Jobs
>
Tucson

    Senior Clinical Outcome Assessment Scientist - Tucson, United States - Critical Path Institute (C-Path)

    Critical Path Institute (C-Path)
    Critical Path Institute (C-Path) Tucson, United States

    2 weeks ago

    Default job background
    Description

    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-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.
  • Critical Path Institute (C-Path)

    Senior Clinical Outcome Assessment Scientist

    1 week ago

    Critical Path Institute (C-Path) Tucson, United States

    Job Description · Job DescriptionPlease 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 p ...

  • Critical Path Institute (C-Path)

    Senior Clinical Outcome Assessment Scientist

    1 week ago

    Critical Path Institute (C-Path) Tucson, United States

    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 proces ...

  • Accelerate Diagnostics Inc

    Scientist

    2 weeks ago

    Accelerate Diagnostics Inc Tucson, United States

    **Position Summary** · **Roles and Responsibilities** · - Represent Design Transfer on new product core teams. · - Participate in risk analyses (e.g. dFMEAs and pFMEAs). · - Prepare and participate in data reviews. · - Work cross-functionally (assay development, engineering, soft ...

  • Critical Path Institute (C-Path)

    Associate Director, Scientific

    1 week ago

    Critical Path Institute (C-Path) Tucson, United States

    **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 yea ...

  • University of Arizona

    Research Professional I

    1 week ago

    University of Arizona Tucson, United States

    **Posting Number** · - req19344**Department** · - James C Wyant Coll Optical Sci**Department Website Link**Location** · - Main Campus**Address** · - Tucson, AZ USA**Position Highlights** · - Under general direction, the Research Professional I evaluates, selects, and applies tech ...

  • Terracon Consultants, Inc.

    Staff Scientist

    2 weeks ago

    Terracon Consultants, Inc. Tucson, United States

    Conduct environmental site investigations, assessments and surveys to sample, measure and analyze air, water, material, and soil. Identify, evaluate and recommend risk and remediation strategies/designs to ensure compliance with federal, state and lo Scientist, Staff, Technology, ...

  • University of Arizona

    Co-Director, MD/PhD Dual Degree Program

    1 week ago

    University of Arizona Tucson, United States

    Co-Director, MD/PhD Dual Degree Program (T/TE) (UPDATED) · Posting Number · req19243 · Department · Medicine Administration · Department Website Link · Medical Sub-Speciality · Location · University of Arizona Health Sciences · Address · 1501 N. Campbell Avenue, Tucson ...

  • University of Arizona

    Postdoctoral Research Associate

    3 weeks ago

    University of Arizona Tucson, United States

    Duties and Responsibilities: · The candidate will conduct quality assessment and control of rainforest environmental data and process data into usable ecosystem products such as net ecosystem productivity. The candidate will develop their own research direction based on discussio ...

  • Sion Power Corporation

    Sr. Cell Materials Engineer

    4 weeks ago

    Sion Power Corporation Tucson, United States

    Sion Power Corporation, located in Tucson, AZ, is the leading developer of high-energy rechargeable, lithium metal battery technology with more than 20 years in research and development. Years of research and development has yielded the Licerion lithium metal technology which is ...

  • Montgomery & Associates

    Hydrogeologist (Early Career)

    1 week ago

    Montgomery & Associates Tucson, United States

    Job Description · Montgomery & Associates, Inc. (M&A) is seeking a full-time early-career hydrogeologist to join our Tucson office. The position primarily includes processing and analyzing data, supporting groundwater modeling activities, and preparing technical reports in suppor ...

  • BEPC Incorporated

    Algorithm Engineer

    3 weeks ago

    BEPC Incorporated Tucson, United States

    BEPC has an open position for Pathology Research & Early Development - Algorithm Engineer / Data Scientist in Tucson, AZ · Contract W2 Period: 18-month contract with possibilities for extensions. · Pay & Benefits: $46-$54/hr. + Medical, Dental, Vision and Life Insurance · Hybr ...

  • Dawar Consulting

    Data Scientist/Algorithm Engineer

    2 weeks ago

    Dawar Consulting Tucson, United States

    Job Description · Our client, a leader in life sciences and diagnostics, is looking for a "Data Scientist/Algorithm Engineer". · The selected candidate will work with a highly collaborative team of imaging scientists and software developers to solve image and data analysis prob ...

  • Sion Power Corporation

    Sr. Cell Materials Engineer

    1 week ago

    Sion Power Corporation Tucson, United States

    Sion Power Corporation, located in Tucson, AZ, is the leading developer of high-energy rechargeable, lithium metal battery technology with more than 20 years in research and development. Years of research and development has yielded the Licerion lithium metal technology which is ...

  • Tranzeal

    Data Scientist

    4 weeks ago

    Tranzeal Tucson, United States

    Tranzeal is an industry leading global Business Transformation Service Provider offering specific consulting services as well as pre-packaged, industry specific solutions and services to companies around the world. Our Consulting Services are dedicated to helping our clients maxi ...

  • Dice

    Algorithm Engineer

    2 weeks ago

    Dice Tucson, United States

    Dice is the leading career destination for tech experts at every stage of their careers. Our client, Tranzeal, Inc., is seeking the following. Apply via Dice today · Tranzeal is an industry leading global Business Transformation Service Provider offering specific consulting serv ...

  • Montgomery & Associates

    Hydrogeologist (Early Career)

    1 week ago

    Montgomery & Associates South Tucson, United States

    Montgomery & Associates, Inc. (M&A) is seeking a full-time early-career hydrogeologist to join our Tucson office. The position primarily includes processing and analyzing data, supporting groundwater modeling activities, and preparing technical reports in support of a variety of ...

  • SION Power

    Sr. Cell Materials Engineer

    2 weeks ago

    SION Power Tucson, United States

    Sion Power Corporation, the global leader in development of a new generation of high-energy, rechargeable lithium batteries is currently searching for a Sr. Cell Materials Engineer to be based at its facility in Tucson, Arizona. Covering two decades of research and development, S ...

  • SION Power

    Sr. Cell Materials Engineer

    3 weeks ago

    SION Power Tucson, United States

    Sion Power Corporation, the global leader in development of a new generation of high-energy, rechargeable lithium batteries is currently searching for a Sr. Cell Materials Engineer to be based at its facility in Tucson, Arizona. Covering two decades of research and development, S ...

  • SION Power

    Sr. Cell Materials Engineer

    4 weeks ago

    SION Power Tucson, United States

    Sion Power Corporation, located in Tucson, AZ, is the leading developer of high-energy rechargeable, lithium metal battery technology with more than 20 years in research and development. Years of research and development has yielded the Licerion lithium metal technology which is ...

  • Planet Pharma

    Senior Algorithm Engineer

    3 weeks ago

    Planet Pharma Tucson, United States

    Works with a highly collaborative team of imaging scientists and software developers to solve image and data analysis problems in the field of Digital Pathology. Contributes to algorithm development activities for technology assessment, internal project collaborations, and commer ...