About this opportunity
Braveheart Bio lists this Director, Quality (Clinical) opportunity in oregon, Wisconsin. Review the employer’s description below for duties, qualifications and application requirements.
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 of Quality will serve as a senior quality leader for Braveheart Bio and will be responsible for clinical quality oversight, clinical data integrity, GCP inspection readiness, and support of nonclinical quality activities as needed for our late‑stage clinical program in hypertrophic cardiomyopathy (HCM). Reporting to the Vice President, Quality, this individual will 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 is a high‑exposure role requiring a senior quality leader who can independently evaluate complex clinical quality issues, identify material risks, and make well‑supported recommendations that preserve data integrity, subject protection, regulatory compliance, and inspection readiness. This leader will partner closely with Clinical Development, Regulatory, Biometrics, PV, Data Management, Medical, Legal and external CRO and vendor partners to ensure effective, inspection‑ready clinical quality oversight across all programs. The 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, while supporting non‑clinical quality activities as needed
Establish fit‑for‑purpose quality practices that support late‑stage development, clinical data integrity, inspection readiness, and regulatory submissions. Serve as a trusted quality partner to clinical and nonclinical teams, proactively identifying, assessing, and mitigating risk.
Provide clear, well‑supported quality recommendations to cross‑functional teams and senior leadership, including appropriate escalation of material risks and proposed paths to resolution.
Drive continuous improvement to strengthen quality culture, streamline execution, and improve compliance effectiveness
GCP/GLP Quality Oversight
Serve as the company’s GCP and GLP subject matter expert
Provide quality guidance across nonclinical and clinical development activities
Develop and execute clinical quality oversight plans, including study‑level, CRO, vendor, site, system, and data‑focused oversight activities
Lead quality oversight of clinical trials using a risk‑based model
Provide quality oversight of clinical trial conduct, protocol compliance, informed consent, investigator/site compliance, safety reporting interfaces, TMF quality, essential documents, monitoring quality, and issue escalation
Assess clinical quality and data integrity risks including adjudication processes, data transfer, and data reconciliation
Support computerized system validation for clinical and nonclinical systems, including oversight of validation activities and review of validation documentation
Evaluate clinical computerized systems and data flows for data integrity risk
Oversight & Compliance
Manage or support targeted clinical oversight activities, including investigator site audits, clinical system/process audits, data focused reviews, and pre‑inspection assessments, as needed. Lead deviation investigations, root cause analysis, and CAPA management related to clinical and nonclinical activities.
Ensure timely and effective resolution of quality issues
Maintain inspection readiness across clinical and nonclinical activities, documentation, systems, vendors, and teams, in coordination with broader inspection readiness activities
Data Integrity & Clinical Data Quality
Review and interpret clinical quality signals, including protocol deviations, monitoring findings, audit findings, data discrepancies, CAPAs, TMF gaps, safety reporting, and vendor performance trends
Partner with other functions and vendors to identify risk areas and develop mitigation strategies
Cross‑Functional Collaboration
Work closely with clinical development teams 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
Serve as an independent quality voice, able to challenge assumptions, identify gaps, and drive resolution while maintaining effective working relationships
Communicate quality issues clearly and concisely, including the potential impact, recommended actions, and rationale for escalation or resolution
GxP Quality Support (As Needed)
Provide ad hoc quality support across broader GxP activities as business needs evolve
Support enterprise quality system activities as needed
Contribute to cross‑functional quality initiatives, inspections, and issue resolution
Required Experience & Skills
Bachelor’s degree in life sciences, health sciences or related discipline; advanced degree preferred
Demonstrated understanding of hospital and clinical care environments, gained through direct healthcare experience (e.g., nursing, allied health, or medical background) and/or experience supporting clinical trials in academic medical centers, hospitals, CROs, or the biopharmaceutical industry
At least 10 years of GxP quality experience, including deep experience in GCP oversight and global clinical development
Strong knowledge of global GxP regulations (GCP, GLP, GMP, GVP, GDP as applicable) and regulatory expectations for late‑stage clinical programs
Proven success establishing and executing clinical and nonclinical oversight in a small or emerging biotech environment
Experience developing audit strategies, overseeing vendors and CROs, and supporting inspection readiness and regulatory interactions
Experience developing clinical quality oversight plans, including study, CRO, site, system, and focused data evaluation
Demonstrated ability to independently assess complex clinical quality issues and develop well‑supported recommendations that are scientifically, operationally, and regulatorily sound
Demonstrated ability to evaluate clinical data integrity, endpoint reliability, documentation quality, monitoring effectiveness, vendor data flows, and inspection readiness of clinical trial data
Demonstrated experience with computerized system validation for clinical and nonclinical systems in a regulated environment
Ability to assess risk, solve complex problems, and implement practical, scalable quality solutions
Strong written and verbal communication skills with a collaborative, team‑oriented approach
Strong quality judgment, including the ability to identify material clinical quality risks, escalate appropriately, and drive issues to resolution across functions and external partners
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)
Experience with nonclinical quality oversight, GLP compliance, or nonclinical vendor oversight
Working knowledge of GDPR and clinical trial data privacy requirements
Audit and/or quality certification (e.g., CQA, RQAP‑GCP, ISO Lead Auditor)
Experience with ICH E6(R3), risk‑based quality management, centralized monitoring, quality tolerance limits, and critical‑to‑quality factors
Experience evaluating CRO and vendor data integrity, including data transfers and transformations
Base Salary Range: $195,000 - $230,000
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, 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.
#J-18808-Ljbffr
Worksite address
oregon, WI, 53575, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.