Director of Clinical Affairs (Hybrid) (San Francisco, CA)Summary:
The Director of Clinical Affairs plays a key role in aligning clinical programs with commercial objectives, ensuring successful planning, management, and execution of clinical trials. This position involves maintaining thorough knowledge of US and international regulatory requirements, Good Clinical Practices (GCPs), and relevant product knowledge. The role requires strong leadership, strategic decision-making, and operational expertise in clinical trial management.
Key Responsibilities: Provide strategic input and operational oversight for clinical trials, ensuring adherence to timelines, budgets, and quality standards.Contribute to trial design, including protocol development, case report forms, trial master file management, and timeline planning.Lead the selection, qualification, and contracting of investigators, sites, and vendors for trial conduct.Train internal teams, study investigators, and site personnel on trial protocols and product performance standards.Oversee trial procedures to ensure compliance and mitigate risks associated with study devices.Attend clinical cases for data collection and ensure patient recruitment, enrollment, and site initiation are on track.Identify and resolve clinical study issues, developing solution matrices to address challenges.Manage regulatory and ethics reporting requirements, support Regulatory Affairs in submissions, and ensure clear documentation for regulatory and publication purposes.Review and track clinical trial expenses, providing monthly accruals to accounting and managing budgets for all clinical projects.Build and manage relationships with key internal and external stakeholders.Recruit, manage, and develop the Clinical Affairs team, setting objectives and performance goals aligned with strategic priorities.Qualifications: BS, BA, BSN, RN, or higher in Life Sciences or a related field.10+ years of experience in the medical device industry, preferably in Cardiology, with 5+ years in clinical trial management for class II and III devices.Experience in IDE clinical trials and regulatory submissions, with a background in startup environments a plus.Proven experience managing CROs, core labs, and safety committees (e.g., DSMB, CEC).Knowledge of cardiovascular devices and pathophysiology; expertise in GCP, ICH, and FDA/international regulations.Strong skills in project management, resource management, budgeting, and strategic planning.Proficient with clinical data capture systems, web-based trial management tools, and MS Office.Ability to collaborate effectively with cross-functional teams and stakeholders, including senior leadership.Willingness to travel up to 30% domestically and internationally; some lifting (10-15 pounds) may be required.This is a full-time position.
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