Braveheart Bio

Director

• Serve as a quality leader for Braveheart Bio and will be responsible for manufacturing quality oversight, and inspection readiness for our late-stage clinical program in hypertrophic cardiomyopathy (HCM)
• Execute the manufacturing quality oversight framework for investigational and commercial product to support global Phase 3 execution and to prepare for future regulatory submissions and commercialization activities
• Partner closely with Manufacturing, Regulatory, partners, and CDMOs to ensure best-in-class quality oversight across all programs
• Build a small team as the company grows
• Demonstrate end-to-end oversight of outsourced GMP activities across CDMOs, CMOs, and contract laboratories
• Monitor vendors and ensure compliance with Quality Agreements
• Use risk-based approaches to prioritize oversight activities
• Manage the quality transition from clinical to commercial manufacturing
• Align GMP systems with regulatory commitments and post-approval requirements
• Maintain focus on sustained state of control
• Build and sustain a continuous inspection readiness culture
• Lead teams through mock inspections and document readiness
• Ensure rapid, thorough, and strategic responses to inspection findings
• Work closely with CMC teams to embed quality expectations into the product development lifecycle
• Participate in project team meetings and cross-functional planning activities to ensure quality considerations are integrated into decision-making
• Provide ad hoc quality support across broader GxP activities as business needs evolve
• Support quality systems activities as needed
• Support enterprise quality system activities as needed
• Contribute to cross-functional quality initiatives, inspections, and issue resolution

Director, Quality

• Ensure alignment of key activities & timelines of cross-functional team to successfully set up and supply each clinical trial, including maintaining oversight on performance and issues to ensure study supplies are provided in line with the agreed scope of work and timelines.
• Establish shipping lanes and logistics processes for new clinical trials or new clinical sites including preparation of shipping, importation and exportation documents.
• Coordinate the resolution of sample and product shipment delays and deviations with vendors, internal teams and partners. Proactively identify potential shipment delays and escalate as needed. Perform root cause analysis of shipping issues in order to identify process improvements.
• Serve as the single point of contact for key stakeholders for logistics topics.
• Provide a responsive, effective and successful high level of customer service to Clinical Operations, CMC and Nonclinical partners.
• Participate in cross-functional distribution-related projects and process improvement initiatives.
• Enhance delivery of Braveheart’s CMC objectives by fostering strong CDMO/CRO relationships.
• Use appropriate project management tools to plan and track project deliverables.
• Participate in CMC Team meetings and provide logistics and supply updates to the Vice President of Manufacturing and CMC and SVP of Development Operations.
• Facilitate tracking of the movement of drug, intermediates and samples for analytical testing between external partners.
• Analyze shipping temperature monitoring data and participate/lead investigations for excursions, in close collaboration with Quality.
• Interface between CMC and Clinical Operations to ensure planning, coordination and communication to enable timely supply of materials.
• Assist with CMC project budget planning and tracking, including invoice payments, accruals and reforecasting as needed.
• Assist with circulating RFPs, establishing contracts, amending and approving work programs.

Associate Director – Clinical Supplies Management

Compliance

• Serve as Global Regulatory Lead for the Phase 3 HCM program, leading the development and execution of regulatory strategies that result in successful registration and post-approval commercialization of our HCM asset
• Provide strategic regulatory input and leadership at program governance forums and core team meetings
• Proactively identify regulatory risks and develop mitigation strategies
• Plan, prepare, review, and oversee submissions to regulatory authorities supporting late-stage development and registration readiness
• Serve as the primary point of contact with FDA and other health authorities as applicable
• Lead regulatory agency meetings and coordinate the preparation of supporting meeting materials
• Ensure the content in regulatory submissions is complete, well-written, and meets all applicable requirements for the program’s development phase
• Partner with and support Clinical, Nonclinical, CMC, and Safety & Pharmacovigilance activities, including the review and submission clinical protocols, IBs, DSURs throughout the product life cycle
• Ensure regulatory deliverables, support clinical timelines, quality standards, and compliance expectations
• Maintain broad and current knowledge of regulatory requirements and guidelines across clinical, nonclinical, submission, and compliance domains
• Support the implementation of additional systems and process improvements as needed.

