Braveheart Bio

Compensation

Full Description

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 Senior Director, Clinical Operations will serve as a senior operational leader, accountable for the strategy, planning, and execution of Braveheart Bio’s late-stage HCM clinical trials. Reporting into the Senior Vice President, Development Operations, this individual will lead the end-to-end operational delivery of the pivotal Phase 3 program, ensuring seamless study startup, country and site strategy, enrollment performance, vendor and CRO leadership, and milestone execution across a global trial footprint. This role requires deep expertise in late-stage clinical operations, proven success leading complex global trials, and the ability to operate both strategically and hands-on in a small, fast-paced biotech setting. The Senior Director will partner closely with Clinical Development, Regulatory, Biometrics, Clinical Pharmacology, CMC, and Quality to drive operational alignment, executional excellence, and program progress. The Senior Director will also manage and mentor clinical operations team members, including the Associate Director, to ensure scalable operational capabilities as the program advances. Key responsibilities: Clinical Trial Leadership & Execution Lead the operational strategy, planning, start-up, execution, and close-out activities for the pivotal Phase 3 clinical trial in HCM Drive country and site selection strategies, enrollment forecasting, timeline development, and operational scenario planning Provide senior-level leadership to CROs, vendors, sites, and other external partners to ensure delivery of high-quality operational output and adherence to program timelines Lead development and review of study protocols, operational plans, ICFs, monitoring plans, study manuals, and training materials Maintain proactive oversight of operational risks, enrollment challenges, and program-level bottlenecks, ensuring timely mitigation and cross-functional alignment Oversee operational aspects of data reviews, database lock planning, and preparation for regulatory submissions in close partnership with Clinical Development and Biometrics Cross-Functional & Program Leadership Serve as the senior Clinical Operations representative on program teams and governance forums, providing strategic input into development plans, timelines, and program decisions Partner closely with Clinical Development, Regulatory, CMC, and Quality to ensure program-wide operational readiness and support critical-path activities for Phase 3 and NDA preparation Lead development and management of study budgets, resource models, accrual tracking, and operational performance metrics Drive cross-functional coordination to ensure alignment across critical workstreams including safety, biostatistics, medical monitoring, and clinical pharmacology Team Leadership & Management Manage, mentor, and develop Clinical Operations team members, including the Associate Director, fostering a culture of accountability, operational rigor, and continuous improvement Provide coaching, guidance, and career development to support team growth and scalable operational capabilities Champion operational excellence and consistency across processes, documentation, and execution frameworks Vendor & Site Leadership Lead selection, contracting, onboarding, and governance of CROs, central labs, imaging vendors, and other specialty partners Establish and maintain vendor oversight structures, including KPIs, dashboards, governance meetings, and escalation pathways Oversee global site engagement strategies, including feasibility, site communications, performance tracking, and issue resolution to ensure high-performing study sites Compliance, Quality & Process Excellence Ensure clinical trial conduct meets ICH/GCP, SOPs, and global regulatory standards Drive SOP development, operational process optimization, and implementation of best practices across the Clinical Operations function Lead inspection readiness activities for Clinical Operations and support responses to regulatory agency inquiries Required experience & skills: Bachelor’s degree or higher in a scientific discipline (BS, MS, BSRN, or BS + RN certificate) Minimum of 12 years of relevant clinical operations experience within biotechnology or pharmaceutical development Significant experience leading global Phase 3 clinical trials, ideally in cardiovascular, rare disease, or other complex indications Demonstrated success overseeing CROs and multiple global vendors in late-stage programs Proven ability to build operational strategy, lead teams, and drive execution in a small or emerging biotech 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: Experience in cardiovascular, heart failure, or HCM clinical trials Background in a small or emerging biotech with limited infrastructure Experience supporting NDA/BLA-related operational activities Familiarity with inspection readiness and agency interactions Experience with imaging vendors, central labs, and global site networks Base Salary Range: $253K - $303K 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.