Bachelor's degree in life sciences, nursing, or related discipline; advanced degree preferred
At least 10 years of GCP quality experience, particularly in global clinical development
Strong knowledge of global GxP regulations and regulatory expectations for late-stage clinical programs
Proven success in establishing clinical oversight in small or emerging biotech environments
Expertise in GDPR and clinical data-privacy compliance
Experience with computerized system validation in regulated environments
Strong communication skills with a collaborative approach
Responsibilities
Lead clinical quality strategy aligned with regulatory requirements and business priorities
Establish quality practices for late-stage development and inspection readiness
Serve as a trusted quality partner to clinical teams, identifying and mitigating risks
Drive continuous improvement to enhance quality culture and compliance effectiveness
Provide quality guidance across clinical development activities
Lead oversight of CROs, vendors, and clinical sites using a risk-based model
Collaborate with Quality Compliance to develop inspection readiness strategies
Benefits
Eligible for a competitive total rewards package including annual bonus and equity
Comprehensive benefits offering
Full Job Description
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.
