OrganOx

Financial Planning and Analysis

• **ABOUT ORGANOX:**
• OrganOx is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. The company was established as a spin out of the University of Oxford in 2008 and is now part of the Terumo Group. OrganOx is a pioneer in normothermic machine perfusion (NMP). It's flagship platform, the metra®, is available for use in the U.S., Europe, Canada, and Australia. It has been utilized in over 7,000 liver transplants to date to keep donor livers in a metabolically active state outside the body enabling longer preservation times and functional assessment of the organ prior to transplant, leading to an increased number of organs available for transplant. Founded in 1921, Terumo Corporation (TSE:4543) strives to fulfill its mission of “Contributing to Society through Healthcare” by providing a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions.
• Position Summary
• The Financial Planning and Analysis Manager is responsible for providing hands on leadership, coordination, and planning to execute financial planning processes and ensure the timeliness, accuracy, and integrity of financial information in support of the Global Commercial, Marketing and Operations organization. This role is also responsible for preparing financial forecast and analytics to enable informed decision-making by executive staff and presentation of financial performance summaries shared with senior leaders. Ability to work collaboratively across multiple functions located in various global locations is critical.
• Listed below are the major responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally exhaustive.
• This is a hybrid position in Maddison, NJ.
• Major Responsibilities
• Under direction from the VP of Finance, the Financial Planning and Analysis Manager will be responsible for:
• · Lead the global commercial, marketing and operations quarterly FP&A planning and forecasting process by ensuring timely review and approval of business assumptions with key stakeholders to build detailed projection models and translate them into P&L expectations.
• · Work closely with commercial team to forecast and report on revenue and partner with supply chain to ensure alignment on supply forecast meet demand forecast (Integrated Business Planning).
• · Support the annual preparation of the global commercial, marketing and operational Budget and Strategic Plan.
• · Support monthly and quarterly financial integration with the global FP&A team and processes, including KPI reporting requirements.
• · Manage month-end reporting activities to ensure availability of timely, complete, analyzed, and well-presented P&L, cash flow, and sales outlook for submission to management and global FP&A team.
• · Support financial modeling, scenario analysis, and business insights via financial and non-financial data to support the management decision process.
• · Prepare financial reports (such as Plans and Rolling LBEs) that meet the timing and presentation requirements, facilitating management review and decision making while ensuring data integrity and compliance with financial policies.
• · Establish and maintain an effective, efficient, and well-documented financial planning process for the sales and operational functions being supported, including coordination of a planning calendar with key dates and deliverables. This includes ongoing evaluation of options to streamline and automate financial processes
• · Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies

Financial Planning and Analysis Manager

Clinical Research

• Position Summary
• The Clinical Research Engineer is responsible for:
• - Gaining an in-depth knowledge of OrganOx FDA approved and investigational or research products, as well as associated clinical procedures
• - Serving as the subject matter expert on the device and procedures during IDE studies and research projects
• - Supporting training of OrganOx employees (e.g. Clinical Specialists) and customers on OrganOx approved, as well as IDE and research products and studies
• Major Responsibilities
• Under direction from the VP, Clinical Affairs and Training, the Clinical Research Enginer will be responsible for:
• ***Product Knowledge and Training***
• · Gaining an in-depth knowledge of OrganOx FDA approved and investigational/research products, as well as associated clinical procedures
• - Support the development of training and other support materials for FDA approved and investigational/research devices and procedures
• - Train investigational/research centers, Clinical Specialists, and other OrganOx personnel on investigational/research devices and procedures
• - Attend cases with investigational/research device as a technical and clinical resource for the staff at the investigational/research center
• - Interface with Development and Engineering in order to obtain answers to technical questions
• - Provide clinical and technical feedback on FDA approved and investigational/research device to Development and Engineering
• ***Clinical Studies***
• - Serve as a resource to investigational/research centers, as well as OrganOx personnel, regarding investigational/research devices and clinical study protocols
• - Support the development of clinical study protocols
• - Support sound and thorough data collection ensure data analysis in accordance with the protocol
• - Develop training and other support materials for clinical protocols, study procedures, data collection and review
• - Assist in the development and implementation of a study-specific database for clinical studies
• - Assist Clinical Research Associates with review of study data
• - Support writing and review of clinical study reports and the clinical portion of FDA submissions
• - Identify and report study protocol challenges and compliance issues to clinical management
• ***Management support***
• - Support OrganOx in maintaining current and developing professional relationships with investigators and investigational/research sites
• - Serve as a resource to clinical management for departmental decisions related to continuing quality improvement of process and procedures
• - Other duties as assigned by VP, Clinical Affairs & Training