Braveheart Bio

Role Description As we advance our myosin inhibitor into Phase 3 clinical development for Hypertrophic Cardiomyopathy (HCM), our Medical Director will serve as a key clinical leader, responsible for shaping and executing the company’s late-stage clinical strategy and ensuring scientific and regulatory excellence through this phase of development. Reporting to our CMO, the (Senior) Medical Director will bring their expertise in Cardiology, ideally with HCM, as well as Phase 3 design and execution. This individual will employ strategic leadership, operational agility, and cross-functional collaboration across Clinical Operations, Regulatory Affairs, Biometrics and other development functions to ensure successful global trial delivery and regulatory readiness. Key Responsibilities - Lead the clinical strategy and execution for the HCM program, including Phase 3 trial design, implementation, and oversight. - Serve as Medical Monitor for assigned clinical studies, ensuring patient safety, data integrity, and protocol adherence across all global sites. - Provide medical and scientific leadership to cross-functional study teams, including Clinical Operations, Regulatory, Biostatistics, and Data Management. - Partner with Regulatory Affairs to support global health authority interactions, including IND/CTA submissions, briefing documents, and responses to regulatory inquiries. - Collaborate with the Chief Medical Officer and senior leadership to define and execute the overall clinical development plan and ensure alignment with corporate strategy. - Lead clinical data interpretation, analysis review, and support preparation of clinical study reports, manuscripts, and scientific presentations. - Engage with external experts, investigators, and key opinion leaders (KOLs) to inform program strategy and strengthen Braveheart Bio’s scientific network in cardiology and HCM. - Contribute to development of risk mitigation strategies, protocol amendments, and study governance processes. - Support internal decision boards and cross-functional portfolio planning as the clinical subject matter expert for the HCM program. Qualifications - M.D. or D.O. degree (board certification in cardiology or related specialty preferred) - Minimum of 6 years of clinical development experience in the biopharmaceutical industry, including leadership of Phase 3 trials - Proven track record of clinical trial design, implementation, and medical oversight within cardiology or a closely related therapeutic area - Experience interfacing with global regulatory authorities and contributing to pivotal submission packages - Demonstrated ability to synthesize complex clinical and scientific data and communicate clearly to internal and external 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 Preferred Experience & Skills - Experience specifically in Hypertrophic Cardiomyopathy (HCM) or broader cardiomyopathy/cardiovascular disorders is strongly preferred - Prior experience as a Global Clinical Lead or equivalent senior role overseeing multicenter, global late-stage programs - Demonstrated success fostering cross-functional collaborations and managing external partnerships or CROs - Knowledge of biomarkers, imaging endpoints, and patient-reported outcomes relevant to cardiovascular diseases - Strong familiarity with regulatory frameworks for pivotal trials (FDA, EMA, PMDA) and BLA/NDA/MAA filings - Strategic thinker with the ability to balance scientific rigor and pragmatic execution in a startup setting Compensation - Base Salary Range: $269,000 - $385,000 - This role is eligible for a competitive total rewards package, including an annual bonus, equity, and a comprehensive benefits offering. Equal Opportunity Employer 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. Braveheart participates in the federal E-Verify program to confirm employment authorization for all new hires. To learn more about E-Verify please review this poster.

