Braveheart Bio
Vice President, Clinical Operations
Braveheart Bio, San Francisco, California, United States, 94199
Vice President of Clinical Operations
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.
Base pay range $328,000.00/yr - $375,000.00/yr
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.
#J-18808-Ljbffr
Base pay range $328,000.00/yr - $375,000.00/yr
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.
#J-18808-Ljbffr