As a subject matter expert, this role will support the execution and delivery of clinical and translational biomarker services for Sponsor and internal R&D studies. This role will function to lead and support immunostaining assay development, biomarker projects, and advanced image analysis including developing and applying AI-driven image analysis algorithms to quantitatively assess histopathology and biomarker data, while also serving as a scientific partner to clients from study design through data interpretation and presentation.
The role will work cross-functionally with pathologists, laboratory technicians, scientists, project operations and business development teams, and will directly support pharmaceutical and biotechnology clients in planning, executing, and interpreting biomarker studies across preclinical and clinical programs.
Responsibilities
What you'll be doing:
Lead/Support Scientific Efforts for Computational and Digital Pathology:
Act as a scientific interface with clients, participating in client meetings, protocol reviews and data review meetings
Provide expert input on design and conduct of clinical or translational studies incorporating biomarker endpoints and “omics and non-omics” techniques including but not limited to immunostaining, proteomics, spatial biology, computational and digital pathology.
Prepare and/or support the preparation and review of project plans, analysis plans and study reports, abstracts, manuscripts, and technical reports.
Perform and/or support the analysis and interpretation of biomarker data including providing clear, scientifically rigorous data visualizations, analyses, and summaries.
Assay Development, Image Analysis and Algorithm Development:
Partner with laboratory technicians to support immunostaining assay development, optimization, and validation.
Define analytical endpoints, scoring strategies, and quality control metrics aligned with assay performance.
Contribute to assay validation documentation and analytical reports as required.
Develop, validate, and maintain image analysis pipelines for immunostaining (IHC), immunofluorescence (IF), in situ hybridization (ISH), and multiplex assays.
Design and implement AI/machine learning algorithms for tissue segmentation, cell characterization, and biomarker quantification.
Collaborate with pathologists through end-to-end workflows including assay development, validation, quantitative read-outs and interpretation.
Ensure traceability, reproducibility, and documentation of analysis workflows.
Business Development Support:
Assist with business development activities including participating in client meetings, requests for proposal (RFP) responses, project pricing, protocol review, and bid defenses as needed.
Provide advice to sponsors seeking guidance
Assist in the development of sales, marketing and promotional materials as needed.
Product and Service Innovation Support:
Contribute to continuous improvement of computational, digital pathology, spatial biology and translational research capabilities.
Assist in the development of our product/service platforms to ensure all stakeholder requirements are being considered, documented, and translated to the final solution.
Participate in brainstorming meetings and functionality reviews.
Qualifications
Post-graduate degree / professional designation; 7-9 years related experience, plus continuous training and knowledge/skills upgrading
Strong experience with digital pathology and image analysis
Solid understanding of histopathology and immunostaining techniques
Experience working in CRO, laboratory, biopharma and/or regulated research environment, ideally supporting clinical and translational research studies
Experience presenting data to external stakeholders or at scientific meetings
Scientific rigor and attention to detail - able to communicate complex scientific concepts and results clearly to all stakeholders
Strong written and oral English communication skills, problem-solving and analytical thinking
Ability to manage multiple projects in fast-paced environment with a collaborative mindset across disciplines
Compensation is dependent on the unique experience, skills, and education the successful candidate brings to the role. The range above represents an estimated base salary that we would expect to compensate at, but we encourage applicants to speak with the member of the TA team if contacted for an initial phone screen should your expectations differ from those listed above.
