Senior scientist, Clinic Pathology and CDx - Redmond, United States - SystImmune

Description

Located in Redmond WA, Systimmune Inc. is a clinical-stage bio-pharmaceutical company focused on the treatment of cancer through developing breakthrough-therapeutic multi-specific antibodies, as well as antibody-drug conjugates (ADCs). Currently, the company has eight assets in ongoing clinical trials and a robust preclinical pipeline of therapeutics from discovery through IND-enabling stage.

Job Summary:

Systimmnue's Clinic Pathology and Companion Diagnostics Business (CDx) to develop, manufacture and commercialize in vitro diagnostic devices, which are a critical part of precision medicine. We are looking for a talented and dedicated biologist to join our Clinic Pathology, CDx Research and Development team. You will define the clinical requirements for new diagnostic products, lead the clinical biomarker development and validation strategy to register these products as In Vitro Diagnostics with regulatory agencies, drive medical value innovation and clinical differentiation of key products, and contribute to driving exploratory research towards novel product opportunities including digital clinical decision support. You join our Clinic Pathology and CDx team, focusing on patient sample analysis using immunohistochemistry (IHC) techniques. The successful candidate will be responsible for conducting experiments, analyzing data, and contributing to the overall success of our clinical trial programs. This position requires expertise in IHC methodologies, as well as experience working in CLIA-certified laboratory environments. You will work in a cross-functional team dedicated to the design and development of CDx assays in a highly regulated environment. This position based on Redmond WA with onsite work locations. The position will report to the Sr Director of Clinical Pathology and CDx Lab. Specific responsibilities serving as a Clinical Development Lead at the Sr Scientist level.

Key Responsibilities:

1. Lead the design and development of IHC-based companion diagnostic assays to detect and quantify biomarkers for patient stratification and treatment response monitoring. Perform immunohistochemistry experiments on patient samples collected from clinical trials.
2. Lead feasibility assessments and assay optimization studies to select and validate biomarkers for inclusion in IHC-based companion diagnostic assays. Conduct data analysis and interpretation, including quantification of IHC staining and correlation with clinical outcomes.
3. Establish and validate analytical performance characteristics of IHC assays, including sensitivity, specificity, reproducibility, and robustness, in accordance with regulatory guidelines (FDA, EMA).
4. Maintain accurate records of experimental procedures, results, and data analysis in compliance with regulatory requirements.
5. Collaborate with cross-functional teams, including research, clinical development, biostatistics, and regulatory affairs, to define biomarker strategies and integrate companion diagnostics into clinical trial protocols.
6. Generate technical documentation, including assay protocols, SOPs, validation reports, and regulatory submissions, to support companion diagnostic development and regulatory approval.
7. Implement quality control procedures and participate in laboratory inspections and audits to ensure compliance with regulatory standards (ISO13485, CLIA and CAP).
8. Stay current with scientific literature and emerging technologies in the field of immunohistochemistry and clinical trial research and advancements in IHC technologies, biomarker discovery, and regulatory requirements for companion diagnostics, and integrate new methodologies into development strategies.
9. Drive the execution of the global clinical diagnostic strategy for therapeutic programs in early and late-stage clinical development.

Qualifications:

1. Ph.D. or M.S. in Biological Sciences, Pathology, Immunology or related field with a minimum of 4 years (Ph.D.) and 7 years (MS) of relevant experience in clinical research or diagnostic laboratory settings.
2. Demonstrated expertise in immunohistochemistry techniques, including tissue processing, antigen retrieval, antibody staining, and imaging analysis.
3. Experience working in CLIA-certified laboratories and familiarity with CLIA regulations and quality control standards.
4. Strong analytical skills with the ability to interpret complex experimental data and draw meaningful conclusions.
5. Excellent organizational skills and attention to detail, with the ability to manage multiple projects simultaneously.
6. Effective communication and interpersonal skills, with the ability to work collaboratively in a team environment.
7. Proficiency in relevant software tools for data analysis and image quantification (e.g., ImageJ, HALO).
8. Prior experience with biomarker discovery or companion diagnostics development is desirable.
9. Passionate about working at the intersection of digital pathology and AI. The ideal candidate will have a strong interest in leveraging cutting-edge technology to revolutionize pathology practices and contribute to the advancement of healthcare. Experience or knowledge in digital pathology, image analysis, machine learning, and related fields is highly desirable.

SystImmune is a stable, well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.