Braveheart Bio

Develops cardiac myosin inhibitors for HCM

Associate Director - Quality, Clinical

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeSan Francisco, CA, USAIn-person

About the Job

Requirements

A bachelor's degree in life sciences or a related discipline is required.
At least 8 years of related pharmaceutical or biotechnology quality experience is required.
Strong knowledge of Good Clinical Practice regulations and regulatory expectations for late-stage clinical programs is required.
Experience developing audit strategies, overseeing vendors and contract research organizations, and supporting inspection readiness is required.

Responsibilities

Apply clinical quality strategy for assigned studies and workstreams in alignment with global regulatory requirements and risk-based quality principles.
Serve as a quality partner to clinical teams, proactively identifying, assessing, and mitigating risk.
Serve as the Good Clinical Practice subject matter expert for assigned programs.
Develop and execute clinical quality oversight plans.
Serve as the clinical quality assurance representative on study teams, providing quality input from protocol development through study close-out.
Review protocols, monitoring plans, data management plans, and other key study documents for Good Clinical Practice compliance.
Oversee study quality risk management in line with ICH E6(R3).
Review and trend protocol deviations, assess significant quality events and potential serious breaches, and drive investigations and corrective and preventive actions to effective closure.
Lead Good Clinical Practice inspection-readiness activities for assigned scope and serve as a quality lead during health authority inspections.
Oversee trial master file quality and inspection readiness.
Provide quality oversight of study-specific clinical systems, including electronic data capture, electronic trial master file, interactive response technology, and electronic clinical outcome assessment, to ensure compliance with 21 CFR Part 11, EU Annex 11, and ALCOA+ data-integrity expectations.
Develop and maintain audit strategies and vendor oversight plans for assigned scope.
Lead deviation investigations, root cause analysis, and corrective and preventive action management for assigned scope.
Direct contracted auditors performing investigator site audits, including the risk-based audit plan, report review, finding classification, and corrective and preventive action follow-up.
Work 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.
Work with Quality Compliance and Risk Management to support inspection-readiness initiatives.
Provide quality support across broader Good Practice activities as business needs evolve.

Desired Qualifications

An advanced degree is preferred.
Experience building or scaling a Good Clinical Practice/Good Laboratory Practice quality function in a small or emerging biotechnology company is preferred.
Certified Quality Auditor, Regulatory Quality Assurance Professional–Good Clinical Practice, or ISO Lead Auditor certification is preferred.
Experience with computerized system validation for clinical and nonclinical systems is preferred.

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 Associate Director, Quality owns clinical and nonclinical quality oversight for assigned studies, vendors, and workstreams from end to end, and serves as a senior quality advisor across Braveheart Bio's clinical programs. Reporting to the Director, Quality, this individual will make quality decisions within scope, serve as the primary quality contact for assigned vendors and CROs, and direct the work of contractors or junior staff.

Key responsibilities:

Quality Strategy & Leadership

Applies clinical quality strategy for assigned studies and workstreams, aligned with global regulatory requirements and risk-based quality principles
Serves as a trusted quality partner to clinical teams, proactively identifying, assessing, and mitigating risk
Serves as GCP subject matter expert for assigned programs

Study-Level Quality Oversight

Develops and executes clinical quality oversight plan
Serves as the clinical QA representative on study teams, providing quality input from protocol development through study close-out
Reviews protocols, monitoring plans, data management plans, and other key study documents for GCP compliance
Oversees quality risk management for studies in line with ICH E6(R3)
Reviews and trends protocol deviations, assesses significant quality events and potential serious breaches, and drives investigations and CAPA to effective closure
Leads GCP inspection readiness activities for assigned scope; serves as a quality lead during health authority inspections
Oversees TMF quality and inspection readiness
Provides quality oversight of study-specific clinical systems, including EDC, eTMF, IRT, and eCOA, to ensure compliance with 21 CFR Part 11, EU Annex 11, and data integrity (ALCOA+) expectations

Audit, Oversight, & Compliance

Develops and maintains audit strategies and vendor oversight plans for assigned scope
Leads deviation investigations, root cause analysis, and CAPA management for assigned scope
Directs contracted auditors performing investigator site audits, including the risk-based audit plan, report review, finding classification, and CAPA follow-up

Cross-Functional Collaboration

Works closely with clinical development teams to embed quality expectations into study planning, startup, execution, and closeout
Participates in project team meetings and cross-functional planning activities
Works with Quality Compliance and Risk Management to support inspection readiness initiatives
Provides quality support across broader GxP activities as business needs evolve

Required experience & skills:

Bachelor’s degree in life sciences or related discipline (advanced degree preferred)
Minimum 8 years of related pharma/biotech Quality experience
Strong knowledge of GCP regulations and regulatory expectations for late-stage clinical programs
Experience developing audit strategies, overseeing vendors and CROs, and supporting inspection readiness

Preferred experience & skills:

Experience building or scaling a GCP/GLP quality function in a small or emerging biotech
CQA, RQAP-GCP, or ISO Lead Auditor certification
Experience with computerized system validation for clinical and nonclinical systems

Base Salary Range: $175K - $210K

This role is also eligible for a competitive total rewards package, which may include an annual bonus, equity, and a comprehensive benefits offering.

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, gender, 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.

About the Company

Braveheart Bio

Develops cardiac myosin inhibitors for HCM

Braveheart Bio develops therapies for hypertrophic cardiomyopathy by in-licensing promising drug candidates and advancing them through late-stage clinical trials. Its lead drug, BHB-1893, is a selective small-molecule cardiac myosin inhibitor licensed from Hengrui Pharma for ex-China rights, designed to reduce contractility in heart cells and improve heart performance. The company differentiates itself by pursuing a best-in-class profile with potential improvements in efficacy, safety, and dosing, supported by a high-profile leadership team and investors. Its goal is to bring an approved, globally accessible therapy for HCM that delivers meaningful clinical benefit.

Company size: 51-200
Company stage: IPO
Headquarters: San Francisco, CA
Founded: 2025

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