Please ensure that the knowledge, skills, and abilities are included on your resume/CV, if not, address in your cover letter.

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

The Senior Clinical Outcome Assessment (COA) Scientist works with the Vice President of the COA Program to collaborate with consortia and programs across Critical Path Institute (C-Path) to advance the use of COAs in drug development for supporting the evaluation of clinical benefit.

SUPERVISORY RESPONSIBILITIES

The position currently does not supervise personnel but may in the future.

CORE DUTIES/RESPONSIBILITIES

• Provide scientific input/expertise to project teams during all stages of COA development, evaluation, and/or regulatory review and endorsement processes (e.g., qualification).
• Advise project teams on regulatory pathways and regulatory guidances or precedents that should inform project activities and decisions.
• Assist with selecting, managing, and/or collaborating with outside vendors engaged to help accomplish specific project goals.
• Lead or participate in the generation and development of materials associated with the qualitative and quantitative evaluation of COAs.
• Lead or participate in the preparation of grant applications and serve as principal investigator 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
• Experience in navigating 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)
• 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)
• Strategic planning and effective leadership skills
• Excellent problem-solving skills and time management skills to ensure project deadlines are met.
• Excellent interpersonal, management, and negotiation skills
• Demonstrated ability to productively engage in complex, multi-stakeholder collaborations and research teams.
• Demonstrated ability to identify opportunities for improvement, make constructive suggestions for change, and operationalize those within the team.
• Exercise sound business judgment when making decisions and adhere to external and internal policies and regulations.
• Strong critical thinking and analytical skills (Please provide specific examples in your cover letter.)
• Successfully anticipate issues or challenges and proactively address.
• Exercise sound judgment when working with critical or confidential information.
• Proficient in the use of Microsoft Office Suite: Word, Excel, PowerPoint, and 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 7 to 10 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.

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.