Director/Senior Director, Clinical Quality

Key skills

• GCP

Job description

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 expectations into study planning, startup, execution, and closeout

Participate in project team meetings and cross-functional planning activities to ensure quality considerations are integrated into decision-making

Broad GxP Quality Support (As Needed)

Provide ad hoc quality support across broader GxP activities as business needs evolve

Contribute to cross-functional quality initiatives, inspections, and issue resolution

Required experience & skills:

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

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.

Apply on the official Braveheartbio careers page

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