
25 Nov Sr Scientist/Principal Scientist, Clinical Imaging, Biomarkers
Sr Scientist/Principal Scientist, Clinical Imaging, Biomarkers
Research & Development · Cambridge, MA · Full-time
Job Description
About This Role
The Biomarkers group is seeking a neuroimaging scientist to lead application of imaging in Biogen clinical trials to aid one or more of the following: a) selection of the right patient for the right therapy, b) demonstration of proof-of-biology, c) demonstration of disease-modifying effect of investigational therapies, and d) analysis, interpretation, and communication of data to advance Neuroscience drug development programs.
The Senior Scientist/Principal Scientist will advise drug development teams on the application of imaging biomarkers and oversee its deployment in Biogen clinical trials in neurodegenerative or neurovascular disease areas. You will work closely with multidisciplinary teams and will be viewed and sought out as an imaging expert from functions across Biogen. Therefore, you will gain a unique opportunity to partner with an interdisciplinary team to drive application of clinical imaging and other biomarkers to active drug development programs.
Who you are:
- You will possess excellent interpersonal and communications skills, while also holding scientific proficiency evidenced by a strong publication record and experience presenting in academic, congress or industry settings.
- You will interact effectively, deliver clear, concise communication of technically complex material that is easily understood, persuasive and actionable to cross-functional teams, internal governance bodies and external stakeholders including regulatory agencies.
What You’ll Do:
- Work with drug development teams to drive biomarker strategy development, selection and deployment of fit-for-purpose biomarkers a) for selection of optimal patient population for clinical trials, b) demonstrate target engagement and c) demonstrate proof-of-biology and/or disease-modifying effect of investigational therapies.
- Serve as subject matter expert on the application of neuroimaging to drug development teams and contribute to clinical development plans
- Support the implementation and oversight of imaging in clinical trials by providing input into site selection, assessment and selection of imaging core lab partners, trial-specific agreements, trial-specific imaging documents (procedure manuals, charters, image analysis plan). Manages relationships and coordinate activities with imaging service providers.
- Ensure that data collection, analyses, data transfers, and reporting are performed in accordance with the study protocol and in compliance with regulatory requirements.
- Contribute to regulatory engagements and biomarker-related sections in relevant dossiers such as clinical protocols, ICFs, INDs, IBs, clinical study reports, etc.
- Develop and grows internal and external partnerships with scientific leaders, investigators and vendor partners
- Effectively communicate ideas, methodology, and findings to both technical and non-technical audiences
- Represent Biogen and lead advances in the field through participation in conferences, consortia-led events, and publications
Qualifications
Required Skills
- PhD in neuroscience, neuropsychology, biomedical engineering, or related field with 5+ years relevant post-doctoral, industry experience (biotech/pharma/CRO setting) in neuroimaging applied to clinical trials. The level will be commensurate with experience
- Hands-on research experience in disease areas such as Alzheimer’s disease, neurovascular or other neurodegenerative disorders with expertise in one or more of molecular, functional, structural or neurovascular imaging
- Scientific and operational expertise in applying neuroimaging (PET, MRI, CT) to clinical trials with demonstrated experience in clinical trial imaging either in an academic imaging center, CRO, or biotech/pharmaceutical company.
- Strong understanding of clinical imaging technologies such as PET, CT, and MRI, knowledgeable of the strengths, limitations of these tools and considerations related to the implementation in global clinical trials
- Resourceful and self-motivated with a track record of productive research
- Strong and effective communication, inter-personal relationship skills with ability to work in large and diverse teams
Preferred Skills
- Experience in leading and/or supporting biomarker strategy and deployment for Neuroscience drug development programs in pharma/biotech setting
Additional Information
At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. Biogen has the leading portfolio of medicines to treat multiple sclerosis, spinal muscular atrophy, and has recently introduced the first anti-amyloid treatment for Alzheimer’s disease in the US. Biogen is deeply committed to advancing neuroscience research programs in Alzheimer’s disease and dementia, multiple sclerosis and neuroimmunology, movement disorders, neuromuscular disorders, pain, neuropsychiatry and neurovascular disorders.
All your information will be kept confidential according to EEO guidelines.
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