Director, Companion Diagnostics

Remix Therapeutics•Watertown, MA

2h•$206,000 - $252,000

About The Position

Remix Therapeutics is a clinical-stage biotechnology company developing small molecule therapies designed to reprogram RNA processing and address disease drivers at their origin. Its REMaster™ technology platform combines data science, biomolecular sciences, and chemistry to identify orally administered compounds that modulate gene expression. The company’s investigational small molecule REM-422 is being evaluated in clinical programs for adenoid cystic carcinoma, acute myeloid leukemia, and high-risk myelodysplastic syndrome. The Director for Companion Diagnostics will drive cross-functional alignment of biomarker operations, clinical development, regulatory and quality expectations with external device and in vitro diagnostic (IVD) partners. The role is responsible for delivering fit-for-purpose devices that meet global regulatory requirements and support clinical decision-making. This individual will partner with cross-functional teams throughout CDx development, IVD clinical validation, and registration, approval, and launch requirements, ensuring high-quality devices and IVDs are available in line with drug-development milestones.

Requirements

Advanced degree in a relevant field, such as molecular biology or biomedical engineering, or equivalent experience.
10+ years of experience in diagnostic development.
4+ years leading CDx or IVD programs in pharmaceutical, medical device, or diagnostic settings.
Proven track record delivering CDx aligned to drug approvals, including successful analytical and clinical validation and device regulatory requirements.
Deep understanding of diagnostic platforms such as NGS, PCR, IHC, software, and DHTs, and their associated verification and validation standards and quality systems.
Experience managing external IVD partners and complex, cross-functional programs.
Awareness of evolving regulatory and quality expectations and ability to translate them into actionable guidance.

Nice To Haves

RAC credential preferred.
Experience in rare disease and oncology indications preferred.

Responsibilities

Align IVD and clinical milestones with IVD quality and regulatory expectations and therapeutic timelines.
Oversee device and IVD partners, ensuring alignment on scopes of work, timelines, budgets, and quality expectations; manage co-development and governance.
Define device and IVD intent, user needs, and target product profiles for CDx platforms, including NGS, PCR, IHC, software, and DHTs, and ensure analytical and clinical performance meets intended use.
Partner with biomarker and clinical teams to integrate IVDs into interventional clinical studies, including screening, enrichment, and stratification, and align sample strategy and operational readiness for device and IVD submissions.
Drive analytical validation plans, including accuracy, precision, sensitivity and specificity, limit of detection, and reproducibility, and clinical validation strategies linking assay results to drug safety and efficacy.
Support global regulatory strategy and submissions with diagnostic and device partners, including FDA PMA, 510(k), EU IVDR, and PMDA submissions, pre-submission interactions, and labeling alignment.
Ensure compliance with applicable device standards and regulations, including ISO 13485, ISO 14971, CLSI guidelines, QMSR, IVDR, and GCP alignment for diagnostic and device use in clinical trials.
Coordinate cross-functional working groups, prepare for audits such as device and IVD BIMO and PAI, remove program obstacles, and provide transparent status updates to governance bodies.
Oversee document review and coordinate recommended edits from cross-functional teams.
Coordinate IVD partner audit preparedness, manufacturing readiness, and supply planning to ensure timely clinical and commercial availability.