Director of Clinical Affairs - VahatiCor

T45 Labs•Santa Clara, CA

28d•$197,000 - $267,000•Onsite

About The Position

As the Director of Clinical Affairs at VahatiCor, you will be at the forefront of driving and managing the execution of clinical trials. You'll engage in strategic planning, oversee operations, and implement clinical programs, all while ensuring adherence with regulatory standards. Your focus will be on achieving operational excellence by fine-tuning our clinical operations to align seamlessly with our organizational goals. You will champion process improvements to support our clinical initiatives, playing a pivotal role in advancing innovative clinical practices.

Requirements

Bachelor’s or Masters degree in life sciences or related field.
Minimum of 10 years clinical operations, including at least three years in a leadership role within the medical device industry (cardiovascular products preferred).
Hands-on experience and proven success of running early-stage clinical trials within an industry environment.
Expert knowledge of FDA Regulations, ICH Guidelines and GCPs governing the conduct of clinical trials.
Demonstrated and direct experience in vendor and CRO selection/management.
Strong budget management skills and ability to meet deadlines across multiple studies.
Excellent leadership, mentoring, and team-building capabilities.
Exceptional communication and organization skills with the ability to influence cross-functional teams.
Ability to travel up to 25%.
Candidates must be permanently authorized to work in the United States without the need for current or future visa sponsorship.

Responsibilities

Provide strategic direction and operational leadership for clinical programs, ensuring alignment with company objectives and milestones.
Develop clinical operations strategies, timelines, and budgets across multiple clinical studies.
Establish and implement best practices and continuous improvement initiatives to enhance operational efficiency.
Build and maintain relationships with key stakeholders, including clinical investigators, regulatory bodies, CROs, and vendors.
Develop and maintain study budgets.
Direct the planning, execution, and management of clinical studies to ensure completion on time, within budget, and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines.
Track study performance metrics, including enrollment rates, site performance, and financial forecasts, identifying and resolving deviations proactively.
Develop and review clinical trial documents, such as protocols, informed consent forms, monitoring plans, and clinical databases.
Ensure the integrity of the Trial Master File (TMF) and oversee documentation audits as needed.
Evaluate and select clinical vendors, including CROs, and negotiate contracts in collaboration with legal and finance teams.
Provide oversight of investigational product management, including accountability and reconciliation processes.
Manage and mentor a team of Clinical Research Associates (CRAs) and other clinical staff to ensure professional growth and performance excellence.
Lead cross-functional meetings, ensuring clear communication and timely follow-up on action items.
Foster a culture of accountability, collaboration, and innovation within the clinical operations team.
Ensure clinical trials comply with FDA regulations, ICH/GCP guidelines, and ethical standards.
Proactively identify and resolve compliance risks, working closely with quality assurance teams.
Support audits and regulatory inspections, preparing teams and documentation as required.