Braveheart Bio · 1 month ago
(Senior) Medical Director
San Francisco, CA or Remote or Hybrid
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
6+ years expBraveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. The (Senior) Medical Director will serve as a key clinical leader responsible for shaping and executing the company’s late-stage clinical strategy, ensuring scientific and regulatory excellence throughout Phase 3 development for Hypertrophic Cardiomyopathy (HCM).
BiotechnologyLife ScienceTherapeutics
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
Qualification
Required
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 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
Company
Braveheart Bio
Braveheart Bio is a clinical-stage biotechnology company focused on developing precision therapies in the cardiovascular disease space.
2-10 employees
Funding
Current Stage
Early StageTotal Funding
$185M2025-11-05Series A· $185M
Recent News
2026-01-06
2025-12-16
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