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Head of Translational Medicine

South San Francisco, CA 94080

Posted: 11/01/2022 Employment Type: Direct Hire/Perm Job Number: 329348-1 Country: United States Is job remote?: No

Job Description

Our client is a well funded start-up using human genomics to accelerate development of treatments for neurodegenerative diseases. The approach our client is taking is a true breakthrough opportunity using human genetics and machine learning to identify drugs that can drastically improve patient outcomes AND lower the drug development cost.

Title: Head of Translational Medicine
Responsible for developing early clinical strategy and overseeing the execution of Phase 1 trials, including the establishment of clinical infrastructure and key relationships. You will also drive the selection of clinical biomarkers for target engagement, patient selection, and signs of efficacy leveraging the unique insights gained from the proprietary genomics platform.  What You' ll Do:
  • Develop and execute an innovative translational medicine and biomarker strategy
  • 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 
  • Oversee pre-clinical studies demonstrating a drug effect on the marker by confirming response of the marker to drugs in animal models and cellular assays, and acquiring translational data required 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
  • Lead planning and preparation for Phase I, and Phase IIa/b clinical trials
  • Oversees the execution of Phase 1 trials, including selection of the clinical trial sites, analysis of the trial data, and preparation of regulatory documents 
  • Serve as a strong external face of the company to form key connections with the disease community, clinical KOLs, and other partners necessary for a successful clinical trial
Perks & Benefits
  • Medical, dental, and vision insurance
  • Healthcare FSA
  • Short- and long-term disability insurance
  • Life insurance
  • 401k 
  • Company equity
  • Unlimited PTO
  • Free lunch and snacks onsite
  • Free on-site gym access (currently restricted due to COVID)

 
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