Director/Senior Director, Clinical Quality

The role

The Director/Senior Director of Clinical Quality will provide clinical quality oversight and maintain inspection readiness for late-stage clinical programs in hypertrophic cardiomyopathy. This leader will establish clinical oversight frameworks, guide clinical development teams, and partner with cross-functional teams and external vendors.

What you will do

• Lead clinical quality strategy aligned with global regulatory requirements and business priorities
• Establish quality practices to support late-stage development and inspection readiness
• Serve as the company GCP subject matter expert
• Lead quality oversight of CROs, vendors, clinical laboratories, and clinical sites
• Direct GCP inspection readiness activities and serve as a leader during health authority inspections
• Support computerized system validation for clinical systems used at clinical vendors
• Develop and maintain clinical quality study oversight plans
• Lead clinical deviation investigations, root cause analysis, and CAPA management
• Collaborate with Legal on GDPR and data privacy implementation and management
• Provide quality support to Clinical Operations, Biometrics, Pharmacovigilance, and other departments

Required qualifications

• Bachelor’s degree in life sciences, nursing, or related discipline
• At least 10 years of GCP quality experience
• Deep experience in GCP oversight, global clinical development, and late stage development
• Strong knowledge of global GxP regulations (GCP, GLP, GVP, GDP as applicable)
• 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

Nice to have

• Advanced degree
• 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)

Benefits

• Annual bonus
• Equity
• Comprehensive benefits offering

Before you apply

• Braveheart participates in the federal E-Verify program to confirm employment authorization for all new hires

About the company

Braveheart Bio is a clinical-stage biopharmaceutical company focused on developing therapies for patients with hypertrophic cardiomyopathy (HCM) and other serious cardiovascular diseases.