Director, Quality (Clinical)

About the 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 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.

Responsibilities

• Quality Strategy & Leadership
• 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.
• Provide clear, well-supported quality recommendations to cross-functional teams and senior leadership, including appropriate escalation of material risks and proposed paths to resolution.
• Drive continuous improvement to strengthen quality culture, streamline execution, and improve compliance effectiveness
• GCP/GLP Quality Oversight
• Serve as the company's GCP and GLP subject matter expert
• Provide quality guidance across nonclinical and clinical development activities
• 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
• Assess clinical quality and data integrity risks including adjudication processes, data transfer, and data reconciliation
• Support computerized system validation for clinical and nonclinical systems, including oversight of validation activities and review of validation documentation
• Evaluate clinical computerized systems and data flows for data integrity risk
• Oversight & Compliance
• Ensure timely and effective resolution of quality issues
• Maintain inspection readiness across clinical and nonclinical activities, documentation, systems, vendors, and teams, in coordination with broader inspection readiness activities
• Data Integrity & Clinical Data Quality
• Review and interpret clinical quality signals, including protocol deviations, monitoring findings, audit findings, data discrepancies, CAPAs, TMF gaps, safety reporting, and vendor performance trends
• Partner with other functions and vendors to identify risk areas and develop mitigation strategies
• Cross-Functional Collaboration
• Work closely with clinical developme

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