Clinical Pathology Scientist (Principal Scientist)

The Clinical Pathology Scientist (Principal Scientist) supports clinical teams in the use of pathology in clinical trials, ensuring timelines and deliverables are met and of high quality. The CPS also leads operational and scientific initiatives to improve the effectiveness of one or more aspects of our development programs. This position will work closely with the Head of Clinical Imaging and Pathology, Pathology Leads, and other Clinical Pathology and Imaging Scientists to provide support internally and externally, as follows:
Provide day-to-day oversight of key pathology deliverables on trials.
Interface with internal stakeholders and external collaborators (such as pathology service vendors) to ensure seamless execution and support for the pathology component of clinical trials.
Become an expert in at least one group of disease indications, supporting internal and external teams, applying efficiencies and standards developed while supporting the portfolio.
Execute and manage existing pathology strategies for early and late-stage clinical trial support.
Exercise foresight and judgment in planning, organizing, and guiding complex pathology projects.
Work across departments to advance pathology processes, and as needed, challenge the status quo to foster innovation.
Provide recommendations to enhance technologic pathology strategies and support systems
Work with quality and compliance teams for quality-related decision making internally, and to support audits of pathology service providers
Apply understanding of regulatory requirements to support questions related to filings and regulatory strategy related to pathology.
Support industry presence for our company in clinical pathology at national meetings
Support internal initiatives and collaborations with a focus on process improvement, identifying solutions and recommending a course of action.

Quals--
Required Experience and Skills:
Education Minimum Requirement: Bachelor s degree required
At least 10 years of experience supporting clinical development in industry.
Knowledge of the use of pathology in clinical trials for evaluation of efficacy and safety
Skill in authoring clinical pathology operations documents for trials using pathology for evaluation of efficacy and safety.
Regulatory experience supporting drug filings

Preferred/Nice to have Experience and Skills:
Histotechnologist certification or Anatomic Pathology Assistant certification.
Experience working at, or working closely with, anatomic pathology core laboratories.
Experience collaborating with colleagues in cross-functional groups.
PMP certification

Note:-
100% remote role.
Candidates within EST/CST zone preferred.
No travel required

Key Skills:-
One of the primary requisites for this role would be experience working in a central lab space either as a Project manager and have supported oncology/ immunology studies, or worked in clinical trial setting supporting oncology/ immunology studies with tissue based testing.
1. Experience working in a CRO lab or in a clinical trial setting as a PM or Clinical scientist and study manager
2. Central labs expertise/settings
3. Central labs experience
4. Preferable TA- oncology
5. Managed tissue samples and tissue testing