Kiniksa Pharmaceutical
Senior Financial Analyst, Clinical
Kiniksa Pharmaceutical, Lexington, Massachusetts, us, 02421
Reporting to the Vice President, Financial Planning & Analysis, the Senior Financial Analyst, Clinical will be responsible for supporting the business processes related to the financial oversight of the Company's clinical development programs, including the outsourcing and selection, contracting, and financial oversight of vendors.
This role is based in our Lexington office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.
Responsibilities (including, but not limited to):
* Maintain and manage monthly accruals and quarterly financial reconciliations, in combination with cash flows, for each program. Ensure monthly accounting is accurate by participating in Clinical Operations internal/external meetings to maintain knowledge of trial status, including current and upcoming issues with the potential for financial impact. Prepare reporting of monthly financial performance and prepare variance analysis* Coordinate the financial forecasts with program managers and Contract Research Organizations (CROs). Generate detailed study budget and summaries for all programs, including setting baseline for RFP processes. Review program change orders (CO) with vendors and modify forecasts accordingly* Provide support to Clinical Operations and Finance for continual assessment of service level metrics and key performance indicators, addressing and escalating areas of concern. Identify and monitor study-level analytics such as milestone adherence, operational cycle times (including enrollment), site activation progress, etc.* Assist with general FP&A activities such as maintaining the company's financial reporting system (FX Rates, Headcount) and prepare budget vs actual analysis. Identify monthly accruals for R&D functions* Support Clinical Operations and Purchasing management to define study-level resourcing plans and new vendor selection processes (e.g., RFI/RFP, bid defenses, etc.). Support Purchasing management as they liaise with the Clinical Operations, Legal, Finance and Quality Assurance teams to ensure new vendors are identified, selected and contracted per company policies and best business practices. Review vendor contracts (e.g., MSAs, SUAs, work orders, change orders) focusing on financial terms and conditions* Evaluate vendor proposal pricing and budgets, and provide guidance to the clinical study team during vendor selection activities. Compare vendor budgets, highlighting difference drivers.* Partner with Clinical Operations and Finance leaders to ensure financial data quality/integrity, including ensuring that vendor reports/invoices are accurate* Collect, analyze and integrate internal and external benchmarking data to support effective forecasting efforts (e.g., incorporate enrollment curves, site activations, etc. as the programmatic forecast is prepared)* Manage purchase orders and invoice process flow for all active clinical programs.* Oversee the financial closeout of vendors, in collaboration with Clinical Operations managers* Serve as subject matter expert for various internal process improvement initiatives related to clinical vendor and financial management* Perform other activities as assigned
Qualifications:
* 5+ years of experience in the pharmaceutical/biotech industry (sponsor or CRO)* Requires a BA/BS Degree (CPA or Masters-level degree preferred)* Experience with clinical trial budget, forecasting, financial metrics development and monitoring* Solid understanding of clinical study cost drivers, forecasting methodologies and creation/interpreting of key performance/quality indicators required* Experience with business systems/software* Current practical knowledge of Good Clinical Practices and FDA regulations for IND clinical trials is required; international clinical trial experience and knowledge of other country regulatory requirements is preferred* Proficient analytical and negotiation skills* Strong ability to understand strategic goals and deliver results for the company* Pragmatism and ability to manage multiple projects and prioritize needs effectively* Positive outlook and ability to quickly assess complex needs* Excellent listening, communication (written, spoken) and interpersonal skills, fostering team spirit* Consistent delivery of high-quality work* Strong commitment to compliance and ethical standards* Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)* Salary is commensurate with experience* Kiniksa Benefits Summary - USA
Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
This role is based in our Lexington office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.
Responsibilities (including, but not limited to):
* Maintain and manage monthly accruals and quarterly financial reconciliations, in combination with cash flows, for each program. Ensure monthly accounting is accurate by participating in Clinical Operations internal/external meetings to maintain knowledge of trial status, including current and upcoming issues with the potential for financial impact. Prepare reporting of monthly financial performance and prepare variance analysis* Coordinate the financial forecasts with program managers and Contract Research Organizations (CROs). Generate detailed study budget and summaries for all programs, including setting baseline for RFP processes. Review program change orders (CO) with vendors and modify forecasts accordingly* Provide support to Clinical Operations and Finance for continual assessment of service level metrics and key performance indicators, addressing and escalating areas of concern. Identify and monitor study-level analytics such as milestone adherence, operational cycle times (including enrollment), site activation progress, etc.* Assist with general FP&A activities such as maintaining the company's financial reporting system (FX Rates, Headcount) and prepare budget vs actual analysis. Identify monthly accruals for R&D functions* Support Clinical Operations and Purchasing management to define study-level resourcing plans and new vendor selection processes (e.g., RFI/RFP, bid defenses, etc.). Support Purchasing management as they liaise with the Clinical Operations, Legal, Finance and Quality Assurance teams to ensure new vendors are identified, selected and contracted per company policies and best business practices. Review vendor contracts (e.g., MSAs, SUAs, work orders, change orders) focusing on financial terms and conditions* Evaluate vendor proposal pricing and budgets, and provide guidance to the clinical study team during vendor selection activities. Compare vendor budgets, highlighting difference drivers.* Partner with Clinical Operations and Finance leaders to ensure financial data quality/integrity, including ensuring that vendor reports/invoices are accurate* Collect, analyze and integrate internal and external benchmarking data to support effective forecasting efforts (e.g., incorporate enrollment curves, site activations, etc. as the programmatic forecast is prepared)* Manage purchase orders and invoice process flow for all active clinical programs.* Oversee the financial closeout of vendors, in collaboration with Clinical Operations managers* Serve as subject matter expert for various internal process improvement initiatives related to clinical vendor and financial management* Perform other activities as assigned
Qualifications:
* 5+ years of experience in the pharmaceutical/biotech industry (sponsor or CRO)* Requires a BA/BS Degree (CPA or Masters-level degree preferred)* Experience with clinical trial budget, forecasting, financial metrics development and monitoring* Solid understanding of clinical study cost drivers, forecasting methodologies and creation/interpreting of key performance/quality indicators required* Experience with business systems/software* Current practical knowledge of Good Clinical Practices and FDA regulations for IND clinical trials is required; international clinical trial experience and knowledge of other country regulatory requirements is preferred* Proficient analytical and negotiation skills* Strong ability to understand strategic goals and deliver results for the company* Pragmatism and ability to manage multiple projects and prioritize needs effectively* Positive outlook and ability to quickly assess complex needs* Excellent listening, communication (written, spoken) and interpersonal skills, fostering team spirit* Consistent delivery of high-quality work* Strong commitment to compliance and ethical standards* Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)* Salary is commensurate with experience* Kiniksa Benefits Summary - USA
Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.