Director, Clinical Site Budget Management
Apply NowCompany: Kyowa Kirin North America
Location: Princeton, NJ 08540
Description:
Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario.
Summary:
The Clinical Site Budget Management Director within Global Clinical Business Operations oversees the development, payments, and analytics of all global site budgets. The Director is responsible for managing the financial aspects of clinical trial study sites, including the creation of site budgets, overseeing payments, and providing detailed analytics. This role ensures that all financial activities related to clinical sites are executed efficiently and in compliance with regulatory requirements, company policies, and industry standards.
Essential Functions:
Site Budget Development, Analysis and Estimation
Develop and negotiate clinical site budgets in collaboration with cross-functional teams, including Clinical Operations, Clinical Science, Finance, and Legal.
Ensure budgets are competitive and fair, reflecting the scope of work and market conditions.
Monitor and adjust budgets as necessary throughout the lifecycle of the clinical trial.
Review protocol synopses and draft protocols to understand procedures and schedule of patient assessments to identify key cost drivers.
Leverage best practice databases and historical site costs data to derive estimated per patient costs estimates for study team planning.
Determine appropriate budget line items based on final protocol.
Develop study budget template and obtain study team approval.
Complete site budgets for all sites on assigned studies
Leverage benchmark pricing database (Grants Plan), historical price data and sound financial judgement to determine budget line-item costs.
Calculate acceptable negotiation parameters for all key budget line items (high, mid, low) that are in line with and support overall Kyowa Kirin financial goals.
Collaborate with Study Teams to finalize budgets for submission to Sites/CRO
Support the calculated negotiation parameters for all key budget line items (High, mid, low) that are in line with, and support overall Kyowa Kirin financial goals.
Collaborate with Study Team to finalize budgets for submission to Sites/CRO.
FMV, Compliance and Documentation:
Ensure that all site-related financial and contractual activities comply with Good Clinical Practice (GCP), FDA regulations, and other relevant regulatory requirements.
Maintain accurate and complete documentation of all budgets, contracts, and payment activities.
Support audits and inspections by regulatory authorities and internal quality assurance teams.
Implement and adhere to all transparency regulatory requirements and FMV obligations globally.
Align to the study design and effort required of each study stie.
Budget Negotiation
In collaboration with COL, support the budget negotiation for each site.
Provide rationale for all budget line items and promptly respond to any site or CRO queries regarding budget items.
Proactively drive sites and CROs to reach agreement on budget line items in line with approved budget parameters.
Work with Study Teams, sites and CROs to resolve disagreements on budget line items, escalate as appropriate where agreement within parameters cannot be reached.
Track communication and status of all site budget development, budget amendments and budget negotiations.
Advocate for appropriately controlling costs in line with corporate objectives in all site budget negotiations.
Ongoing Budget Maintenance
Build and maintain strong relationships with Study Teams, CRO, and sites to maintain awareness of any changes that may impact budgets or site and/or vendor contracting.
Attend study team meetings/CRO calls to gather information that may impact budget development and management.
Act as primary contact for all internal and external questions regarding site budgets and related parameters.
Update all site budgets based on protocol amendments.
Clinical Trial Agreements
Collaborate with Legal to draft, negotiate and complete the Clinical Trial Agreement (CTA) package (including approved budgets) for each site.
Act as first point of contact for any CTA Budget & payment terms-related questions from sites/CROs.
Escalate any legal feedback to Legal, as appropriate!
Facilitate internal Budget/payments terms approval and stakeholder negotiation to resolve complex issues and assist in disputes.
Review existing Clinical Trial Agreements (CTAs)/budgets to gauge performance and identify where improvements can be made.
Evaluate terms and conditions of contracts using Legal Department-approved playbooks, drive contracting process, and escalate to Legal Department, as appropriate.
Assist in the maintenance of Kyowa Kirin's contract database.
Site Payments Management:
Oversee the processing of payments to clinical sites, ensuring timely and accurate disbursement of funds.
Develop and implement payment schedules and mechanisms that comply with contractual agreements and regulatory guidelines.
Resolve payment discrepancies and issues with clinical sites promptly and effectively.
Supporting the reconciliation of site payments with responsible parties, including Study Team and Kyowa Kirin's third-party payment vendors including CRO payments to sites.
