Associate Director / Director, Regulatory Affairs – IHC Companion Diagnostics (C
SystImmune Inc., Redmond, Washington, United States, 98052
Overview
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 platforms for 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, and a robust preclinical pipeline in discovery and IND-enabling stages. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. We are seeking a Regulatory Affairs leader at the Associate Director or Director level to lead IHC-based Companion Diagnostics (CDx) regulatory strategy and execution in support of our oncology ADC pipeline. This role will serve as the regulatory authority for CDx programs, with direct FDA CDRH engagement, and will build and lead a growing CDx Regulatory team over time. The successful candidate will set regulatory direction, guide cross-functional teams, and ensure high-quality IDE and PMA submissions, while remaining hands-on to provide technical oversight and mentorship when needed. This position reports directly to the Head of CDx and is a core leadership role in the CDx organization. Key Responsibilities
CDx Regulatory Leadership
Lead US regulatory strategy for IHC-based Companion Diagnostics across multiple oncology programs Serve as the regulatory decision-maker for CDx development, submissions, and FDA engagement Establish CDx regulatory best practices, processes, and governance within the organization
FDA CDRH Engagement & Representation
Act as the senior regulatory representative to FDA CDRH for IHC CDx programs Lead FDA Pre-Submission (Q-sub), IDE, and PMA interactions at a strategic and executional level Guide preparation of FDA briefing packages and responses, ensuring scientific and regulatory consistency
Team Building & People Leadership
Build, mentor, and lead a CDx Regulatory Affairs team, with direct reports added over time Set expectations, review work quality, and develop regulatory talent within the CDx organization Provide regulatory leadership and mentorship to cross-functional partners and junior team members
Cross-Functional & External Leadership
Partner with Drug Regulatory (CDER), Clinical Development, Biomarker, Pathology, and QA leaders to ensure aligned drug–diagnostic co-development Lead regulatory coordination with external diagnostic partners, CROs, and central laboratories Represent CDx Regulatory perspectives in senior cross-functional and program governance meetings
Submission Oversight & Quality
Provide leadership oversight for IDE, PMA, and PMA supplement submissions for IHC CDx Ensure analytical and clinical performance strategies (including scoring and cutoff rationale) meet FDA expectations Maintain high regulatory quality standards while enabling efficient execution
Risk Management & Readiness
Identify and proactively manage regulatory risks related to IHC assay performance, interpretation, and transfer Support inspection readiness and regulatory compliance for CDx partners and internal processes Monitor evolving FDA CDx and IHC-related guidance and assess impact on portfolio strategy
Qualifications
Bachelor’s degree or higher in Life Sciences, Pathology, Molecular Biology, or related field 8+ years (Associate Director) or 10+ years (Director) of regulatory affairs experience in IVD/CDx Demonstrated experience leading FDA CDRH interactions for Companion Diagnostics Strong background in IHC-based CDx development, including understanding of scoring systems and clinical cutoffs Proven ability to lead cross-functional teams and influence without authority Preferred
Prior experience managing or building regulatory teams Oncology CDx experience supporting patient selection strategies Experience working with automated IHC platforms and external diagnostic partners Familiarity with global CDx regulations (EU IVDR, China NMPA) Leadership Competencies
Strategic decision-making with execution awareness Clear, confident FDA-facing communication Ability to develop people and build scalable regulatory functions Strong judgment balancing regulatory rigor with program timelines Compensation and Benefits
The expected base salary range for this position is $150,000 - $230,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s 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 offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of 5 years, 15 PTO days per year, sick leave, 11 paid holidays, and more. We are an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.
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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 platforms for 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, and a robust preclinical pipeline in discovery and IND-enabling stages. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. We are seeking a Regulatory Affairs leader at the Associate Director or Director level to lead IHC-based Companion Diagnostics (CDx) regulatory strategy and execution in support of our oncology ADC pipeline. This role will serve as the regulatory authority for CDx programs, with direct FDA CDRH engagement, and will build and lead a growing CDx Regulatory team over time. The successful candidate will set regulatory direction, guide cross-functional teams, and ensure high-quality IDE and PMA submissions, while remaining hands-on to provide technical oversight and mentorship when needed. This position reports directly to the Head of CDx and is a core leadership role in the CDx organization. Key Responsibilities
CDx Regulatory Leadership
Lead US regulatory strategy for IHC-based Companion Diagnostics across multiple oncology programs Serve as the regulatory decision-maker for CDx development, submissions, and FDA engagement Establish CDx regulatory best practices, processes, and governance within the organization
FDA CDRH Engagement & Representation
Act as the senior regulatory representative to FDA CDRH for IHC CDx programs Lead FDA Pre-Submission (Q-sub), IDE, and PMA interactions at a strategic and executional level Guide preparation of FDA briefing packages and responses, ensuring scientific and regulatory consistency
Team Building & People Leadership
Build, mentor, and lead a CDx Regulatory Affairs team, with direct reports added over time Set expectations, review work quality, and develop regulatory talent within the CDx organization Provide regulatory leadership and mentorship to cross-functional partners and junior team members
Cross-Functional & External Leadership
Partner with Drug Regulatory (CDER), Clinical Development, Biomarker, Pathology, and QA leaders to ensure aligned drug–diagnostic co-development Lead regulatory coordination with external diagnostic partners, CROs, and central laboratories Represent CDx Regulatory perspectives in senior cross-functional and program governance meetings
Submission Oversight & Quality
Provide leadership oversight for IDE, PMA, and PMA supplement submissions for IHC CDx Ensure analytical and clinical performance strategies (including scoring and cutoff rationale) meet FDA expectations Maintain high regulatory quality standards while enabling efficient execution
Risk Management & Readiness
Identify and proactively manage regulatory risks related to IHC assay performance, interpretation, and transfer Support inspection readiness and regulatory compliance for CDx partners and internal processes Monitor evolving FDA CDx and IHC-related guidance and assess impact on portfolio strategy
Qualifications
Bachelor’s degree or higher in Life Sciences, Pathology, Molecular Biology, or related field 8+ years (Associate Director) or 10+ years (Director) of regulatory affairs experience in IVD/CDx Demonstrated experience leading FDA CDRH interactions for Companion Diagnostics Strong background in IHC-based CDx development, including understanding of scoring systems and clinical cutoffs Proven ability to lead cross-functional teams and influence without authority Preferred
Prior experience managing or building regulatory teams Oncology CDx experience supporting patient selection strategies Experience working with automated IHC platforms and external diagnostic partners Familiarity with global CDx regulations (EU IVDR, China NMPA) Leadership Competencies
Strategic decision-making with execution awareness Clear, confident FDA-facing communication Ability to develop people and build scalable regulatory functions Strong judgment balancing regulatory rigor with program timelines Compensation and Benefits
The expected base salary range for this position is $150,000 - $230,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s 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 offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of 5 years, 15 PTO days per year, sick leave, 11 paid holidays, and more. We are an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.
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