About us:
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/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 individual will establish and 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 leader will partner closely with Clinical Operations, Regulatory, Biometrics, Pharmacovigilance, and external CRO and vendor partners to ensure best-in-class quality oversight across all programs. The Director/Senior 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.
Key responsibilities:
Quality Strategy & Leadership
Lead clinical quality strategy aligned with global regulatory requirements, risk-based quality principles, and business priorities
Establish fit-for-purpose quality practices that support late-stage development and inspection readiness
Serve as a trusted quality partner to clinical teams, proactively identifying, assessing, and mitigating risk
Drive continuous improvement to strengthen quality culture, streamline execution, and improve compliance effectiveness
GCP Quality Oversight
Serve as the company’s GCP subject matter expert
Provide quality guidance across clinical development activities
Lead quality oversight of CROs, vendors, clinical laboratories, and clinical sites through a risk-based oversight model
Direct GCP inspection readiness activities and serve as a key quality leader during health authority inspections
Support computerized system validation for clinical systems used at clinical vendors, including oversight of validation activities and review of validation documentation
Develop and maintain clinical quality study oversight plans
Compliance and Inspection Readiness
Collaborate with Quality Compliance and Risk Management to develop inspection readiness strategies
Lead clinical deviation investigations, root cause analysis, and CAPA management related to clinical activities
Ensure timely and effective resolution of quality issues
Maintain inspection readiness across clinical activities, documentation, and teams
GDPR & Data Privacy
Collaborate with Legal on the implementation and management of GDPR and data privacy requirements
Support GDPR and data privacy compliance
Partner with Data Management, IT, Legal, and vendors to ensure appropriate handling, storage, and transfer of personal data
Support data protection impact assessments, vendor privacy assessments, and data processing agreements
Cross-Functional Collaboration
Collaborate with and provide quality support to Clinical Operations, Biometrics, Pharmacovigilance, Medical/Clinical Development, Medical Affairs, and Nonclinical, and others as needed to embed quality…