Braveheart jobs

Senior Principal Programmer San Francisco, CA or Remote or Hybrid 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 Principal Programmer will report into the VP, Biometrics and provide strategic and technical leadership for clinical programming activities across clinical development programs. This individual will oversee CRO programming deliverables, support global regulatory submissions, contribute to ongoing study monitoring, and collaborate closely with Biostatistics, Data Management, Clinical Operations, Regulatory, and external vendors to ensure high-quality, compliant, and timely delivery of clinical data outputs. Key responsibilities: - Oversee CRO programming activities, including SDTM, ADaM, TFLs, define.xml, reviewer's guides, and other clinical study or submission deliverables. - Review CRO programming plans, specifications, datasets, outputs, QC documentation, issue logs, and submission packages. - Ensure programming deliverables are accurate, traceable, reproducible, and compliant with CDISC standards and FDA/EMA expectations. - Serve as the internal programming lead

Clinical Trial Management Associate San Francisco, CA or Remote or Hybrid 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 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.) Key responsibilities: - 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.

Senior Clinical Trial Manager San Francisco, CA or Remote or Hybrid 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 Clinical Trial Manager (Sr. CTM) is a key leader within the Clinical Operations team and will report to the Senior Director, Clinical Operations. The Sr. CTM will be responsible for the end-to-end operational delivery of a study in collaboration with other study leads across the program. This includes providing strategic oversight of study execution, vendor management, financial accountability, and cross-functional alignment. Key responsibilities: - Serve as the study lead for one or more global clinical trials, overseeing day-to-day execution from start-up through close-out (including site activation, enrollment, study conduct, and close-out) under the guidance of the Senior Director, Clinical Operations. - Partner closely with the Clinical Operations study leads on key decisions by providing recommendations, proactively identifying risks, and escalating

(Senior) Medical Director San Francisco, CA or Remote or Hybrid 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: 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. -

Vice President, Biometrics San Francisco, CA or Remote or Hybrid 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 Vice President of Biometrics will provide strategic and operational leadership across statistical activities as the company transitions into Phase III clinical trials. This role will be responsible for defining and executing the integrated biometrics strategy, overseeing CRO and vendor partnerships, ensuring data integrity and regulatory readiness, and serving as a key leader on the clinical development team. The ideal candidate brings deep late-stage expertise, strong cross-functional leadership, and a hands-on mindset well suited for a lean, fast-growing biotech organization. Key responsibilities: - Provide strategic leadership for biometrics across all clinical development programs, with primary focus on Phase III execution - Define and implement an integrated biometrics strategy supporting clinical trial design, data quality, statistical analysis, and regulatory submissions - Serve as a

Head of Chemistry, Manufacturing & Controls (CMC) San Francisco, CA or Remote or Hybrid 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: 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,

Vice President, Drug Safety & Pharmacovigilance San Francisco, CA or Remote or Hybrid 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 Vice President, Drug Safety and Pharmacovigilance will lead and scale the global drug safety and pharmacovigilance function at Braveheart Bio. Reporting into the Chief Medical Officer, the VP is accountable for the safety strategy and integrated benefit-risk profile across the portfolio, with immediate focus on supporting Phase 3 programs and preparing the organization for NDA submission and post-marketing readiness. The VP will partner with an established Senior Director of PV (a direct report) to design the PV operating model, select CRO/PV vendor partners, establish the safety governance framework, and represent Safety in cross-functional and regulatory interactions. This individual will be hands-on while setting strategic direction and has a track record of leveraging external partners to deliver inspection-ready DSPV at