What You’ll Do:

• Develop and execute an innovative translational medicine and biomarker strategy working across the Verge pipeline, from early discovery through clinical studies.
• Demonstrate utility/validation of markers in clinical studies, oversee the assay/method development and patient sample acquisition, assess the natural history of the marker in relevant patient samples/populations, and assess inter- and intra-patient variability .
• Serve as a leader and thought partner with preclinical colleagues to ensure alignment on a translatable biomarker strategy for all programs that advance through the pipeline. Help to identify relevant markers of target and biological pathway engagement and also disease-relevant biomarkers. Facilitate implementation of a robust series of assays to demonstrate drug effects by confirming pharmacodynamic responses in animal models and cellular assays. Acquiring and analyze translational data to guide the design of clinical studies.
• Design and oversee the use of biomarkers in clinical studies, writing protocols for incorporation of biomarkers in clinical trials, training trial sites or clinical CROs to ensure protocols are followed, overseeing the analysis of markers in clinical samples, and preparing reports suitable for regulatory documents.
• Serve as a strong external face of Verge, forming key connections with the disease community, clinical KOLs, and other partners necessary for a successful clinical trial.

What We’re Looking For:

• MD/PhD, or PhD with significant early clinical and preclinical biomarker leadership experience 
• At least 8+ years of industry experience, preferably in translational medicine and/or small molecule development
• Significant exposure to relevant regulatory affairs, including IND submission and FDA advisory committee meetings
• Track record of designing and executing successful early clinical biomarker programs 
• Track record of success developing and executing a translational strategy from preclinical through clinical studies
• Experience leading biomarker programs in neuroscience preferred
• Strong communication skills and a track record of crafting relationships with scientific, regulatory, and clinical KOLs
• A passion for improving the lives of patients with neurodegenerative disease using genomics
• Scrappiness, resourcefulness, and desire to roll up your sleeves to get things done against all odds