Braveheart Bio is hiring an Associate Director, Clinical Operations to play a key role in executing clinical trials for our late-stage HCM program. Reporting to the Senior Vice President, Development Operations, you will drive the operational execution of the pivotal Phase 3 trial, managing study startup, enrollment, vendor oversight, and cross-functional delivery of milestones.

What You'll Do

Support operational planning, start-up, execution, and close-out activities for Phase 3 clinical studies in HCM.
Oversee CROs, vendors, clinical sites, and external partners to ensure delivery of high-quality data, adherence to timelines, and compliance with GCP and regulatory requirements.
Support development and review of study protocols, operational plans, ICFs, monitoring plans, study manuals, and training materials.
Ensure ongoing inspection-readiness across studies, including documentation, processes, and vendor oversight.
Identify operational risks proactively and implement mitigation strategies that ensure study continuity and quality.
Collaborate with Biometrics, Clinical Pharmacology, and Medical Leads to support data reviews, medical monitoring, and database lock activities.
Represent Clinical Operations on cross-functional study teams; provide operational input into development strategy, timelines, and deliverables.
Partner with Clinical Development, CMC, Regulatory, and Quality to support cross-functional alignment and regulatory submission readiness.
Assist in development of study budgets, forecasting, accrual tracking, and operational metrics.
Lead selection, onboarding, and oversight of CROs, central labs, imaging vendors, and specialty service providers.
Ensure vendors meet contractual obligations, quality expectations, and KPIs while maintaining transparent communication and issue resolution.
Support site engagement strategies, including feasibility, site communications, and escalation management.
Ensure clinical trial conduct complies with ICH/GCP, SOPs, and global regulatory expectations.
Support SOP development, process improvements, and consistent implementation of best practices across the clinical operations function.
Contribute to inspection-readiness activities and support responses to regulatory agency queries as needed.

What We're Looking For

Bachelor’s degree or higher in a scientific discipline (BS, MS, BSRN, or BS + RN certificate).
Minimum of 8 years of relevant clinical operations experience within biotechnology or pharmaceutical development.
Experience leading operational execution for Phase 2 or Phase 3 clinical trials, ideally in cardiovascular, rare disease, or similarly complex indications.
Demonstrated success managing CROs and multiple vendors across global studies.
Strong understanding of ICH/GCP, clinical trial processes, and regulatory expectations for late-stage development.
Proven ability to anticipate operational challenges and implement effective solutions.
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.

Nice to Have

Experience in cardiovascular, heart failure, or HCM clinical trials.
Background in a small or emerging biotech with limited infrastructure.
Experience supporting NDA/BLA-related operational activities.
Familiarity with inspection readiness and agency interactions.
Experience with imaging vendors, central labs, and global site networks.

Team & Environment

Work in a small, fast-paced biotech environment, reporting to the Senior Vice President, Development Operations.

Benefits & Compensation

Compensation: $169K - $268K.

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.