Vice President, Biometrics

About UsBraveheart 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 RoleThe 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.Key ResponsibilitiesProvide strategic leadership for biometrics across all clinical development programs, with primary focus on Phase III executionDefine and implement an integrated biometrics strategy supporting clinical trial design, data quality, statistical analysis, and regulatory submissionsServe as a core member of the clinical leadership team, partnering closely with Clinical Operations, Data Management, Regulatory Affairs, Safety, and Medical AffairsLead 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 reportsEnsure data integrity, statistical rigor, and compliance with GCP, ICH, and global regulatory requirementsProvide strategic input into study design, endpoint selection, sample size calculations, and adaptive or innovative trial methodologies as appropriateSupport regulatory interactions and submissions, including briefing documents, responses to health authority questions, and advisory committee preparationsEstablish scalable biometrics processes, standards, and SOPs to support late-stage development and future pipeline growthBuild, mentor, and lead internal biostatistics capabilities over time, as appropriate to company growthRequired Experience & SkillsBachelor’s degree or advanced degree, ideally in biostatistics, statistics, mathematics, or a related quantitative disciplineMinimum of 12 years of progressive experience in biostatistics within the biotechnology or pharmaceutical industrySignificant experience leading biostatistics activities for Phase III clinical trials and regulatory submissionsDemonstrated success managing CROs and external vendors in a late-stage development environmentProven track record as a strategic biometrics leader, contributing substantively to complex study designs, endpoint development, and statistical strategy across global development programs; able to provide sharp, on-your-feet thinking in real-time discussions with regulators, KOLs, and cross-functional teams, while maintaining a roll-up-your-sleeves approach to engage directly with protocols, analysis plans, and data when needed.Strong understanding of global regulatory expectations related to clinical data, statistical analyses, and inspection readinessProven ability to operate strategically while remaining hands-on in a lean organizationStrong written and verbal communication skills with a collaborative, team-oriented approachAbility to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguityFlexible, proactive, and hands-on mindset with a roll-up-your-sleeves, can-do attitudePreferred Experience & SkillsPrior experience serving as a functional or biometrics lead in regulatory interactions with FDA and ex-U.S. health authoritiesExperience in cardiovascular, rare disease, or genetically driven conditionsBackground in small or mid-sized biotech companies transitioning into late-stage developmentExperience building or scaling internal biometrics functions and infrastructureFamiliarity with innovative trial designs and modern statistical methodologiesBase Salary Range: $300K - $375KWe 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.