Supporting Clinical Operations to address and resolve any queries or issues regarding payment to sites to optimize the value of site payment vendor relationship.
Serving as subject matter expert and liaison to Kyowa Kirin's site payment process vendor for all site budget related matters; and
Serving as initial point of escalation for site budget related items that impact site payments.
Site Financial Analytics and Reporting:
Provide detailed financial analysis and reporting on clinical trial budgets and payments.
Utilize data analytics tools to generate insights and identify trends to support decision-making.
Prepare regular financial reports for senior management and other stakeholders.
Stakeholder Collaboration:
Work closely with clinical site staff, investigators, and other external partners to ensure smooth financial operations.
Collaborate with internal teams, including Clinical Operations, Project Management, and Finance, to align budgetary goals and objectives.
Serve as the primary point of contact for all budget-related inquiries from internal and external stakeholders.
Process Improvement:
Identify opportunities to streamline budget development, payment processes, and financial reporting.
Implement best practices and innovative solutions to improve efficiency and accuracy.
Stay updated on industry trends, regulatory changes, and advancements in financial management tools.
Oversee the processing of payments to clinical sites, ensuring timely and accurate disbursement of funds.
Develop and implement payment schedules and mechanisms that comply with contractual agreements and regulatory guidelines.
Requirements:
Education
Bachelor's degree in finance, Accounting, Business Administration, or closely related discipline. An advanced degree or relevant certification (e.g., CPA, CFA) is preferred.
Experience
At least 10 years of experience in clinical trial budgeting, financial management, or a related area within the pharmaceutical or biotech industry.
Technical Skills
Strong financial acumen and analytical skills. Proficiency in financial software and data analytics tools. Excellent negotiation skills. Strong written, verbal, and listening communication skills: articulate and effective communicator and presenter, able to describe complex problems and solutions in understandable terms; Outstanding interpersonal skills that enable inclusion of people across the internal and external organizations to make efficient collaboration.
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. ("Controller"), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing [redacted]. Controller's data protection officer can be contacted at [redacted]. Your personal data will be processed for the purposes of managing Controller's recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 ("GDPR") as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller's behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.
Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at [redacted].
Recruitment & Staffing Agencies
Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.
#LI-TT1 #Hybrid
Summary:
The Clinical Site Budget Management Director within Global Clinical Business Operations oversees the development, payments, and analytics of all global site budgets. The Director is responsible for managing the financial aspects of clinical trial study sites, including the creation of site budgets, overseeing payments, and providing detailed analytics. This role ensures that all financial activities related to clinical sites are executed efficiently and in compliance with regulatory requirements, company policies, and industry standards.
Essential Functions:
Site Budget Development, Analysis and Estimation
Develop and negotiate clinical site budgets in collaboration with cross-functional teams, including Clinical Operations, Clinical Science, Finance, and Legal.
Ensure budgets are competitive and fair, reflecting the scope of work and market conditions.
Monitor and adjust budgets as necessary throughout the lifecycle of the clinical trial.
Review protocol synopses and draft protocols to understand procedures and schedule of patient assessments to identify key cost drivers.
Leverage best practice databases and historical site costs data to derive estimated per patient costs estimates for study team planning.
Determine appropriate budget line items based on final protocol.
Develop study budget template and obtain study team approval.
Complete site budgets for all sites on assigned studies
Leverage benchmark pricing database (Grants Plan), historical price data and sound financial judgement to determine budget line-item costs.
Calculate acceptable negotiation parameters for all key budget line items (high, mid, low) that are in line with and support overall Kyowa Kirin financial goals.
Collaborate with Study Teams to finalize budgets for submission to Sites/CRO
Support the calculated negotiation parameters for all key budget line items (High, mid, low) that are in line with, and support overall Kyowa Kirin financial goals.
Collaborate with Study Team to finalize budgets for submission to Sites/CRO.
FMV, Compliance and Documentation:
Ensure that all site-related financial and contractual activities comply with Good Clinical Practice (GCP), FDA regulations, and other relevant regulatory requirements.
Maintain accurate and complete documentation of all budgets, contracts, and payment activities.
