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Braveheart Bio · 1 month ago

Associate Director, Clinical Operations

United States

Full-time

Remote

Lead/Staff, Director/Executive

$169K/yr - $268K/yr

8+ years exp

Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. The Associate Director, Clinical Operations will be responsible for the execution of clinical trials for the late-stage HCM program, ensuring operational execution and collaboration with various teams to drive trial success.

BiotechnologyLife ScienceTherapeutics

Responsibilities

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

Qualification

Clinical operations experiencePhase 3 clinical trialsCRO managementICH/GCP complianceScientific degreeRegulatory expectationsProactive mindsetCommunication skillsTeam-oriented approach

Required

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