Director/Senior Director, Clinical Quality

Braveheart Bio•San Francisco, CA

About The Position

Braveheart Bio is a clinical-stage biopharmaceutical company developing therapies for hypertrophic cardiomyopathy (HCM) and other serious cardiovascular diseases. Its lead candidate, BHB-1893, is a next-generation oral small-molecule cardiac myosin inhibitor being developed for obstructive and non-obstructive HCM. The Director/Senior Director of Clinical Quality will be a senior quality leader responsible for clinical quality oversight and inspection readiness for Braveheart Bio’s late-stage HCM clinical program. Reporting to the Vice President, Quality, this person will establish and execute the clinical oversight framework for global Phase 3 development, guide clinical development teams, and prepare the organization for future regulatory submissions and commercialization. The role partners closely with Clinical Operations, Regulatory, Biometrics, Pharmacovigilance, and external CRO and vendor partners. The position may build and lead a small quality team as the company grows. It is a hands-on, strategic, foundational role at a lean biotech entering late-stage development.

Requirements

Bachelor’s degree in life sciences, nursing, or a related discipline.
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, including GCP, GLP, GVP, and 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 and a collaborative, team-oriented approach.
Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity.
Flexible, proactive, hands-on mindset with a roll-up-your-sleeves, can-do attitude.

Nice To Haves

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, such as CCPA.
Audit certification or quality certification, such as ASQ.
Experience with GLP (21 CFR Part 58 and OECD).

Responsibilities

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.
Partner with clinical teams to identify, assess, and mitigate risks, and drive continuous improvement in quality culture, execution, and compliance.
Serve as the company’s GCP subject matter expert and provide quality guidance across clinical development activities.
Lead risk-based quality oversight of CROs, vendors, clinical laboratories, and clinical sites.
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.
Collaborate with Quality Compliance and Risk Management on inspection-readiness strategies.
Lead clinical deviation investigations, root-cause analysis, and CAPA management; ensure quality issues are resolved effectively and on time.
Maintain inspection readiness across clinical activities, documentation, and teams.
Collaborate with Legal on GDPR and data-privacy requirements and support related 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.
Provide quality support to Clinical Operations, Biometrics, Pharmacovigilance, Medical/Clinical Development, Medical Affairs, Nonclinical, and other functions as needed.
Participate in project-team meetings and cross-functional planning to integrate quality considerations into study planning, startup, execution, and closeout.
Provide ad hoc quality support across broader GxP activities and contribute to cross-functional quality initiatives, inspections, and issue resolution.