Director, Regulatory Affairs

Medical Director

• 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.

Senior Medical Director

• Lead all aspects of execution and oversight across nonclinical and clinical programs
• Serve as the primary liaison to external CROs, ensuring scientific quality, regulatory compliance, and timely delivery of data
• Partner cross functionally with CMC, Clinical Operations, and Regulatory to support advancement of our phase 3-ready asset
• Manage all CRO relationships related to bioanalysis, including selection, contracting, technical oversight, and performance tracking
• Ensure timely and compliant sample collection, shipping, and analysis in alignment with GxP requirements
• Experience developing population PK models and integrating them into pivotal program planning
• Familiarity with regulatory expectations for Clinical Pharmacology in NDA/MAA filings, including labeling language
• Strong partnership with clinical development, ensuring study protocols incorporate appropriate PK sampling and CDISC-aligned data plans
• Lead the Clinical Pharmacology components of global regulatory interactions (FDA, EMA)
• Alignment of Clinical Pharmacology strategy with cross-functional program priorities and commercial considerations
• Effective communication to simplify complex concepts for clinical investigators, executives, and external partners
• Collaboration with Clinical Operations, Safety, Biometrics, and Regulatory.
• Guiding the company through decision-making (interim analyses, dose adjustments, safety reviews)
• Oversight of high-quality PK sample handling, assay readiness, and data processing workflows
• Building fit-for-purpose processes that scale as the company moves from Phase III to registration
• Operate independently as the sole internal Clinical Pharmacology expert
• Be proactive and resourceful, with the ability to step beyond a narrow functional box when needed
• Influence without direct authority—shape strategy through clarity, data, and presence rather than team size
• Thrive in a fast-moving environment and adjust strategy rapidly as clinical data emerge.

Director, Clinical Pharmacology – DMPK

Project Manager

• The Manager/Senior Manager of Project Management will play a central role in driving the planning, coordination, and execution of Braveheart’s clinical development activities.
• This individual will work closely with functional leaders and team members to develop integrated development plans, anticipate risks, and keep projects moving efficiently toward key milestones.
• As a core facilitator of team operations, this role blends strategic project planning with hands-on execution, ensuring timelines, deliverables, and day-to-day coordination remain on track in a fast-paced, growth-oriented biotech environment.
• The Manager/Senior Manager will structure project work, organize team forums, ensure clear information flow across functions, and bring disciplined follow-through to complex workstreams.
• This role will also contribute to budget planning, operational tracking, and the evolution of project management best practices across the organization.

Senior Manager, Project Management

Program Manager

• Work with the leadership team to develop pipeline strategies and build high-performing teams that can deliver defined business solutions
• Develop and deliver on project plans to guide programs while managing risk, contingencies and/or corrective actions
• Lead and manage the project management function
• Define and direct the technical approach to project management
• Lead and provide effective project/program leadership of the development team to deliver high-quality projects/programs with clear boundaries and outcomes on time and within budget
• Work in partnership with the Leadership Team to develop and implement overall project/program strategy
• Align development plans across Regulatory, Clinical, R&D, Pharmacology-Toxicology and CMC
• Interface with Regulatory Affairs to develop global regulatory strategy and plans
• Provide cross-functional leadership for the strategic planning of integrated development plans for programs, starting at first-in-human through registration
• Co-chair cross-functional project/program team meetings to ensure appropriate action plans are created and implemented
• Set realistic yet aggressive timeframes for achieving objectives with team buy-in and alignment
• Lead cross-functional project/program team(s) to prepare Target Product Profile and global development plan to deliver differentiated products, leveraging the scientific and medical leadership of the Leadership Team
• Define and implement a communication strategy/plan for the program that supports the most effective team empowerment and progress
• Act as an appropriate role model/coach/mentor to facilitate the success and development of individuals within the teams and the team as a whole