Director of Clinical Affairs

Title: Director, Clinical Operations

Status: Full-time, Exempt

Reports to: VP, Clinical Affairs

Role Summary

As the Director of Clinical Operations, you will lead and oversee the execution of clinical trials across T45 Labs’ portfolio of companies. This role is responsible for strategic planning, operational leadership, and successful delivery of clinical programs in compliance with regulatory requirements. You will establish operational excellence, ensure alignment with company objectives, and drive process improvements to support clinical development goals.

Responsibilities

Strategic Leadership & Oversight

• 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.

Study Management & Execution

• 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.

Team Development and Mentorship

• 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.

Regulatory Compliance & Quality Assurance

• 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. 

Equal Employment Opportunity Statement

T45 Labs and its affiliated companies are Equal Opportunity Employers. We celebrate diversity and are committed to creating an inclusive environment for all employees. Employment decisions are based on qualifications, merit, and business needs.

We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected status.

Required experience and qualifications:

• 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% and work in the Bay Area office at least one day per week.

This position is open to remote candidates; however, preference will be given to applicants located in the San Francisco Bay Area. Candidates based in the Bay Area are generally expected to work in our Santa Clara office at least one day per week to support in-person collaboration and team activities.

T45 Labs and its affiliated companies are committed to fair and equitable pay practices and may also consider additional compensation elements such as bonuses, equity, and benefits as part of the total rewards package.

The anticipated salary range for this position is $197,000 - $267,000 annually, based on San Francisco Bay Area market data. Actual compensation offered may vary depending on factors such as experience, skills, qualifications, and abilities relevant to the role, as well as the geographic location of the individual hired.

Please note that the top of the salary range is reserved for candidates who demonstrate exceptional qualifications and experience directly aligned with the requirements of the role. Most candidates should expect to receive an offer within the mid-range of the posted range, based on these considerations.