What are the responsibilities and job description for the Associate Director, Clinical Biomarkers & Translational Medicine position at Vigil Neuroscience, Inc.?
Vigil Neuroscience is the world's first microglia-focused therapeutics company. Our purpose is clear: to treat rare and common neurodegenerative diseases by restoring the vigilance of the microglia, the sentinel cells of the brain's immune system. We are utilizing the tools of modern neuroscience drug development across multiple therapeutic modalities to rapidly deliver precision-based therapies to improve the lives of patients and their families.
Vigil is seeking a highly collaborative and energetic Biomarker & Translational Medicine Scientist to join our growing Clinical Sciences team. Reporting to the Head of Clinical Biomarker/Translational Medicine, the Associate Director of Clinical Biomarkers & Translational Medicine will help drive the selection, implementation, and interpretation of clinical biomarkers for patient selection, target engagement, proof-of-pharmacology, and early signs of efficacy.
This role will contribute to the identification of appropriate platforms/vendor partners, its implementation and oversight of data generation and quality. They will ensure appropriate data analysis and interpretation to support decision making for clinical-stage programs and collaborate cross functionally to achieve these objectives. This role also involves collaborating with internal teams (e.g. biology, clinical) and external experts to help drive efforts related to novel biomarker discovery and qualification, prioritization of target/disease areas in support of discovery and early clinical programs.
Key Responsibilities:
Required Skills:
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Vigil is seeking a highly collaborative and energetic Biomarker & Translational Medicine Scientist to join our growing Clinical Sciences team. Reporting to the Head of Clinical Biomarker/Translational Medicine, the Associate Director of Clinical Biomarkers & Translational Medicine will help drive the selection, implementation, and interpretation of clinical biomarkers for patient selection, target engagement, proof-of-pharmacology, and early signs of efficacy.
This role will contribute to the identification of appropriate platforms/vendor partners, its implementation and oversight of data generation and quality. They will ensure appropriate data analysis and interpretation to support decision making for clinical-stage programs and collaborate cross functionally to achieve these objectives. This role also involves collaborating with internal teams (e.g. biology, clinical) and external experts to help drive efforts related to novel biomarker discovery and qualification, prioritization of target/disease areas in support of discovery and early clinical programs.
Key Responsibilities:
- Serve as subject matter expert on the application of fit-for-purpose fluid and/or imaging biomarkers to drug development programs, contribute to clinical development plans and associated data generation initiatives.
- Analyze, interpret, and present results from clinical biomarker studies to project teams and senior leadership to inform on design of clinical studies and decision making.
- Manage relationships and coordinate research activities with bioanalytical labs and/or imaging vendors, oversee assay development, sample testing plans and quality of data generation in compliance with study protocol and regulatory guidelines.
- Collaborate with clinical study team in the preparations of clinical study related documents including protocols, informed consent forms, procedure manuals, analysis plans, clinical study report, sections of regulatory documents and other essential documents.
- Foster academic collaborations to discover and characterize fit-for-purpose biomarkers in relevant patient samples; leverage public/proprietary data repositories to conduct analysis of genetics, omics, and clinical data to characterize disease risk/progression to inform on patient population and relevant biomarkers.
- Serve as a thought partner to discovery colleagues to develop translatable biomarker plans for programs that advance through the pipeline.
- Represent Vigil at scientific conferences, consortia-led events, and foster partnerships with the scientific community.
Required Skills:
- Advanced scientific degree (Ph.D., Pharm D., M.S., or similar degree) in neuroscience, neuropsychology, biomedical engineering, bioinformatics, or related field with at least 3 years of relevant post-doctoral and/or industry experience in the application of biomarkers (fluid and/or imaging) to clinical research, preferably in neurodegenerative diseases. The level will be commensurate with experience.
- Scientific and operational expertise in applying fluid biomarkers and/or imaging to clinical trials with demonstrated experience in an academic, CRO, or biotech/pharmaceutical setting.
- Strong quantitative skills with track record of analyzing and interpreting data from translational and experimental medicine type studies; knowledgeable in the principles of clinical research methodology and statistics.
- Experience managing biomarker projects with CROs or academic partners, familiarity with analytical validation of biomarker assays and clinical biomarker sample logistics.
- Ability to work effectively both independently and as part of multidisciplinary drug development teams with strong communication skills.
- Ability to foster credible relationships with scientific community, investigators, and vendor partners.
- Track record of designing and executing translational/early clinical biomarker programs for Neuroscience drug development in pharma/biotech setting.
- Experience with novel fluid biomarker discovery using technologies involving transcriptomics/proteomics or implementing validated immunoassay and molecular assays.
- Understanding of biomarker measures used in neurodegenerative disorders.
- Experience in the analysis of multi-factorial clinical trial datasets, such as human genetics, biomarker, imaging, and clinical data.
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