Senior Clinical Outcome Assessment Scientist

Found in: Appcast Linkedin GBL C2 - 2 weeks ago

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

About Critical Path Institute (C-Path):

Critical Path Institute (C-Path) is a multi-disciplinary global nonprofit organization 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 fifteen years, we have partnered with academic, regulatory agencies and industry 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.


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


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.

  • Senior Clinical Outcome Assessment Scientist

    2 days ago

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

    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...

  • Senior Clinical Outcome Assessment Scientist

    Found in: Talent US C2 - 2 weeks ago

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

    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...

  • Senior Clinical Outcome Assessment Scientist

    2 weeks ago

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

    Job DescriptionJob 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 partnerships and innovative processes that improve human health by reducing the time,...

  • Program Assessment Professional

    2 days ago

    Tucson, United States University of Arizona Full time

    Responsible for the collaborative development and execution of the evaluation of CAST academic programs and the related data collection, management, and reporting protocols.Work with relevant faculty and staff on program assessment methods to improve, modify or innovate teaching and learning outcomes. Collaborate with faculty and staff to identify evaluation...

  • Staff Scientist

    2 days ago

    Tucson, United States Terracon Consultants, Inc. Full time

    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, Construction, Assessment, Environmental

  • Senior Research Scientist

    2 days ago

    Tucson, United States University of Arizona Full time

    Research Development, Design and Execution: Develops, plans, designs, and conducts research.Reviews progress and evaluates results forwarding the generation of new knowledge and understanding surrounding the impact of biological and mechanical activation of whole blood and blood platelets related to thrombotic events specifically targeting the bleeding and...

  • CDx Clinical Lab Scientist I

    2 days ago

    Tucson, United States Hoffmann-La Roche Ltd Full time

    Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people's varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...

  • Clinical Informaticist

    1 week ago

    Tucson, United States Tucson Medical Center Full time

    **SUMMARY**: Assesses, plans, implements and evaluates clinical information system support needs for patient care operations according to policies, procedures, protocols, and standards. The clinical informaticist is responsible for clinical system assessment, workflow charting, process analysis, and identifying and implementing clinical information system...

  • Clinical Laboratory Assistant

    Found in: Lensa US P 2 C2 - 2 weeks ago

    Tucson, United States Revel IT Full time

    Our Tucson, AZ client has a contract opening for a Clinical Laboratory Assistant.Shift: 1st ShiftSchedule: Monday through Friday*JOB SUMMARY: This job is located in the CAP/CLIA Laboratory. Utilizes good documentation practices and follows laboratory safety policies. Maintains ethical standards in the performance of testing and in interactions with patients,...

  • Algorithm Engineer

    1 day ago

    Tucson, United States R&D Partners Full time

    Ready to take your engineering career to new heights? Join our team and explore the exciting job opportunities available in the dynamic field of Engineering. As an engineer, you'll have the opportunity to innovate, create cutting-edge solutions, and have a direct impact on society. With endless opportunities for growth, job satisfaction, and the chance to...

  • Clinical Informaticist

    2 days ago

    Tucson, United States Tucson Medical Center Full time

    Clinical Informaticist Job CategoryInformation Technology ScheduleFull time Shift1 - Day Shift SUMMARY: Assesses, plans, implements and evaluates clinical information system support needs for patient care operations according to policies, procedures, protocols, and standards. The clinical informaticist is responsible for clinical system assessment,...

  • Clinical Laboratory Assistant I

    2 days ago

    Tucson, United States Dawar Consulting, Inc. Full time

    Job DescriptionOur client, a world leader in Pharmaceuticals & In vitro diagnostics (IVD), is looking for a "Clinical Laboratory Assistant".Job Type: Long-term Contract (Possibility Of Further Extension)Location: Tucson, AZ (Oro Valley)Note: A 3-month contract role designed for college students on summer breakCompany Benefits include:• Healthcare (Medical,...

  • Clinical Lab Assistant

    4 days ago

    Tucson, United States SGA Full time

    Job DescriptionJob DescriptionSoftware Guidance & Assistance, Inc., (SGA), is searching for an Clinical Lab Assistant for a Contract assignment with one of our premier Pharmaceutical Services clients in Tucson, AZ. KEY SKILLS:- 2 years of Clinical Laboratory experience- Experience in handle single and multichannel pipettes- Understanding of good...

  • Data Scientist/Algorithm Engineer

    7 hours ago

    Tucson, United States Dawar Consulting Full time

    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 problems in the field of Digital Pathology. S/he will contribute to algorithm development...

  • Data Scientist/Algorithm Engineer

    1 week ago

    Tucson, United States Dawar Consulting, Inc. Full time

    Job DescriptionJob DescriptionOur 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 problems in the field of Digital Pathology. S/he will contribute to...

  • Data Scientist/Algorithm Engineer

    3 days ago

    Tucson, United States Dawar Consulting, Inc. Full time

    Job DescriptionJob DescriptionOur 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 problems in the field of Digital Pathology. S/he will contribute to...

  • Clinical Manager Home Health Full Time

    7 days ago

    Tucson, United States CenterWell Full time

    **Become a part of our caring community and help us put health first**: - Develops, plans, implements, analyzes, and organizes clinical operations for a specific location managed. - Conducts/delegates the assessment and reassessment of patients, including updating of care plans and interpreting patient needs, while adhering to Company, physician, and/or...

  • Senior Instrumentation Engineer

    2 weeks ago

    Tucson, United States CareerBuilder Full time

    Senior Instrumentation Engineer - ( 177165 ) Description About Us At HDR, we specialize in engineering, architecture, environmental and construction services. While we are most well-known for adding beauty and structure to communities through high-performance buildings and smart infrastructure, we provide much more than that. We create an unshakable...

  • Clinical Applications Analyst

    1 week ago

    Tucson, United States Tucson Medical Center Full time

    **SUMMARY**: **ESSENTIAL FUNCTIONS**: **Attends and participates in team, project and department meetings to increase awareness and information flow.**: **Meets with customers frequently and provides frequent written status updates to customers, team members, and department management using approved modes of communication.**: **Identifies solutions to...

  • Clinical Applications Analyst

    2 days ago

    Tucson, United States Tucson Medical Center Full time

    Clinical Applications Analyst Job CategoryInformation Technology ScheduleFull time Shift1 - Day Shift SUMMARY: Provides support to clinical units in the use of the clinical information systems and other assigned applications. Assists in the development of system scope and objectives through research and fact-finding combined with an understanding of...