Braveheart Bio

Braveheart Bio

Director, Quality (Clinical)

San Francisco, CA or Remote or Hybrid · Director

Sponsorship not specified$195k-$230kDetected 33 days ago
GCPComplianceClinical TrialsPatient CareGMPLeadershipCommunicationCollaborationGxP

About the role

  • This is a hands-on, strategic, and foundational role for a lean, fast-moving biotech entering late-stage development.

Responsibilities

  • Lead clinical quality strategy aligned with global regulatory requirements, risk-based quality principles, and business priorities, while supporting non-clinical quality activities as needed
  • Establish fit-for-purpose quality practices that support late-stage development, clinical data integrity, inspection readiness, and regulatory submissions.
  • Serve as a trusted quality partner to clinical and nonclinical teams, proactively identifying, assessing, and mitigating risk.
  • Drive continuous improvement to strengthen quality culture, streamline execution, and improve compliance effectiveness
  • Develop and execute clinical quality oversight plans, including study-level, CRO, vendor, site, system, and data-focused oversight activities
  • Lead quality oversight of clinical trials using a risk-based model
  • Provide quality oversight of clinical trial conduct, protocol compliance, informed consent, investigator/site compliance, safety reporting interfaces, TMF quality, essential documents, monitoring quality, and issue escalation
  • Support computerized system validation for clinical and nonclinical systems, including oversight of validation activities and review of validation documentation

Requirements

  • Strong knowledge of global GxP regulations (GCP, GLP, GMP, GVP, GDP as applicable) and regulatory expectations for late-stage clinical programs
  • Demonstrated ability to evaluate clinical data integrity, endpoint reliability, documentation quality, monitoring effectiveness, vendor data flows, and inspection readiness of clinical trial data.

Nice to have

  • advanced degree preferred

Skills

  • Bachelor's degree in life sciences, health sciences or related discipline; advanced degree preferred
  • At least 10 years of GxP quality experience, including deep experience in GCP oversight and global clinical development
  • Proven success establishing and executing clinical and nonclinical oversight in a small or emerging biotech environment
  • Demonstrated experience with computerized system validation for clinical and nonclinical systems in a regulated environment
  • Strong written and verbal communication skills with a collaborative, team-oriented approach
  • Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity
  • Flexible, proactive, and hands-on mindset with a roll-up-your-sleeves, can-do attitude
  • Preferred experience &
  • Experience in rare disease, cardiovascular, or specialty disease clinical development
  • Experience supporting preparation for major regulatory submissions (NDA/BLA/MAA)
  • Experience with nonclinical quality oversight, GLP compliance, or nonclinical vendor oversight
  • Working knowledge of GDPR and clinical trial data privacy requirements

Compensation

  • Braveheart participates in the federal E ‑ Verify program to confirm employment authorization for all new hires.
  • To learn more about E-Verify please review this poster.
  • $195,000 - $230,000

Company info

  • 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 role:
  • The Director of Quality will serve as a senior quality leader for Braveheart Bio and will be responsible for clinical quality oversight, clinical data integrity, GCP inspection readiness, and support of nonclinical quality activities as needed for our late-stage clinical program in hypertrophic cardiomyopathy (HCM). Reporting to the Vice President, Quality, this individual will execute the clinical oversight framework to support global Phase 3 execution, guide clinical development teams, and prepare the organization for future regulatory submissions and commercialization activities. This is a high-exposure role requiring a senior quality leader who can independently evaluate complex clinical quality issues, identify material risks, and make well-supported recommendations that preserve data integrity, subject protection, regulatory compliance, and inspection readiness. This leader will partner closely with Clinical Development, Regulatory, Biometrics, PV, Data Management, Medical, Legal and external CRO and vendor partners to ensure effective, inspection-ready clinical quality oversight across all programs. The Director may also build and lead a small quality team as Braveheart grows. This is a hands-on, strategic, and foundational role for a lean, fast-moving biotech entering late-stage development.
  • 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.
  • The Director of Quality will serve as a senior quality leader for Braveheart Bio and will be responsible for clinical quality oversight, clinical data integrity, GCP inspection readiness, and support of nonclinical quality activities as needed for our late-stage clinical program in hypertrophic cardiomyopathy (HCM).
  • Reporting to the Vice President, Quality, this individual will execute the clinical oversight framework to support global Phase 3 execution, guide clinical development teams, and prepare the organization for future regulatory submissions and commercialization activities.
  • This is a high-exposure role requiring a senior quality leader who can independently evaluate complex clinical quality issues, identify material risks, and make well-supported recommendations that preserve data integrity, subject protection, regulatory compliance, and inspection readiness.
  • This leader will partner closely with Clinical Development, Regulatory, Biometrics, PV, Data Management, Medical, Legal and external CRO and vendor partners to ensure effective, inspection-ready clinical quality oversight across all programs.
  • The Director may also build and lead a small quality team as Braveheart grows.

Equal opportunity

  • We are an equal opportunity employer.
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