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Braveheart Bio

via LinkedIn

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Vice President, Clinical Operations

San Francisco, CA
full-time
Posted 10/18/2025
Verified Source
Key Skills:
Clinical Operations Leadership
Phase 3 Clinical Trial Execution
ICH-GCP, FDA, EMA Compliance
Vendor and CRO Management
Clinical Budget Planning
Cross-functional Collaboration
Strategic Planning
Team Building and Mentorship

Compensation

Salary Range

$180K - 250K a year

Responsibilities

Lead and scale clinical operations for global clinical trials, ensuring quality, compliance, and efficiency while collaborating across functions and managing vendors and budgets.

Requirements

15+ years progressive clinical operations experience in biotech/pharma, Phase 3 trial execution, leadership of clinical teams, regulatory compliance expertise, and strong operational and strategic skills.

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 Vice President of Clinical Operations will provide strategic and operational leadership for all clinical development activities. As a key member of the leadership team, this individual will oversee the planning, execution, and delivery of global clinical trials from early development through pivotal studies and regulatory submissions. Reporting to the Chief Development Officer, the VP will be responsible for building and scaling the Clinical Operations function at Braveheart Bio, fostering a culture of accountability, collaboration, and patient focus. This leader will ensure that all programs are executed to the highest standards of quality, compliance, and efficiency—advancing the company’s mission to bring transformative therapies to patients with HCM. Key responsibilities: • Build, lead, and mentor a high-performing Clinical Operations organization • Provide strategic oversight and operational leadership for the design, initiation, execution, and reporting of all phases of clinical trials • Partner cross-functionally with Clinical Development, Regulatory, Biometrics, CMC, Medical Affairs, and other stakeholders to align operational plans with corporate objectives • Oversee vendor and CRO selection, contract negotiations, and ongoing performance management to ensure delivery of high-quality, on-time, and cost-effective studies • Develop and implement operational processes, SOPs, and best practices to ensure compliance with ICH-GCP, FDA, EMA, and other global regulatory standards • Manage study budgets, forecasts, and resource planning to support efficient execution across programs • Anticipate and mitigate risks to clinical program execution; provide proactive solutions to maintain timelines and quality standards • Represent Clinical Operations at internal governance meetings, executive updates, and external engagements with partners, investigators, and regulators • Contribute to long-range clinical strategy and portfolio planning, providing operational insight to inform development priorities Required experience & skills: • Minimum of a Bachelor’s degree in life sciences or related field • Minimum of 15 years of progressive experience in clinical operations within biotech or pharmaceutical organizations • Direct experience with Phase 3 clinical trial execution • Proven track record of successfully leading global trials from early development through pivotal phases and regulatory submissions • Demonstrated success building and managing Clinical Operations teams in a fast-paced, entrepreneurial, or emerging biotech environment • Deep knowledge of ICH-GCP, FDA, EMA, and other global regulatory requirements • Expertise in vendor oversight, CRO management, and clinical budget planning • Strong leadership presence with the ability to influence and collaborate effectively across functions and levels • Excellent organizational, and problem-solving skills • 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: • Advanced degree (MS, PharmD, PhD) is strongly preferred • Prior experience with cardiovascular and/or rare disease trials is highly desirable • Experience leading Clinical Operations at the VP or Senior Director level in a small to mid-sized biotech • Demonstrated ability to establish scalable infrastructure, systems, and processes for a growing organization • Strategic thinker with a hands-on, roll-up-the-sleeves approach and a passion for improving patient outcomes through innovative therapies • Experience working directly with investigators, regulators, and key external stakeholders • Ability to thrive in Braveheart Bio’s mission-driven, collaborative, and fast-paced environment 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.

This job posting was last updated on 10/21/2025

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