Principal Scientist, CDx IHC Development

SystimmuneRedmond, WA

$130,000 - $160,000 / year

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Overview

Schedule

Full-time

Career level

Senior-level

Remote

On-site

Compensation

$130,000-$160,000/year

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Job Description

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success.We are seeking a Principal Scientist to provide technical leadership for the development of immunohistochemistry (IHC) companion diagnostics supporting oncology drug programs. This individual will serve as a subject matter expert responsible for CDx assay strategy, analytical validation, and clinical implementation from early feasibility through regulatory submission and commercialization readiness.The Principal Scientist will lead complex CDx IHC development initiatives, ensure compliance with global regulatory and quality standards, and influence biomarker strategy through deep technical expertise. This is a hands‑on scientific leadership role requiring strong collaboration with pathology, translational science, regulatory, clinical development, and external diagnostic partners to ensure successful CDx execution aligned with therapeutic timelines.This position is full-time onsite at our Redmond, WA location.ResponsibilitiesCDx IHC Kit Development & Strategy

Lead development of IHC-based CDx assays and kits from early feasibility through IVD readiness.
Define assay design, platform selection, and development strategy aligned with CDx regulatory expectations.
Oversee antibody selection, assay optimization, and standardization across platforms (e.g., Ventana, Dako, Leica).
Guide development of scoring algorithms, cut-offs, and interpretation frameworks with pathology leadership.

Analytical Validation & Design Control

Lead analytical validation strategy and execution for CDx IHC assays, including sensitivity, specificity, precision, accuracy, and robustness.
Ensure validation activities meet regulatory expectations and are conducted under design control.
Oversee preparation and approval of validation protocols, reports, and technical documentation.
Ensure traceability, risk management, and documentation in compliance with QSR 820 and ISO 13485.

Clinical & CDx Implementation

Provide oversight for implementation of CDx IHC assays in clinical trials and central laboratories.
Ensure assay consistency, pathologist alignment, and scoring harmonization across sites.
Support biomarker strategy, sample plans, and clinical cut-off justification.

Regulatory & Quality

Partner with Regulatory Affairs and QA to support CDx regulatory strategy and submissions (e.g., IND/IDE, PMA/IVD).
Ensure compliance with global regulatory requirements (FDA, NMPA, IVDR).
Support bridging strategies from RUO/LDT to IVD CDx and contribute to regulatory interactions.
Drive alignment with QMS, including design controls, change control, and audit readiness.

Cross-Functional Leadership

Act as subject matter expert for CDx IHC development across internal and external stakeholders.
Lead collaborations with CROs, central labs, and IVD partners.
Mentor team members and contribute to building CDx development capabilities.

Qualifications

PhD in Pathology, Immunology, Molecular Biology, or related life science field
8–12+ years of industry experience in CDx, IVD, or biomarker assay development
Proven experience leading IHC assay development and analytical validation
Strong knowledge of design controls and QMS (21 CFR Part 820, ISO 13485)
Experience supporting clinical trials and CDx regulatory submissions
Strong understanding of IHC scoring methods (TPS, CPS, H-score)
Experience working in oncology biomarker development environments

Preferred Qualifications

Experience with approved or late-stage CDx programs
Background in oncology biomarkers (e.g., NSCLC, GI cancers)
Experience interacting with health authorities (FDA, NMPA, EU)

Compensation and Benefits:The expected base salary range for this position is $130,000 - $160,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s level qualifications, experience, and skills.While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise exceeds the requirements of the role.SystImmune is a leading and 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.We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.

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FAQs About Principal Scientist, CDx IHC Development Jobs at Systimmune

What is the work location for this position at Systimmune?

This job at Systimmune is located in Redmond, WA, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.

What pay range can candidates expect for this role at Systimmune?

Candidates can expect a pay range of $130,000 and $160,000 per year.

What employment applies to this position at Systimmune?

Systimmune lists this role as a Full-time position.

What experience level is required for this role at Systimmune?

Systimmune is looking for a candidate with "Senior-level" experience level.

What benefits are offered by Systimmune for this role?

Systimmune offers following benefits: Health Insurance, Dental Insurance, Vision Insurance, Disability Insurance, Paid Holidays, Paid Vacation, Paid Sick Leave, 401k Matching/Retirement Savings, and Health & Wellness Programs for this position. Actual benefits may vary depending on the employer's policies and employment terms.

What is the process to apply for this position at Systimmune?

You can apply for this role at Systimmune either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.