Vice President, Biometrics

External

Braveheartbio · San Francisco, CA

$300K–$375K/yrFull-timeRemote3w ago

Clinical TrialsComplianceGCPLeadershipLeanStatistical Analysis

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About the role

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 Vice President of Biometrics will provide strategic and operational leadership across statistical activities as the company transitions into Phase III clinical trials. This role will be responsible for defining and executing the integrated biometrics strategy, overseeing CRO and vendor partnerships, ensuring data integrity and regulatory readiness, and serving as a key leader on the clinical development team. 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 leadership for biometrics across all clinical development programs, with primary focus on Phase III execution

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

Lead and oversee CROs and external vendors responsible for biostatistics statistical programming and related biometrics activities.

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

Build, mentor, and lead internal biostatistics capabilities over time, as appropriate to company 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

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 remain comfortable with change and ambiguity

Flexible, proactive, and hands-on mindset with a roll-up-your-sleeves, can-do attitude

Preferred experience & skills:

Prior experience serving as a functional or biometrics lead in regulatory interactions with FDA and ex-U.S. health authorities

Experience in cardiovascular, rare disease, or genetically driven conditions

Background in small or mid-sized biotech companies transitioning into late-stage development

Experience building or scaling internal biometrics functions and infrastructure

Familiarity with innovative trial designs and modern statistical methodologies

Base Salary Range: $300K - $375K

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,

Vice President, Biometrics

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