Job type full-time
Benefits pulled from the full job description
401(k) dental insurance disability insurance flexible spending account food provided health insurance show 4 more benefits
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Full job description
Verge genomics is a next-generation biopharmaceutical start-up using human genomics to accelerate development of life-saving treatments for neurodegenerative diseasesOur platform uses patient tissue profiling, human genetics, and machine learning to identify new therapeutic gene targets, predict effective drugs, and stratify patient subpopulations for increased clinical successVerge`s approach offers a breakthrough opportunity to identify drugs that dramatically improve patient outcomes and fundamentally lower the cost curve of pharmaceutical development.
As the head of translational medicine, you will be responsible for developing verge’s early clinical biomarker strategy and oversee operationalization of biomarker studies in our phase 1 trials, including the establishment of clinical and analytical lab infrastructure and key relationshipsYou will also drive the selection of clinical biomarkers for target engagement, patient selection, and signs of efficacy leveraging the unique insights gained from verge’s genomics platformThe head of translational medicine will also interface with the preclinical discovery teams to help drive efforts related to novel biomarker discovery using verge`s industry-leading multi dimensional discovery platform and ensure a comprehensive biomarker strategy is implemented for all preclinical discovery programs.
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 pipelineHelp to identify relevant markers of target and biological pathway engagement and also disease-relevant biomarkersFacilitate implementation of a robust series of assays to demonstrate drug effects by confirming pharmacodynamic responses in animal models and cellular assaysAcquiring 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
Perks & benefits
Medical, dental, and vision insurance
Short- and long-term disability insurance
Free lunch and snacks onsite
Free on-site gym access (currently restricted due to covid)
Help us revolutionize the way drugs are discovered & developed: currently, it takes on average 12 years and $2.6 billion to get a single drug to market, with the drug discovery and development process costing $1.4 billionVerge genomics has raised $51 million in venture capital to change this broken model by fueling the drug discovery pipeline with machine learning.
Posted 30+ days ago