Jobs at KMR Search Group

Lead and mentor scientists to design, validate, and transfer NGS assays and workflows for a novel sequencing platform. Perform hands-on molecular biology experiments, generate technical instrument requirements, analyze/interpret data, document results in ELNs, and collaborate with cross-functional teams to support development, verification/validation, and commercialization of clinical NGS applications.

Lead technical strategy and operations for bioinformatics assay development and CLIA/IVD clinical diagnostics. Oversee algorithm and data analysis across development and production, establish CLIA bioinformatics procedures, partner cross-functionally, and mentor bioinformatics data scientists/engineers.

Lead global regulatory and quality assurance strategy for a clinical-stage pharmaceutical company. Oversee FDA and international submissions, manage QA systems (SOPs, CAPA, document control, training), advise senior leadership on regulatory risk, and direct cross‑functional regulatory and quality activities to ensure compliance and timely approvals.

Lead regulatory strategy and submissions (primarily CMC, also clinical and non-clinical) for investigational and marketed products. Serve as RA lead on cross-functional teams, liaise with FDA and other health authorities, drive regulatory due diligence, and implement policies to ensure timely approvals and compliance with ICH, FDA, and EU guidelines.

Lead global clinical regulatory activities including strategy and operations for IND/CTA and BLA submissions, liaison with FDA and other health authorities, and support clinical and marketing objectives to ensure compliance and timely approvals.

Lead facility engineering, construction project management, HSE and environmental compliance across pharmaceutical sites. Ensure GMP metrology, maintenance harmonization, emergency response, permitting, budgets, performance metrics, and staff development to maintain compliant, safe cleanroom and warehouse operations.

Provide global pharmacovigilance and safety leadership for immunology/inflammation products, including signal detection, risk/benefit assessment, safety strategy, regulatory submissions, cross-functional team leadership, and preparation of periodic safety reports and labeling input.

Lead global CMC regulatory strategy and preparation of eCTD submissions for investigational and commercial biologics. Provide regulatory guidance to project teams, interact with health authorities, monitor evolving CMC regulations, and manage a team of Regulatory Affairs directors and managers.