Braveheart Bio

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

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

Senior Medical Director

Director, Clinical Pharmacology – DMPK

Senior Manager, Project Management

Senior Director, Program Management