Clinical Outcome Assessment Scientist

Employer
Critical Path Institute
Location
Tucson, AZ
Closing date
Dec 4, 2022

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Sector
Science
Organization Type
Corporate
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!

POSITION OVERVIEW

The Clinical Outcome Assessment (COA) Scientist is responsible for assisting the COA Program Vice President, PRO Consortium Executive Director, and other COA Program scientific staff in working with consortia/programs within Critical Path Institute (C-Path) to advance and document the development and/or evaluation of PRO measures and other COAs for use in drug development where COA-based endpoints are used to support the evaluation of clinical benefit.

SUPERVISORY RESPONSIBILITIES

None

CORE DUTIES/RESPONSIBILILITIES
  • Serve as scientific lead for select therapeutic area working groups within the PRO Consortium
  • Provide scientific input/expertise to selected project teams during all stages of the COA development, evaluation, and/or regulatory review and endorsement processes (e.g., qualification)
  • Assist with selecting, managing, and/or collaboratively working with outside vendors engaged to help accomplish specific project goals
  • Lead or participate in the generation and execution of analysis plans for the quantitative evaluation of COAs
  • Participate in the preparation of grant applications for targeted funding opportunities
  • Participate in the development and presentation of educational/training activities within C-Path and beyond
  • Lead and/or participate in writing teams focused on disseminating scientific achievements/advances in peer-reviewed journals and other scientific venues
  • Review and provide critical/constructive feedback on vendor deliverables
  • Lead or participate in the preparation of formal documents for submission to regulatory agencies
  • Represent C-Path at national and international scientific and regulatory meetings
  • Other duties and responsibilities as assigned

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
  • Excellent oral, written, and virtual communication skills
  • Able to lead the writing of manuscripts for publication in peer-reviewed journals from inception to acceptance (If not on resume/CV, please provide a list of your publications in your cover letter.)
  • Knowledge of FDA and EMA regulations, requirements, and expectations regarding clinical trial efficacy endpoints, particularly COA-based endpoints
  • Thorough understanding and experience in the development and evaluation of COAs (e.g., PRO measures, observer-reported outcome [ObsRO] measures, clinician-reported outcome [ClinRO] measures, performance outcome [PerfO] measures)
  • Proficiency in R and J Metrik is preferred
  • Strategic planning and leadership skills
  • Effective management, interpersonal, negotiation, time management, and problem-solving skills
  • Able to productively engage in complex, multi-stakeholder collaborations and research teams
  • Able to meet target deadlines and manage time effectively
  • Able to identify opportunities for improvement, make constructive suggestions for change, and operationalize those within the team
  • Demonstrates sound business judgment when making decisions and adheres to external and internal policies and regulations
  • Strong critical thinking and analytical skills (Please provide specific examples in your cover letter.)
  • Able to successfully anticipate issues or challenges and proactively address without being specifically directed
  • Sound judgment when working with critical or confidential information
  • Proficient in the use of Microsoft Office Suite: Word, Excel, PowerPoint, Outlook

REQUIRED EDUCATION AND EXPERIENCE
  • A PhD (or equivalent doctoral degree) is preferred in Health Outcomes, Psychology, Public Health, Psychometrics, Epidemiology, Biostatistics, or related scientific discipline
  • A minimum of five years' experience in health outcomes research and, specifically, in the qualitative and quantitative components of ensuring valid and reliable assessment of clinical benefit in drug treatment trials
  • A firm grasp of the pharmaceutical/biotechnology industry, FDA, EMA, and the healthcare environment
  • Broad scientific, clinical, technical, and regulatory understanding of the functions involved in the development of pharmaceutical products

COVID-19

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 be vaccinated 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.

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 ay be added, or this description amended at any time.

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