Reporting to the Vice President of Pathology, You will be responsible for the overall operation and leadership of the Development Pathology Organization. You will lead the Biomaterials Repository, and also directly provide high quality clinical pathology reads or annotation and signing out of Next Generation Sequencing somatic tissue and liquid molecular pathology reports from Genomic Health's Clinical Laboratory.
- Management and oversight of all aspects of the Pathology Development staff to provide the highest quality Pathology professional services for Research and Development efforts ranging from discovery or concept feasibility to product launch and transition to operations.
- Manage Development Pathologists working on internal multi-functional teams and working groups as well as collaborating externally with pathologists, oncologists and surgeons. This position will develop relationships with pathology key opinion leaders.
- Assist in or direct the Pathology Development efforts including writing and review of study concept sheets, study protocols, study letters of intent, and study contracts.
- Develop and mentor employees in developing professional relationships with study collaborators, particularly with collaborator pathologists
- Lead the review of collaborator pathology resources and materials
- Oversee and participate in collection, cleaning and review of study data review including report creation
- Oversee and direct collaborators and/or directly provide H&E slide review for key study covariates
- Define roles and deliverables for team member attendance at key international and domestic medical oncology and pathology meetings
- Direct the submission of pathology abstracts related to the clinical laboratory experience for publication to appropriate meetings which may include: SABCS, ASCO Breast, USCAP, CAP
- Collaborator preparation and personally present pathology related data from relevant Development Product(s) at global conferences and talks.
- Oversee and participate in writing pathology manuscripts related to the commercial process for publication
- Lead or provide subject matter expertise to Accessioning, Customer Service, Medical Affairs and Clinical Pathology teams with launch of new products including: translation, standardisation and documentation of SOPs, definition and development of sample submission criteria and customer materials; handling customer service outreach calls; training staff for customer product queries and scaling of customer related call backs regarding all pathology related questions.
- Train Medical Affairs and Customer Service during new product launch and throughout product life cycle regarding relevant validation results and supporting analyses and data including research and development, and clinical validation.
- Partner with Medical Affairs and Marketing in Speaker Training and Advisory Boards, representing Genomic Health externally.
- Cultivate reputation as leader in Pathology and or Molecular Pathology with documented performance, professional accomplishment and publication history.
- Represent the Clinical Laboratory, Development and Medical Affairs in public speaking engagements on behalf of the company.
- Develop good working relationships with key internal collaborators including: Oncology Development, Product Sciences, Biostatistics, Clinical Operations, Sales and Marketing, Medical Affairs, Process Engineering, Clinical Operations and Clinical Laboratory.
Professional Societies and Meetings
- Participating member of CAP; experience in CAP leadership preferred
- Participating member of AMP preferred
- Attend key pathology and laboratory medicine meetings including: AMP, USCAP & CAP
- Attend key oncology meetings including ASCO, SABCS
Public Speaking and Physician Education
- Work with academic and community anatomic pathologists and staff to extend their understanding of Genomic Health's products
- Participate in Genomic Health Advisory Boards