Clinical Scientist, Neuroimaging
Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to the genetics and biology of neurodegeneration and the principles of translational medicine.
In anticipation of the Company’s growth plans, Denali Therapeutics is seeking a Clinical Scientist with clinical imaging experience including the design, supervision, monitoring and analysis of imaging outcomes in clinical studies. Ability to contribute to Clinical Development Plans, biomarker development and implementation, novel endpoints or trial designs, and to work across neurological disorders and different phases of development are desired.
Typical activities may include but will not necessarily be limited to:
- With the clinical leader, writing clinical development concepts and plans for molecules at all stages of development
- Research, development and implementation of imaging biomarker outcomes as appropriate for clinical development plan
- Establish and develop neuroimaging-related hypothesis testing, analysis projects and/or collaborations in neurodegenerative diseases and/or pediatric lysosomal storage disorders
- Strategic advice for neuroimaging related patient phenotyping and selection criteria
- Strategic and technical advice for neuroimaging related acquisition, processing, analysis plan and regulatory endpoint strategy
- Contribute to vendor selection and management including specialized vendors involved in critical study endpoints (e.g. neuroimaging, COAs)
- Advise, monitor and supervise vendors or other external parties regarding clinical aspects of imaging outcomes outside of neuroimaging
- Ability to work in a team setting to contribute imaging data to overall development goals for novel therapeutics
- Writing initial and or later drafts of protocol synopses, protocols and protocol amendments
- Writing/reviewing informed consent forms and reviewing/adjudicating site-specific ICF requests
- Partnering with Clinical Operations on site selection, start-up and communication and study execution
- Serving as a member of the clinical sub team on development projects
- Assisting with clinical study reports and associated publications
- Creating clinical study- or program-related slide decks for internal and external use
- Training of colleagues, CRO and study site staff on the therapeutic area, molecule and protocols as appropriate
- Contributing to or performing therapeutic area/indication research and competitor analysis
- Building and maintaining opinion leader/investigator networks in neuroimaging; attending and contributing to scientific conferences
- Support Health Authority (HA) interactions, updates and contributing to regulatory submissions (e.g. investigator brochures, INDs, etc) and assisting in responses to HA requests, inspection observations and internal audits
Additional study level activities include presentation of study results to internal and external committees or advisory boards, presentation of data at international scientific meetings and publication of study results in peer-reviewed journals. In addition to study level activities, the Clinical Scientist, Neuroimaging will participate in program level activities including authoring/reviewing safety and efficacy summaries, clinical overviews, investigator brochures, risk management plans, periodic safety updates and clinical sections of product labels.
QUALIFICATIONS & EXPERIENCE:
- PhD and/or MD degree and strong knowledge of clinical neuroimaging gained through formal training or previous clinical research experience are required
- Experience in structural or molecular neuroimaging studies including design, execution, data analysis and interpretation
- Experience in clinical trials or clinical studies (e.g. natural history studies) preferred
- Experience in neuroimaging and clinical outcomes pertaining to neurodegenerative disease or pediatric neurological disorders preferred but not required
- Skilled in protocol design, clinical data interpretation, and monitoring of imaging processes and data acquisition by external partners
- Knowledge of Good Clinical Practice
- Excellent written and oral communication
- Capacity to adapt to a fast-paced and changing environment
- Fluency in English is required.
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 Range: $157,000 to $182,667. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers
*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.