Role Description As Braveheart Bio advances its lead small molecule program toward late-stage development, the Head of CMC will serve as a key technical and operational leader, responsible for all Chemistry, Manufacturing, and Controls (CMC) activities across development and supply. Reporting to the executive team, this individual will lead drug substance and drug product process development, manufacturing strategy, and external supply chain execution, while partnering closely with internal cross-functional teams and a network of global CDMOs and CROs. The Head of CMC will play a critical role in ensuring regulatory readiness, technical excellence, and scalable, compliant manufacturing to support clinical development and eventual commercialization. A central focus of the role will be driving commercial readiness and supporting a successful global launch, including: - Process validation - Scale-up to commercial volumes - Qualification of a robust commercial supply network - Delivery of the launch CMC package to support NDA/MAA approval and market entry Qualifications - Ph.D. (or equivalent) in Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or a closely related field; exceptionally strong master’s candidates will be considered - Fifteen-plus years’ experience in the pharmaceutical or biotech industry, with five-plus years’ demonstrated leadership in small molecule process development - Experience with global pharmaceutical/biotech development and manufacturing operations for development-stage small molecule assets - Leadership experience in managing diverse project activities with contract CDMO facilities - Direct experience with successful registrations and commercial launch of novel assets - Hands-on experience leading commercial readiness activities, including PPQ, process and analytical method validation, pre-approval inspection (PAI) readiness, and qualification of commercial-scale supply for global launch - Experience with clinical supply management, process scale-up and technology transfer, cGMPs, and ICH guidelines - Experience with small molecule development programs, from early stage through commercial - Knowledge of cGMP regulations - Hands-on, roll-up-your-sleeves approach, with high sense of urgency and drive for results - Demonstrated communication, problem-solving, and negotiation/decision-making skills - Ability to think outside of the box and challenge the status quo - Natural entrepreneurial spirit with unrelenting dedication to delivering results - Desire to work in a fast-paced, innovative environment - Natural collaborator who enjoys working on a cross-functional team - Ability to travel 10-20%, domestic and/or international Requirements - Direct all aspects (DS/DP) of process development and supply chain operational activities for the company’s programs - Develop and direct strategies for upstream and downstream process development, analytical development, and formulation development - Author and review technical sections for company’s global regulatory submissions - Collaborate with team members to efficiently evaluate, select, and manage contract service providers - Lead end-to-end commercial CMC readiness - Build and qualify the commercial supply network - Oversee the development and maintenance of the budget for assigned program activities - Develop and/or provide technical review of development documents - Play a leadership role in the creation, maintenance, improvement, and compliance with quality system - Contribute to the generation and protection of company intellectual property - Lead, develop, and mentor direct reports - Demonstrate success in a dynamic, interactive, fast-paced, and entrepreneurial environment Benefits - Base Salary Range: $300K - $375K - Eligible for a competitive total rewards package, including an annual bonus, equity, and a comprehensive benefits offering

Role Description The Clinical Trial Management Associate (CTMA) is a key member of the Clinical Operations team and will partner closely with the Clinical Trial Manager (CTM), Senior CTM, and Associate Director, Clinical Operations. The CTMA will support the execution of a global Phase 3 program, with a primary focus on study coordination, documentation, and operational support. Under the supervision of the Associate Director, Clinical Operations or the Senior CTM, the CTMA may manage sites within a region (e.g., EMEA or Americas) and/or vendors (e.g., IRT, eCOA, etc.) - Provide operational and administrative support for day-to-day clinical trial activities, including study start-up, maintenance, and close-out. - Support site start-up activities, including tracking of site start-up components and assisting with site activation readiness. - Accountable for study level tracking at Sponsor (e.g., monitoring visit tracking, sample tracking, patient tracking, site activation tracking, etc.) - Act as a point of contact for CROs and study sites for routine communications and follow-ups, including escalations and engagement. - Assist with coordination of investigator meetings and study-related communications. - Track study timelines, deliverables, and key milestones; proactively follow up on outstanding items. - Maintain internal Clinical Operations systems, trackers, and document repositories. - Prepare and distribute study status updates and meeting minutes and ensure vendors do the same. - Assist with vendor coordination and oversight, including vendor set-up, performance, and deliverable tracking. - May assist with administration of invoice reconciliation, scoping, and change orders, for clinical trial operations. - Support