Braveheart Bio

Lead and oversee the clinical data management strategy for late-stage trials, ensuring data quality, vendor coordination, and regulatory compliance. | Requires at least 8 years in clinical data management supporting Phase III trials, with strong CRO oversight and experience with data standards and systems. | About us: 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 role: The Director/Sr. Director, Data Management is responsible for ensuring the integrity, quality, and timely delivery of all clinical trial data across our cardiovascular portfolio. This role will be responsible for developing and executing data management strategy across late-stage clinical programs, with a strong emphasis on vendor oversight, data quality, inspection readiness, and cross-functional collaboration. The ideal candidate brings deep hands-on data management expertise, thrives in a lean and fast-moving biotech environment, and is comfortable operating both strategically and tactically. This role is accountable for the development and implementation of a robust data management strategy, including the oversight of internal teams and external vendors (CROs). The ideal candidate requires a detailed knowledge of clinical data management processes, platforms, software, clinical trial databases, and the pharmaceutical drug development process. Key responsibilities: Lead the end-to-end clinical data management strategy for Phase 3 and late-stage clinical trials Set up data management vendors as required, including authoring of RFPs, reviewing and negotiating data management budgets and contracts, and liaising with study management CRO to ensure site training and timely initiation Provide hands-on oversight of CROs and external data management vendors, ensuring delivery against timelines, quality, and budget Serve as the primary data management point of contact for internal cross-functional teams including Clinical Operations, Biostatistics, Regulatory, Safety, and Medical Affairs Oversee development, review, and approval of key data management deliverables including DMPs, CRFs, edit checks, data transfer specifications, overall medical coding strategy and database lock documentation Ensure high standards for data integrity, quality, and compliance with GCP, regulatory requirements, CDASH, CDISC and inspection readiness expectations Ensure CRO-executed data management activities support reliable interim reviews, safety monitoring, and final analyses. Coordinate the ongoing data review activities and proactively identify data risks and implement mitigation strategies to support on-time, high-quality study execution. Define and maintain critical data and processes, review and monitor key risk indicators (KRIs) and quality tolerance limits (QTLs) Partner closely with Biostatistics to support interim analyses, database locks, and final clinical study reports Support regulatory submissions and responses related to clinical data Contribute to long-term clinical systems planning and scalability as the organization grows Establish and maintain data management SOPs, processes, and standards appropriate for a growing late-stage organization Required experience & skills: Bachelor’s degree in life sciences, data sciences, or a related field At least 8 years of progressive experience in clinical data management within the biotechnology or pharmaceutical industry Direct experience supporting Phase III clinical trials, including late-stage database locks and regulatory submissions Strong CRO and vendor oversight experience, with a track record of driving accountability and quality Hands-on experience with EDC systems, data standards, and clinical data workflows Demonstrated ability to work cross-functionally in a lean, fast-paced development environment 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: Advanced degree in a scientific or quantitative discipline Experience in cardiovascular and/or rare disease clinical development Experience in SAS, R or Python programming Prior experience in a small or mid-sized biotech environment transitioning into late-stage development Exposure to regulatory inspections and health authority interactions related to clinical data Experience helping build or scale data management functions and infrastructure Base Salary Range: $225K - $286K 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, color, marital status, veteran status, disability status, national origin, or any characteristic protected under applicable law.

Manage and coordinate clinical development projects, ensuring milestones are met through detailed planning, risk management, and stakeholder communication. | Requires 6+ years in biotech/pharma project management, proficiency with project management tools, and strong communication skills. | Note: The job is a remote job and is open to candidates in USA. Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. The Manager/Senior Manager of Project Management will drive the planning, coordination, and execution of clinical development activities, ensuring projects progress efficiently toward key milestones while collaborating with functional leaders and team members. Responsibilities • Manage one or more clinical-stage projects, partnering with functional leaders to define project goals, integrated development plans, and key deliverables • Create, maintain, and continuously update detailed project timelines (e.g., Gantt charts, trackers, dashboards), identifying critical path activities, dependencies, and resource constraints • Monitor progress against plans; proactively identify risks, delays, or issues and recommend practical mitigation strategies and next steps • Drive disciplined follow-up on action items and ensure accountable owners deliver on commitments • Chair and support project team meetings, including agenda development, facilitation, preparation of high-quality meeting minutes, and tracking of decisions and action items • Schedule, organize, and facilitate cross-functional sub-team meetings and ad-hoc working groups in partnership with functional leaders • Ensure consistent, accurate flow of information across functions (Clinical, Regulatory, R&D, CMC, Finance, and others) to maintain alignment on priorities, timelines, and dependencies • Serve as a central point of coordination to keep teams aligned and project execution moving forward • Prepare project materials, summaries, and status updates for internal stakeholders and leadership forums • Coordinate and draft monthly project status reports and other program-level updates • Produce clear, concise timeline visuals and presentation materials to support team discussions and leadership decision-making • Maintain organized, version-controlled project documentation that serves as a single source of truth for teams • Interface with Finance and functional leaders to support budget planning, tracking, and forecasting • Assist with resource planning, vendor coordination, and operational tracking as projects evolve • Identify operational gaps or execution bottlenecks and propose practical, scalable solutions • Contribute to the development and refinement of project management best practices, tools, templates, and processes • Operate effectively in a fast-paced, startup environment characterized by evolving priorities, limited structure, and ambiguity • Demonstrate comfort working with imperfect information while maintaining disciplined execution and accountability • Bring a proactive, problem-solving mindset with a hands-on, roll-up-your-sleeves approach Skills • Bachelor's degree in physical or life sciences or a related discipline; advanced degree or MBA preferred • At least 8 years of biotechnology or pharmaceutical industry experience with a bachelor's degree, or at least 6 years with a master's degree • Direct, hands-on experience in project planning, execution, and management across complex, cross-functional programs • Strong proficiency with project management methodologies and tools (e.g., Smartsheet, MS Project, Asana, Monday.com, or similar) • Highly organized with exceptional attention to detail and strong analytical and problem-solving skills • Excellent written and verbal communication skills, with the ability to influence and drive results without formal authority • Ability to manage multiple priorities, operate effectively amid ambiguity, and maintain momentum in a fast-paced environment • Proven ability to collaborate across functions and maintain alignment among diverse 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 • Project Management certification (PMP or equivalent) • Experience working in a startup or early-stage biotech environment Company Overview • Braveheart Bio is a clinical-stage biotechnology company focused on developing precision therapies in the cardiovascular disease space. It was founded in 2025, and is headquartered in San Francisco, California, USA, with a workforce of 2-10 employees. Its website is https://www.braveheart.bio/.