Jobs at SystImmune

Lead statistical programming across complex clinical development programs, overseeing datasets, tables, listings, graphs, regulatory submissions, programming teams, and external vendors. Develop and review programming plans, validation procedures, and regulatory deliverables; support biostatistics and cross-functional study teams; maintain SOPs and archives; estimate project resources; and ensure high-quality, timely outputs for FDA, EMA, NMPA, PMDA, and other agencies.

The PV Operations Specialist oversees pharmacovigilance operations, including safety case processing, regulatory submissions, and maintaining data integrity while collaborating with internal and external stakeholders.

The role involves designing and developing novel assays, proteins, and data analysis for biologics drug development, with responsibilities in functional screening and optimization of biologics leads.

The Director of Protein Engineering will lead the FUSE team, managing scientists and advancing yeast display platforms, ensuring effective drug discovery for cancer treatments.

As VP of Business Development, you'll drive growth by developing strategies, identifying partnerships, managing collaborations, and leading negotiations to enhance clinical assets promotion.

Lead the development of immunohistochemistry CDx assays, oversee analytical validation, and ensure regulatory compliance within oncology drug programs.

Supports downstream protein purification, characterization, and process development for biopharmaceutical molecules. Performs chromatography, tangential flow filtration, viral clearance, filtration, analytical assays, and low-endotoxin production runs. Uses ÄKTA systems and biophysical instruments, analyzes and reports data, authors SOPs, supports tech transfer to GMP manufacturing, and contributes to process scale-up, scale-down, and timeline planning. The role is full-time onsite and may occasionally require work outside normal hours.

Leads the Protein Sciences function and team supporting oncology biologics discovery through IND-enabling activities. Oversees mammalian protein expression, purification, engineering, and biochemical and biophysical characterization of complex biologics. Establishes scalable, automated workflows, ensures reagent quality and reproducibility, advances candidate molecules, and partners with Protein Engineering, Antibody Discovery, Analytical Sciences, and external organizations. Provides scientific strategy, risk assessment, people leadership, and cross-functional support for antibody, bispecific, multispecific, and ADC programs.

Lead cross-functional planning and execution for oncology biologics programs from discovery through IND-enabling and submission. Build and drive integrated project plans, manage risks and dependencies, facilitate governance and meetings, coordinate external partners/CROs, support budget/resource tracking, and produce executive-ready communications and program metrics.

Lead business development efforts in China, establishing partnerships, conducting market analysis, and coordinating with global teams to drive oncology innovations.

Support clinical and non-clinical studies by cleaning, visualizing, analyzing, and reporting data. Develop and validate statistical programs (SAS, R, Python), generate TLFs, conduct interim and PK analyses, write/review SAPs, SARs, and CSRs, oversee CRO programming, ensure CDISC-compliant SDTM/ADaM outputs, perform simulations and QC, and apply regulatory statistical standards.

Hands-on lab role to engineer stable mammalian cell lines (lentiviral transduction, CRISPR knock-ins/outs), run and optimize cell-based immunoassays (flow cytometry, ELISA, Incucyte), perform reagent and cell line qualification, analyze datasets, and present technical reports to support immuno-oncology drug discovery and development.

The Executive Director, Finance leads financial strategy supporting clinical programs, managing budgets, vendor relationships, and team leadership within the biotech sector.

This Human Resources Intern role involves coordinating interviews, supporting full-cycle recruiting and HR operations, and assisting with process improvement projects.

Lead Analytical teams and strategy, oversee method development and validation for biologics, ensuring compliance and successful technology transfer between sites.

The HR Business Partner will support various teams by providing HR guidance on performance management, employee relations, recruiting, and organizational effectiveness, while ensuring compliance with laws and policies.

Lead establishment and continuous improvement of a GMP-compliant Quality Management System for IHC-based companion diagnostics (CDx). Oversee transition from RUO/LDT to regulated IVD CDx, design control, ISO 14971 risk management, document control, supplier quality, CAPA and change control. Serve as management representative and primary interface for FDA inspections, audits, and regulatory interactions. Build and mentor a QMS team and drive inspection readiness and regulatory submissions.

Support statistical programming for clinical trials by creating and validating SDTM/ADaM datasets, developing and validating TFLs, and producing Define.xml and reviewer guides. Collaborate with biostatisticians and cross-functional teams, review study documents, develop SAS programs and macros, and ensure outputs meet CDISC standards, regulatory requirements, and SOPs.

Lead CDx IHC development, managing technical strategy, team development, and regulatory compliance for oncology drug programs in a hands-on role.