Director, Clinical Operations

PathAI; United States; Remote; USD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking a Director of Clinical Operations to lead innovative clinical trials. In this pivotal role, you will oversee the execution of biopharma and PathAI-sponsored trials, ensuring adherence to regulatory standards and driving organizational growth. You will collaborate with multidisciplinary teams to develop and implement strategies that enhance patient outcomes through cutting-edge technology. If you are a strategic thinker with a passion for improving healthcare through innovation, this opportunity offers a chance to make a significant impact in the field of pathology.

Qualifications

• 8+ years of industry experience with 5+ years in clinical trial execution.
• Strong knowledge of GCP and clinical trial processes.

Responsibilities

• Lead execution of clinical trials and product development strategies.
• Ensure adherence to quality, timelines, and budget for assigned studies.

Skills

Clinical Trial Management

Project Management

Good Clinical Practices (GCP)

Regulatory Submissions

Resource Management

Education

M.S. in Life Science

Ph.D. in Life Science

Tools

SOP Development

Clinical Trial Software

Job description

Who We Are

PathAI is on a mission to improve patient outcomes with AI-powered pathology. We are transforming traditional pathology methods into powerful, new technologies. These innovations in pathology can help accelerate drug development, improve confidence in the accuracy of diagnosis, and get life-saving therapies to patients more quickly. At PathAI, you'll work with a diverse and talented team of people, who are dedicated to solving complex problems and making a huge impact.

Where You Fit

PathAI is seeking a highly experienced, industry-recognized leader as the Director of Clinical Operations to lead clinical trials for biopharma sponsors and PathAI-sponsored LDT and CDx trials. The leader will be accountable for the oversight and execution of multiple biopharma or PathAI-sponsored clinical trials. This role provides strategic and execution oversight to study teams to meet trial goals and timelines while driving organizational growth and development.

The Director of Clinical Operations will oversee the execution of regulated research and clinical products, including companion diagnostic (CDx), non-CDx-IVD, Drug Development Tools (DDT), and pathology biomarker-based clinical trial studies. This highly matrixed, cross-functional role requires outstanding subject matter expertise, communication, and collaboration skills to coordinate programs across various functional areas. These include our GCP-compliant laboratory, quality, regulatory, translational research, algorithm and product development, business development, engineering, and platform teams.

The Director will establish the cultural and operational framework to strengthen collaboration between PathAI teams and sponsor teams to successfully design and execute all aspects of our clinical development programs. Outstanding organizational skills, with a proactive approach to identifying programmatic risks and implementing mitigations, are essential. The individual must have a proven track record of delivering programs with global trial operations deliverables, including experience with regulatory body audits and interactions. Experience with CDx development is highly desirable.

What You’ll Do

• Lead the execution of research and clinical development strategies for clinical trials, research, and Software as a Medical Device product development, and operationalize these strategies from development to commercialization.
• Accountable for the oversight of all assigned studies, ensuring adherence to quality, timelines, and budget in alignment with the overall development plan and clinical operations plan.
• Establish and communicate detailed program and project plans with critical paths and dependencies clearly identified, providing regular updates on timeline progress and risks through defined operating mechanisms.
• Educate relevant leads from each functional area on applicable regulations impacting development programs, emphasizing Good Clinical Practices (GCP) and laboratory standards.
• Drive the development and implementation of GCP-compliant standard operating procedures (SOPs) and processes to support clinical trial execution and ensure adherence to regulatory requirements.
• Lead resource management and forecasting efforts to ensure projects are adequately resourced and efficiently delivered, prioritizing high-impact initiatives.
• Clearly communicate strategy, progress, and risks cross-functionally and proactively facilitate collaboration between internal project teams and external stakeholders.
• Inform leadership of identified gaps, risks, and proposed solutions to ensure alignment and risk mitigation across clinical development programs.

What You Bring

Our employees' skills come in all shapes and sizes, but to be successful in this role with us, you'll at least need:

• M.S. in a Life Science or equivalent field (Ph.D. preferred) and at least 8+ years of relevant industry experience, with a minimum of 5 years in a role with primary responsibility for clinical trial execution and management.
• Strong knowledge of Good Clinical Practices (GCP), clinical trial processes, and laboratory standards, with hands-on experience developing and implementing GCP-compliant SOPs, processes, and tools.
• A comprehensive understanding of drug development (clinical trials, biomarker testing), assay development, and co-development for CDx programs.
• Proven experience in project management, including planning, executing, and delivering complex projects within scope, on time, and on budget.
• Experience with resource management and forecasting to align teams and resources effectively with project priorities.
• Proven experience supporting FDA and other regulatory body submissions, from development to validation to approval.
• Demonstrated success leading multidisciplinary teams of scientists and engineers in a highly matrixed organization.
• Strategic thinker with a proactive, agile mindset and a strong interest in fostering collaboration across internal teams and external partners to deliver innovative treatments to patients.
• Background in histologic-based or other medical imaging in a regulated environment is strongly preferred.

We Want To Hear From You

At PathAI, we are looking for individuals who are team players, are willing to do the work no matter how big or small it may be, and who are passionate about everything they do. If this sounds like you, even if you may not match the job description to a tee, we encourage you to apply. You could be exactly what we're looking for.

PathAI is an equal opportunity employer, dedicated to creating a workplace that is free of harassment and discrimination. We base our employment decisions on business needs, job requirements, and qualifications — that's all. We do not discriminate based on race, gender, religion, health, personal beliefs, age, family or parental status, or any other status. We don't tolerate any kind of discrimination or bias, and we are looking for teammates who feel the same way.

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