Angitia Biopharmaceuticals

Accountant

• Perform month-end and quarter-end close activities, including journal entries, accruals, and reconciliations.
• Prepare supporting schedules for financial statements and audits in accordance with US GAAP.
• Manage accounts payable and Procure-to-Pay (P2P) processes, ensuring timely invoice processing and compliance.
• Oversee procurement accounting, including PO management and resolving discrepancies.
• Maintain and reconcile fixed asset records.
• Support payroll and equity processing, including reports, journal entries, and payroll and equity reconciliations.
• Support R&D expense accruals and project cost tracking.
• Assist with NetSuite ERP workflows and internal controls.
• Prepare variance analysis and provide insights for management reporting.
• Provide audit support by fulfilling PBC requests, organizing supporting documentation, and responding promptly to auditor inquiries.
• Drive process improvements to streamline accounting operations.
• Support IPO readiness through SEC-compliant reporting, SOX controls, audit coordination, equity schedules, and public company reporting processes.

Senior Accountant

Director

• Serve as lead statistician on project teams, providing strategic and operational expertise for all stages of clinical development programs and support of other functions
• Write or review protocols, SAP, CSR and other related documents to ensure scientific integrity of the applied statistical methodology
• Adhere to company standards, and all applicable regulations and guidelines
• Perform or oversee statistical analyses and interpretation of study results. Direct vendors to perform all statistical related tasks
• Collaborate cross-functionally on study design, data standards, and reporting
• Supply statistical input for regulatory submissions and in response to agency queries.
• Collaborate on interdepartmental and scientific activities
• Provide support for investigator publications
• Ensure compliance with departmental and company goals
• Effectively communicates timely and relevant updates to all team members involved
• Oversee the work of junior(s) including mentoring of staff on all assigned clinical studies

Director, Biostatistics

QA Engineer

• Drive and cultivate a culture of quality throughout the company to help ensure compliance with all applicable regulations, guidelines, and corporate standards, policies, and procedures.
• Provide QA oversight and support to internal staff in support of Angitia sponsored clinical studies and GLP studies.
• Development and management of processes and controlled documents related to Angitia sponsored clinical studies (clinical operations, clinical development, pharmacovigilance, regulatory) and GLP studies (translational medicine).
• Prepare for health authority audit readiness.
• Develop phase-appropriate Clinical QA operating models in accordance with ICH risk-based compliance guidance; set a strong foundation for future commercial operations.
• Develop and implement audit plans and schedule for clinical study vendors and other study related GxP vendors (CROs, central /specialty labs, imaging, etc.).
• Oversee and/or perform site and vendor audits to assure quality assurance compliance with regards to all internal as well as applicable regulatory guidelines.
• Lead selection of contract auditors to perform site and vendor audits as needed.
• Ensure timely and effective follow up to all identified or assigned quality issues.
• Conduct QA review of Angitia sponsored clinical study documents, internal controlled documents and vendor documents.
• Train internal staff on regulatory requirements such as GCP training.
• Ensure training compliance and completion for Clinical Development, and potentially others.
• Identify critical compliance and/or business issues related to GxP, CROs, Contract Test Laboratories and manufacturers of critical starting materials. Create and execute remediation strategies and tactical plans as needed using a risk-based approach.
• Develop and oversee study quality metrics for clinical studies including study risk assessment, mitigation and CAPA management.
• Coordinate and host all FDA and Health Authority inspections.
• Ensure all Quality agreements are effectively negotiated to meet the near- and long-term needs of Angitia as agreed with legal, finance and functional heads.
• May require up to 25% travel.

Director, Clinical Quality Assurance

Vice President

• Lead all GxP Quality functions, including Quality Assurance, Quality Control, R&D Quality, Document Control, Supplier Quality, and Quality Systems.
• Define and drive the company’s quality vision, ensuring compliance across global operations and supporting programs from early development through commercialization.
• Shape and execute the path from pre-IND through commercialization by developing and implementing phase-appropriate Quality models aligned with ICH risk-based guidance.
• Build and optimize scalable Quality Systems to support effective, compliant operations.
• Oversee quality oversight of CDMOs, CROs, contract labs, and critical material suppliers; identify risks and lead remediation using a risk-based approach.
• Partner with external Quality teams to ensure uninterrupted supply and support current and future production plans.
• Lead and resolve major deviation investigations to safeguard product quality, safety, and efficacy.
• Manage Quality metrics, monitor compliance trends, and implement mitigation plans as needed.
• Support global regulatory submissions (IND, NDA, BLA) in partnership with Regulatory Affairs and lead company-wide readiness and execution for regulatory inspections.
• Lead and host all FDA and Health Authority inspections and facilitate Quality related continuous improvement initiatives
• Oversee Quality Agreement negotiations and manage budget, capital planning, and cost optimization.

Vice President, Head of Quality

• Serve as BABM expert on cross-functional drug development teams and lead BABM related program(s) and activities
• Lead internal process and procedure setup and develop corresponding SOPs
• Lead and manage BABM data interpretation, and reporting; present bioanalytical results and update BA status to study teams
• Interface with internal study and clinical teams to define and execute BABM strategies
• Write and review relevant sections of study protocols, analysis plans (assay development and validation plans, sample analysis plan), reports (validation report, sample analysis report), Investigator Brochures, documents for IND filings and NDA/BLA submissions
• Select and manage BABM CROs conducting regulated (e.g. GLP, GCP) and non-regulated PK, immunogenicity (ADA and NAb), and Biomarker sample analysis
• Monitor BABM CROs process and procedures to ensure their work qualities

Senior Accountant

Director, Biostatistics

Director, Clinical Quality Assurance

Vice President, Head of Quality

Senior Manager / Associate Director, Bioanalytical and Biomarker Sciences