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Director/Senior Director, Clinical Quality

Braveheart · San Francisco, CA or Remote or Hybrid · Remote

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About Braveheart

Advancing treatments to improve outcomes and quality of life for patients with hypertrophic cardiomyopathy and related heart conditions. Backed by a16z.

About the role

The Director/Senior Director of Clinical Quality will serve as a senior quality leader for Braveheart Bio and will be responsible for clinical quality oversight and for maintaining a state of inspection readiness for our late-stage clinical program in hypertrophic cardiomyopathy (HCM). Found on 1752vc Careers, the job board for startup and VC roles.

What they're looking for

  • Bachelor’s degree in life sciences, nursing, or related discipline, advanced degree preferred
  • At least 10 years of GCP quality experience, including deep experience in GCP oversight, global clinical development, and late stage development
  • Strong knowledge of global GxP regulations (GCP, GLP, GVP, GDP as applicable) and regulatory expectations for late-stage clinical programs
  • Ability to assess risk, solve complex problems, and implement practical, scalable quality solutions
  • Proven success establishing and executing clinical oversight in a small or emerging biotech environment
  • Experience developing quality oversight strategies, overseeing vendors and CROs, and supporting inspection readiness and regulatory interactions
More about this role

Braveheart Bio is a clinical-stage biopharmaceutical company focused on developing therapies for patients with hypertrophic cardiomyopathy (HCM) and other serious cardiovascular diseases. Our lead product candidate, BHB-1893, is a next-generation oral small-molecule cardiac myosin inhibitor (CMI) being developed for the treatment of obstructive HCM (oHCM) and non-obstructive HCM (nHCM). Braveheart’s goal is to improve the treatment options for these patients by enhancing speed of onset, depth of gradient response, systolic safety, reversibility and reducing prescribing complexity.

With a proven leadership team, a strong financial foundation, and a high-value late-stage asset, Braveheart Bio represents an outstanding opportunity for ambitious, mission-driven professionals to make a tangible impact in a high-profile and rapidly evolving therapeutic area.

The Director/Senior Director of Clinical Quality will serve as a senior quality leader for Braveheart Bio and will be responsible for clinical quality oversight and for maintaining a state of inspection readiness for our late-stage clinical program in hypertrophic cardiomyopathy (HCM). Reporting to the Vice President, Quality, this...

Read the full posting on Braveheart's site ↗

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