Director/Senior Director, Clinical Quality

The posting, as Braveheart Bio wrote it

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

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(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
• Demonstrated expertise in GDPR and clinical data-privacy compliance
• Demonstrated experience with computerized system validation for clinical 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 & skills

• Experience in rare disease, cardiovascular, or specialty-disease clinical development
• Experience supporting preparation for major regulatory submissions (NDA/BLA/MAA)
• Prior experience with data privacy frameworks beyond GDPR (e.g., CCPA)
• Audit certification or quality certification (e.g., ASQ)
• Experience with GLP (21 CFR Part 58 and OECD) a plus

Base Salary Range: $200,000 - $290,000

This role is also eligible for a competitive total rewards package, which may include an annual bonus, equity, and a comprehensive benefits offering.

We are an equal opportunity employer.

We are committed to inclusion and diversity, and we do not discriminate on the basis of race, gender, religion, gender, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any characteristic protected under applicable law.

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 .