Braveheart Bio

    (Senior) Medical Director

    Braveheart Bio
    Posted 11/25/2025Senior Level
    Full-time
    Healthcare
    Cardiology
    Clinical Development
    Phase 3 Trials
    Clinical Trial Design
    Regulatory Affairs

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    Job Description

    About us:

    Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. Our lead program is a next-generation myosin inhibitor, licensed from Hengrui Pharma, being developed to transform the treatment of hypertrophic cardiomyopathy (HCM)—the most common inherited cardiac disease. Currently in Phase 3 clinical development in China for the more common obstructive form of HCM, our candidate has demonstrated a compelling clinical profile that may position it as a best-in-class therapy with meaningful differentiation. 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:

    As we advance our myosin inhibitor into Phase 3 clinical development for Hypertrophic Cardiomyopathy (HCM), our Medical Director will serve as a key clinical leader, responsible for shaping and executing the company’s late-stage clinical strategy and ensuring scientific and regulatory excellence through this phase of development. Reporting to our CMO, the (Senior) Medical Director will bring their expertise in Cardiology, ideally with HCM, as well as Phase 3 design and execution. This individual will employ strategic leadership, operational agility, and cross-functional collaboration across Clinical Operations, Regulatory Affairs, Biometrics and other development functions to ensure successful global trial delivery and regulatory readiness.

    Key responsibilities:

    • Lead the clinical strategy and execution for the HCM program, including Phase 3 trial design, implementation, and oversight.
    • Serve as Medical Monitor for assigned clinical studies, ensuring patient safety, data integrity, and protocol adherence across all global sites.
    • Provide medical and scientific leadership to cross-functional study teams, including Clinical Operations, Regulatory, Biostatistics, and Data Management.
    • Partner with Regulatory Affairs to support global health authority interactions, including IND/CTA submissions, briefing documents, and responses to regulatory inquiries.
    • Collaborate with the Chief Medical Officer and senior leadership to define and execute the overall clinical development plan and ensure alignment with corporate strategy.
    • Lead clinical data interpretation, analysis review, and support preparation of clinical study reports, manuscripts, and scientific presentations.
    • Engage with external experts, investigators, and key opinion leaders (KOLs) to inform program strategy and strengthen Braveheart Bio’s scientific network in cardiology and HCM.
    • Contribute to development of risk mitigation strategies, protocol amendments, and study governance processes.
    • Support internal decision boards and cross-functional portfolio planning as the clinical subject matter expert for the HCM program.

    Required experience & skills:

    M.D. or D.O. degree (board certification in cardiology or related specialty preferred) Minimum of 6 years of clinical development experience in the biopharmaceutical industry, including leadership of Phase 3 trials Proven track record of clinical trial design, implementation, and medical oversight within cardiology or a closely related therapeutic area Experience interfacing with global regulatory authorities and contributing to pivotal submission packages Demonstrated ability to synthesize complex clinical and scientific data and communicate clearly to internal and external stakeholders 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 specifically in Hypertrophic Cardiomyopathy (HCM) or broader cardiomyopathy/cardiovascular disorders is strongly preferred Prior experience as a Global Clinical Lead or equivalent senior role overseeing multicenter, global late-stage programs Demonstrated success fostering cross-functional collaborations and managing external partnerships or CROs Knowledge of biomarkers, imaging endpoints, and patient-reported outcomes relevant to cardiovascular diseases Strong familiarity with regulatory frameworks for pivotal trials (FDA, EMA, PMDA) and BLA/NDA/MAA filings Strategic thinker with the ability to balance scientific rigor and pragmatic execution in a startup setting

    • 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.

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