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A leading company at the forefront of pathology AI seeks a Director of Scientific Affairs / Medical Director to advance its research initiatives. Responsibilities include overseeing clinical validation studies, managing laboratory operations, and engaging with BioPharma partners. Candidates should hold MD/DO with board certification in Anatomic Pathology, possess extensive experience in digital pathology, and exhibit strong leadership and communication skills.
About Us: Pictor Labs is at the forefront of innovation in the pathology AI space, delivering cutting-edge virtual staining technologies to enhance the efficiency and precision of histopathology. Our solutions enable pharmaceutical, biotech, and clinical research organizations to unlock deeper insights from tissue samples through advanced, AI driven virtual staining.
Position Overview: The Director of Scientific Affairs / Medical Director will lead Pictor Labs' histopathology research initiatives and play a pivotal role in advancing our regulatory evidence generation, product development, clinical validation efforts, and virtual staining panel development. This individual will serve as a CLIA laboratory director for our anatomic and digital pathology functions. This position leads the laboratory team and serves as the medical authority for tissue procurement, validation studies, and clinical applications of our virtual staining technology and accompanying histotechnology services. The role is an external facing position that interfaces with customers and collaborators about the scientific and laboratory basis of our products.
Key Responsibilities:
Scientific Evidence Generation & Clinical Validation
* Support evidence generation required for regulatory submission and maintenance for US and global agencies
* Design and oversee clinical validation studies with academic, clinical, and industry partners.
* Write and approve manuscripts for peer-reviewed journal submissions / Review claims for marketing related to scientific and clinical aspects of products
Clinical Laboratory Leadership
* Function as laboratory director for CLIA laboratory meeting all requirements and standards of federal, state (e.g. NYSDOH), local, and accreditation agencies.
* Manage laboratory team to ensure completion of all patient needs and business objectives,
Virtual Staining Panel Development
* Direct the scientific development and validation of virtual staining panels across multiple tissue types and applications
* Evaluate concordance between virtual and traditional staining methods and coordinate panels of pathologists to verify this function
* Provide pathological expertise in defining staining parameters and diagnostic criteria.
* Review and approve comprehensive documentation and SOPs for all validated panels.
Tissue Procurement & Management
* Develop and execute strategic plans for tissue acquisition to support development initiatives.
* Oversee system for the management and utilization of tissue blocks and FFPE sections.
* Ensure ethical compliance in all tissue procurement activities.
Leadership & Management
* Collaborate with ML/AI teams to ensure alignment between laboratory and computational initiatives.
* Perform rigorous review of quantitative model performance metrics, including sensitivity, specificity, and concordance rates across different tissue types and clinical scenarios.
* Conduct qualitative assessments of virtual staining outputs, providing expert pathological interpretation of model strengths and limitations in real-world diagnostic contexts.
* Lead multi-disciplinary modeling review sessions integrating pathological expertise with ML/AI technical analyses to optimize virtual staining algorithms for clinical utility.
External Collaboration
* Serve as a medical authority in collaborations with BioPharma partners and academic institutions.
* Represent Pictor Labs in scientific conferences and industry meetings.
* Build relationships with key opinion leaders in digital pathology.
* Participate in educational initiatives to promote virtual staining adoption.
Qualifications:
* MD/DO with board certification in Anatomic Pathology (ABP/AOBP)
* Licensure or ability to obtain and maintain licensure in Utah (or other state designated by company)
* Minimum 1 year experience practicing Anatomy Pathology after completion of training; 5 year preferred.
* Experience in digital pathology or related research environments essential; experience functioning as CLIA director preferred
* Experience with evidence generation required for regulatory submissions and clinical validation studies.
* Strong understanding of tissue pathology across multiple organ systems.
* Experience with Laboratory Information Management Systems (LIMS).
* Knowledge of AI/ML applications in digital pathology preferred.
* Strong organizational, leadership, and project management skills.
* Excellent written and verbal communication skills.
* Publication history in peer-reviewed journals related to pathology or digital imaging.