Associate Director / Director, Regulatory Affairs – IHC Companion Diagnostics (CDx)
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Overview
Schedule
Full-time
Career level
Director
Compensation
$150,000-$230,000/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 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 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
- 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
- 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
- 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
- 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
- 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 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 Associate Director / Director, Regulatory Affairs – IHC Companion Diagnostics (CDx) 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 $150,000 and $230,000 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 "Director" experience level.
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.