharmacology, and modeling and simulation.
• Courage with Decisiveness to Act: bias towards action to achieve goals; excitement, enthusiasm, and a sense of urgency with regard to the development of drug development tools.
• Values: Practice the highest level of integrity and core value system consistent with C-Path's core values.
• Clinical Pharmacology: knowledge of principles of PK, PK-PD, phase I-III studies of drug development, biopharmaceutics, pathophysiology, and therapeutics is desirable.
• Regulatory Knowledge: understanding of appropriate FDA, EMA, and ICH guidelines in the design of analysis plans is desirable.
• Statistical methodologies: Knowledge of, or aptitude to learn, quantitative methods used in drug development: 1) statistical modeling, (mixed-effects models, survival models, Bayesian methods) is a plus.

Computer Skills:

• Proficient in programming in at least one of the following: R/STAN, Python [preferred],
• Knowledge of cloud computing platforms
• Additional expertise with other quantitative tools (e.g., SIMCYP, GastroPlus, Matlab, Phoenix [Winnonlin, NLME], Stan, BUGS) or programming languages (e.g., C++, Java, Perl) a plus

Physical Demands:

• Regularly required to sit for long time periods, and occasionally stand and walk about the facility.
• Regularly uses hands to operate computer equipment and other office equipment.
• Close vision is required for computer usage.
• Occasionally required to stoop, kneel, and lift up to 25 pounds.
• Travel on occasion for out-of-town meetings (~ 10%).

REQUIRED EDUCATION AND EXPERIENCE

• PharmD, PhD, or MS with 3+ years of equivalent training or experience in statistics, biostatistics, applied mathematics, pharmacometrics, systems pharmacology, engineering, pharmaceutical sciences, computer sciences, or related disciplines.
• Knowledge of cloud computing platforms such as AWS, Azure, or Google Cloud
• Proficiency or experience working in team settings.

Critical Path Institute is an equal opportunity employer. Visit our website at www.c-path.org

The above statements describe the general nature and level of work only. They are not an exhaustive list of all required responsibilities, duties, and skills. Other duties may be added, or this description amended at any time.

COVID-19

All C-Path employees must vaccinate to safeguard the health of our employees and their families 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.