Senior Director, Clinical Operations
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 Senior Director Clinical Operations to lead clinical trials for biopharma sponsors and PathAI sponsored LDT and CDxl trials. The leader will be accountable for the oversight and execution of multiple biopharma or PathAI sponsored clinical trials. The role will provide strategic and execution oversight to study teams to meet trial goals and timelines. The role will also help establish and deliver goals towards growth of the organization and the team.
The leader of clinical operations will lead 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 is a highly matrixed cross functional role that requires outstanding subject matter expertise, communication and collaboration skills to help coordinate the program across all functional areas including our GCP lab, quality, regulatory, translational research, algorithm and product development, business development, engineering and platform teams. The Senior Director of Clinical Operations will establish the cultural and operational framework to strengthen collaboration between PathAI teams and sponsor team to successfully design, execute on all aspects of our clinical development programs. Outstanding detailed organizational skills with a proactive mindset toward identification of all programmatic risks and mitigations is essential. The individual must have an established track record of delivering programs with global trial operations deliverables including experience with regulatory body audits and interactions. Experience with CDx development will be highly desirable.
What You’ll Do
- Lead the execution of research and clinical development strategies for new clinical trial, research, and medical device product development, and operationalize these strategies from development to commercialization.
- Accountable for oversight of all assigned studies within the country in accordance with the overall development plan and clinical operations plan, including adherence to quality, timelines and budget.
- Establish and continually communicate detailed program and project plans with critical paths and dependencies clearly identified across each area and communicate timeline progress and risks through defined operating mechanisms.
- Educate relevant leads from each functional area on the regulations impacting development programs.
- Clearly communicate strategy, progress, and risks cross functionally and proactively drive/facilitate the relationship between internal project teams and external stakeholders.
- Effectively prioritize the projects within our clinical development programs to ensure adequate resourcing and efficient delivery on priority projects for PathAI.
- Inform leadership of any identified gaps, risks, solutions to the program as a whole.
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:
- Ph.D (preferred) or M.S. in a Life Science or equivalent field, plus at least 7-10 years of relevant industry experience, including at least 5 years in a role of primary responsibility for clinical trial execution and management.
- You have a solid understanding of and experience in drug development (clinical trials, biomarker testing), assay development, and co-development for CDx programs.
- Direct management experience and supervisory responsibility.
- You have knowledge (training preferred) of the software development life cycle (IEC 62304), design control, and experience in leading in vitro diagnostic development teams.
- You have supported projects for FDA and other regulatory body submissions from development to validation to approval.
- You excel in leading multidisciplinary teams of scientists and engineers in highly matrixed organization is strongly preferred
- You are a strategic thinker, pro-active and agile, and you have a strong interest in bringing teams together at PathAI, as well as external partners, to bring better treatments to patients.
- Experience 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.