Jobs at SystImmune

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.

Lead complex study startup activities for clinical trials, ensuring site activation and compliance with regulatory requirements while mentoring junior specialists.

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.

Support protein engineering and binder discovery using display technologies. Design and generate libraries, perform QC and NGS, culture engineered yeast, construct immune repertoires, run flow cytometry/FACS selection and sorting, troubleshoot and optimize lead molecules, and maintain data integrity in a fast-paced, on-site lab environment.

Lead IT strategy, infrastructure, operations, and cybersecurity for a scaling biotech. Build and manage the IT team and budget, ensure GxP/compliance and CSV, oversee facility IT build-out and transitions, support scientific and enterprise applications (LIMS, ELN, ERP), and manage vendors, incident response, backup, and disaster recovery.

The EDC Programmer designs and maintains clinical trial databases in Medidata Rave, ensuring standards compliance and collaboration with study teams. Key tasks include database design, programming, and managing UAT activities across Phase I-III trials.

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

The Study Startup Specialist coordinates clinical trial initiation by managing document collection, site activation, regulatory submissions, and compliance with guidelines. They ensure timely study start-up across assigned projects and support budget negotiations.

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

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

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

The Head of Quality will manage the pharmaceutical quality management function, ensuring compliance with GMP standards and overseeing quality activities, procedures, and training systems.

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.

The Quality Assurance Manager will ensure compliance with bioanalytical lab QA and CLIA/CAP requirements, develop SOPs, manage audits, and oversee quality metrics.

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