Translational Science Lead - CNS
- Employer
- Spark Therapeutics
- Location
- Philadelphia, Pennsylvania. Hybrid and remote options available for select opportunities.
- Salary
- Salary not provided
- Closing date
- Jul 12, 2022
View more
- Discipline
- Life Sciences, Biotechnology
- Organization Type
- All Industry, Pharma
Job Details
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Manage the translational strategy and implementation for CNS-directed assets.
Develop and implement the translation biomarker strategy for the asset, participating in the Compound Development and Non-Clinical Study Teams. This will include achieving consensus on the key scientific questions, the assays and samples needed to address them, and the analytic approach to the resulting data in concert with Research Therapeutic Area leads, Clinical Development leads and biomarker leads in Biometrics.
Work with the preclinical research teams to choose suitable and informative model systems (in vitro or in vivo) to answer key questions and to ensure best translatability of results
Work with preclinical research teams to acquire key data in human patients/samples which can validate a particular target or approach
Coordinate the analysis and sharing of translational results with Non-Clinical Study Teams, Asset Teams, and to wider audiences internally and externally.
Interact with internal and external experts and CROs to ensure that Spark can bring state-of-the-art technology and analysis to our translational plans.
Contribute to the biomarker sections for clinical protocols, investigator brochures, clinical study reports, licensing applications, and other regulatory documents.
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PhD with 12+ years of experience, or MD with 8+ years of experience, in neuroscience, molecular biology, immunology, or related field and 5+ years of relevant experience in CNS translational research and/or clinical trial experience, preferably in an industry setting. Statistical and computational biology experience are a major plus.
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Familiarity with neurosurgical procedures associated with administration of CNS-directed gene therapies is highly desirable
Experience with clinical immunogenicity of therapeutics and / or gene therapy is a plus
Familiarity with techniques frequently used in Spark translational research, such as antibody-based protein detection and quantitation, imaging (eg, MRI, PET) and functional testing.
Excellent written and oral presentation skills.
Experience working with matrixed teams and project management preferred.
- Decision-making will be necessary to identify and prioritize scientific questions/hypotheses and the associated assays and analysis plans, balancing them with operational considerations within clinical trials
Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.
Nearest Major Market: Philadelphia
Join the Spark Team
We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.
We don't follow footsteps. We create the path.
Company
At Spark Therapeutics, a fully integrated, commercial company committed to discovering, developing and delivering gene therapies, we challenge the inevitability of genetic diseases, including blindness, hemophilia, lysosomal storage disorders and neurodegenerative diseases.
Founded in March 2013 as a result of the technology and know-how accumulated over two decades at Children’s Hospital of Philadelphia (CHOP), our investigational therapies have the potential to provide long-lasting effects, dramatically and positively changing the lives of patients with conditions where no, or only palliative, therapies exist. Greater understanding of the human genome and genetic abnormalities have allowed our scientists to tailor investigational therapies to patients suffering from very specific genetic diseases. This approach holds great promise in developing effective treatments to a host of inherited diseases. Our initial focus is on treating orphan diseases.
Headquartered in dynamic Philadelphia, we are a diverse, experienced team united in our goal to break down barriers for people and families affected by genetic diseases. As our name suggests, our investigational, one-time therapies are designed to spark healthy biology, and deliver potentially life-altering transformation for people and families affected by genetic disease. Spark is a member of the Roche Group.
- Website
- http://sparktx.com/
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