Director/Senior Director, Clinical Quality

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.