What are the responsibilities and job description for the Clinical Outcomes Scientist position at Denali Therapeutics Inc?
Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients.
We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.
Key Accountabilities/Core Job Responsibilities:
Provide technical neurocognitive outcomes expertise to support selection, modification or development of key neuropsychological endpoints across programs
Generate and/or assess evidence on psychometric properties, clinical meaningfulness, and regulatory gaps for neuropsychological clinical outcomes
Contribute to the development and execution of operational plans for endpoints including: translation, cultural adaptation, rater training, protocol implementation, and monitoring of trial data
Assist with quality monitoring of key neuropsychological endpoints, including data review for early and late stage studies
Key contributor to design, authoring, and review of clinical study protocols and study process manuals
Collaborate and work cross functionally across business units and project teams, e.g., Clinical, Operations, Data Management, Biometrics, Regulatory, and Medical Affairs
Effectively manage vendors to deliver results according to timelines and business objectives
Effectively collaborate with clinical trial sites and site raters to ensure proper delivery and collection of trial outcome assessments.
Qualifications/Skills:
PhD in neuropsychology (or related discipline) strongly preferred; PhD or advanced degree (MS, MD, PharmD, PsyD) in a related scientific discipline required.
Active professional licensure in psychology (or equivalent) strongly preferred.
2 years experience conducting (neuro)psychological assessments preferred. Post-doctoral experience will be considered.
2 years experience performing clinical outcomes research in a life sciences company, research organization, academic institution, or governmental agency
Experience in one or more disciplines within outcomes research in pediatric, neurodegenerative and/or rare disease therapeutic areas
Strong knowledge of the development, psychometrics, administration, and analysis of neuropsychological and behavioral assessments.
Familiarity with the role and importance of outcomes research in a multi-disciplinary drug development and commercialization environment and process involving multiple stakeholders
Experience training or teaching psychological assessments is preferred.
Excellent qualitative and quantitative skills in study design, analysis and interpretation of data from research
This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.
Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.
Salary : $129,000 - $157,000