Job Title

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 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 sufficiently 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 LeadershipLead US regulatory strategy for IHC-based Companion Diagnostics across multiple oncology programsServe as the regulatory decision-maker for CDx development, submissions, and FDA engagementEstablish CDx regulatory best practices, processes, and governance within the organizationFDA CDRH Engagement & RepresentationAct as the senior regulatory representative to FDA CDRH for IHC CDx programsLead FDA Pre-Submission (Q-sub), IDE, and PMA interactions at a strategic and executional levelGuide preparation of FDA briefing packages and responses, ensuring scientific and regulatory consistencyTeam Building & People LeadershipBuild, mentor, and lead a CDx Regulatory Affairs team, with direct reports added over timeSet expectations, review work quality, and develop regulatory talent within the CDx organizationProvide regulatory leadership and mentorship to cross-functional partners and junior team membersCross-Functional & External LeadershipPartner with Drug Regulatory (CDER), Clinical Development, Biomarker, Pathology, and QA leaders to ensure aligned drug-diagnostic co-developmentLead regulatory coordination with external diagnostic partners, CROs, and central laboratoriesRepresent CDx Regulatory perspectives in senior cross-functional and program governance meetingsSubmission Oversight & QualityProvide leadership oversight for IDE, PMA, and PMA supplement submissions for IHC CDxEnsure analytical and clinical performance strategies (including scoring and cutoff rationale) meet FDA expectationsMaintain high regulatory quality standards while enabling efficient executionRisk Management & ReadinessIdentify and proactively manage regulatory risks related to IHC assay performance, interpretation, and transferSupport inspection readiness and regulatory compliance for CDx partners and internal processesMonitor evolving FDA CDx and IHC-related guidance and assess impact on portfolio strategyQualificationsBachelor's degree or higher in Life Sciences, Pathology, Molecular Biology, or related field8+ years (Associate Director) or 10+ years (Director) of regulatory affairs experience in IVD/CDxDemonstrated experience leading FDA CDRH interactions for Companion DiagnosticsStrong background in IHC-based CDx development, including understanding of scoring systems and clinical cutoffsProven ability to lead cross-functional teams and influence without authorityPreferredPrior experience managing or building regulatory teamsOncology CDx experience supporting patient selection strategiesExperience working with automated IHC platforms and external diagnostic partnersFamiliarity with global CDx regulations (EU IVDR, China NMPA)Leadership CompetenciesStrategic decision-making with execution awarenessClear, confident FDA-facing communicationAbility to develop people and build scalable regulatory functionsStrong judgment balancing regulatory rigor with program timelinesCompensation 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 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.