Director – Clinical Operations
| Company | PathAI |
|---|---|
| Location | Boston, MA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Master’s, PhD |
| Experience Level | Senior, Expert or higher |
Requirements
- 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.
Responsibilities
- 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.
Preferred Qualifications
- Experience with CDx development is highly desirable.
- Background in histologic-based or other medical imaging in a regulated environment is strongly preferred.