review of study documents (e.g., informed consent forms, regulatory packages) and route for approval. - Maintain and QC the Trial Master File (TMF) and ensure documents are filed in a timely and compliant manner. - Create, maintain, and close out TMFs; play a central role in setup, conduct, and close out of ancillary services. - Facilitate quality reviews and support trending activities. - Facilitate and/or assist in review of CRO monitoring trip reports for completeness and consistency. - Track protocol deviations and support trending activities. - Support data review activities, including tracking queries and assisting with data listings review. - Perform administrative duties in a timely manner as assigned. - Adhere to Clinical Operations processes and SOPs. Qualifications - BS or BA in a relevant scientific discipline or RN (2- or 3-year certificate) - Minimum of 2 years of relevant clinical trial experience - Clinical trial experience in the pharmaceutical or biotechnology industry - Excellent attention-to-detail, interpersonal and presentation skills are a critical asset - Excellent organizational, problem-solving and time management skills - Must be familiar with routine medical/scientific terminology - Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable - Must be familiar with Word, PowerPoint, and Excel (intermediate or higher excel proficiency a plus) - Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision - High energy level, personal productivity, creativity and commitment - Highly adaptable team-player; eager to learn - 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 - This position is for remote work and may require domestic or international travel up to 25% (as needed); valid travel documents must be obtainable Salary Range $100,000 - $135,000 Equal Opportunity Employer 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.

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 Clinical Trial Manager (CTM) is a key member of the Clinical Operations team and will report into the Associate Director, Clinical Operations, partnering closely on the start-up and initiation of a global Phase 3 program. The primary responsibility of the CTM will be regional study management and vendor management. Key responsibilities: - With guidance from the Associate Director, ClinOps, responsibility for day-to-day activities within a region or regions, including site selection, start-up, maintenance, and close-out activities. With guidance, may serve as the key operational contact for Braveheart Bio studies aiding in site selection, study implementation, and ongoing coordination of study sites, either directly or via CROs. - Assist Associate Director, ClinOps with oversight of CRO and set-up of vendors as required, including liaising with Global CRO to ensure timely initiation of study. - Day-to-day contact with counterparts at CRO and/or trial sites, including daily review and identification of potential issues or problems that must be communicated/escalated directly to Associate Director, ClinOps. - Review site Informed Consent Forms and escalate to appropriate individuals, as needed. Assist with regulatory submission package review for submissions within region. - Proactively identify potential operational challenges and, in collaboration with senior team members, provide solutions to ensure study execution remains on track. - Perform accompanied visits (PSSVs, SIVs, RMVs) with CRO CRAs to ensure study procedure conduct is in accordance with SOPs and protocol procedures, and review routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and Monitoring Plan, as required. - With guidance, may assist in review of protocols, informed consents, and case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports. May assist in compilation of investigator brochure appendices under close supervision. - Review of trip reports generated by CRO CRAs for trends and quality issues. - Review protocol deviations and monitor for trends. - Coordinate review of data listings and preparation of interim/final clinical study reports, including resolving data discrepancies. - Provide regular study updates to the appropriate internal stakeholders. - Maintain internal Clinical Operations databases and document repositories. - Perform administrative duties in a timely manner as assigned. - Guide and support junior team members, ensuring alignment on deliverables, timelines, and quality standards. Required experience & skills: - At least 4+ years of relevant experience with a BS or BA in a relevant scientific discipline or an RN (2- or 3-year certificate) - Relevant clinical trial experience in the pharmaceutical or biotechnology industry - Experience as the regional lead for Europe, United States, Latin America, and/or APAC - Excellent attention to detail, interpersonal and presentation skills are a critical asset - Excellent organizational, problem-solving and time management skills - Must be familiar with routine medical/scientific terminology - Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable - Must be familiar with Word, PowerPoint, and Excel (intermediate or higher excel proficiency a plus) - Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision - High energy level, personal productivity, creativity and commitment - Highly adaptable team-player - 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 - This position is for remote work and may require domestic or international travel up to 25% (as needed); valid travel documents must be obtainable. Salary Range: $140,000 - $170,000 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.