Vice President and Head of Biometrics

About the role

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 Vice President and Head of Biometrics will serve as the functional leader for the Biometrics organization at Braveheart Bio, providing strategic and operational leadership across Biostatistics, Statistical Programming, and Data Management. This executive will define and execute the company's integrated biometrics strategy across all clinical development programs, lead the internal biometrics organization, oversee CROs and strategic partners, and ensure high-quality, submission-ready deliverables that support global regulatory filings. The ideal candidate brings deep late-stage expertise, strong cross-functional leadership, and a hands-on mindset well-suited for a lean, fast-growing biotech organization.

Responsibilities

• Provide strategic and operational leadership for the entire Biometrics organization, including Biostatistics, Statistical Programming, and Data Management across all clinical development programs, with primary focus on Phase III execution
• Build, mentor, and lead internal biostatistics capabilities over time, as appropriate to company growth
• Define and execute an integrated biometrics strategy across all clinical development programs from Phase 2 through registration
• Define and implement an integrated biometrics strategy supporting clinical trial design, data quality, statistical analysis, and regulatory submissions
• Serve as a core member of the clinical leadership team, partnering closely with Clinical Operations, Data Management, Regulatory Affairs, Safety, and Medical Affairs to proactively identify risks and support development decisions
• Lead and oversee CROs and external vendors responsible for biostatistics statistical programming and related biometrics activities
• Drive organizational planning, hiring, mentoring, succession planning, and capability development across the Biometrics function
• Oversee development and review of key deliverables including SAPs, DMPs, CRFs, TFL shells, interim analyses, database locks, and clinical study reports
• Ensure data integrity, statistical rigor, and compliance with GCP, ICH, and global regulatory requirements
• Provide strategic input into study design, endpoint selection, sample size calculations, and adaptive or innovative trial methodologies as appropriate
• Support regulatory interactions and submissions, including briefing documents, responses to health authority questions, and advisory committee preparations
• Establish scalable biometrics processes, standards, and SOPs to support late-stage development and future pipeline growth
• Required experience & skills:
• Bachelor's degree or advanced degree, ideally in biostatistics, statistics, mathematics, or a related quantitative discipline
• Minimum of 12 years of progressive experience in biostatistics within the biotechnology or pharmaceutical industry
• Experience leading multidisciplinary Biometrics organizations encompassing Biostatistics, Statistical Programming, and Data Management
• Demonstrated success building, mentoring, and developing high-performing biometrics teams in a growing biotechnology organization
• Significant experience leading biostatistics activities for Phase III clinical trials and regulatory submissions
• Demonstrated success managing CROs and external vendors in a late-stage development environment
• Strong understanding of global regulatory expectations related to clinical data, statistical analyses, and inspection readiness
• Proven ability to operate strategically while remaining hands-on in a lean organization
• Strong written and verbal communication skills with a collaborative, team-oriented approach
• Ability to thrive in a fast-paced, dynamic environment and

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