Senior Medical Director
Braveheart Bio
full-time
Posted on:
Location Type: Hybrid
Location: San Francisco • California • United States
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Salary
💰 $269,000 - $385,000 per year
Job Level
About the role
- 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.
Requirements
- 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
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical trial designimplementationmedical oversightdata interpretationclinical data analysisrisk mitigation strategiesprotocol amendmentsbiomarkersimaging endpointspatient-reported outcomes
Soft Skills
leadershipcommunicationcollaborationteam-orientedadaptabilityproactive mindsetstrategic thinkingproblem-solvinginterpersonal skillsflexibility
Certifications
M.D.D.O.board certification in cardiology