Support audits and inspections by regulatory authorities and internal quality assurance teams.
Implement and adhere to all transparency regulatory requirements and FMV obligations globally.
Align to the study design and effort required of each study stie.
Budget Negotiation
In collaboration with COL, support the budget negotiation for each site.
Provide rationale for all budget line items and promptly respond to any site or CRO queries regarding budget items.
Proactively drive sites and CROs to reach agreement on budget line items in line with approved budget parameters.
Work with Study Teams, sites and CROs to resolve disagreements on budget line items, escalate as appropriate where agreement within parameters cannot be reached.
Track communication and status of all site budget development, budget amendments and budget negotiations.
Advocate for appropriately controlling costs in line with corporate objectives in all site budget negotiations.
Ongoing Budget Maintenance
Build and maintain strong relationships with Study Teams, CRO, and sites to maintain awareness of any changes that may impact budgets or site and/or vendor contracting.
Attend study team meetings/CRO calls to gather information that may impact budget development and management.
Act as primary contact for all internal and external questions regarding site budgets and related parameters.
Update all site budgets based on protocol amendments.
Clinical Trial Agreements
Collaborate with Legal to draft, negotiate and complete the Clinical Trial Agreement (CTA) package (including approved budgets) for each site.
Act as first point of contact for any CTA Budget & payment terms-related questions from sites/CROs.
Escalate any legal feedback to Legal, as appropriate!
Facilitate internal Budget/payments terms approval and stakeholder negotiation to resolve complex issues and assist in disputes.
Review existing Clinical Trial Agreements (CTAs)/budgets to gauge performance and identify where improvements can be made.
Evaluate terms and conditions of contracts using Legal Department-approved playbooks, drive contracting process, and escalate to Legal Department, as appropriate.
Assist in the maintenance of Kyowa Kirin's contract database.
Site Payments Management:
Oversee the processing of payments to clinical sites, ensuring timely and accurate disbursement of funds.
Develop and implement payment schedules and mechanisms that comply with contractual agreements and regulatory guidelines.
Resolve payment discrepancies and issues with clinical sites promptly and effectively.
Supporting the reconciliation of site payments with responsible parties, including Study Team and Kyowa Kirin's third-party payment vendors including CRO payments to sites.
Supporting Clinical Operations to address and resolve any queries or issues regarding payment to sites to optimize the value of site payment vendor relationship.
Serving as subject matter expert and liaison to Kyowa Kirin's site payment process vendor for all site budget related matters; and
Serving as initial point of escalation for site budget related items that impact site payments.
Site Financial Analytics and Reporting:
Provide detailed financial analysis and reporting on clinical trial budgets and payments.
Utilize data analytics tools to generate insights and identify trends to support decision-making.
Prepare regular financial reports for senior management and other stakeholders.
Stakeholder Collaboration:
Work closely with clinical site staff, investigators, and other external partners to ensure smooth financial operations.
Collaborate with internal teams, including Clinical Operations, Project Management, and Finance, to align budgetary goals and objectives.
Serve as the primary point of contact for all budget-related inquiries from internal and external stakeholders.
Process Improvement:
Identify opportunities to streamline budget development, payment processes, and financial reporting.
Implement best practices and innovative solutions to improve efficiency and accuracy.
Stay updated on industry trends, regulatory changes, and advancements in financial management tools.
Oversee the processing of payments to clinical sites, ensuring timely and accurate disbursement of funds.
Develop and implement payment schedules and mechanisms that comply with contractual agreements and regulatory guidelines.
Requirements:
Education
Bachelor's degree in finance, Accounting, Business Administration, or closely related discipline. An advanced degree or relevant certification (e.g., CPA, CFA) is preferred.
Experience
At least 10 years of experience in clinical trial budgeting, financial management, or a related area within the pharmaceutical or biotech industry.
Technical Skills
Strong financial acumen and analytical skills. Proficiency in financial software and data analytics tools. Excellent negotiation skills. Strong written, verbal, and listening communication skills: articulate and effective communicator and presenter, able to describe complex problems and solutions in understandable terms; Outstanding interpersonal skills that enable inclusion of people across the internal and external organizations to make efficient collaboration.
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. ("Controller"), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing [redacted]. Controller's data protection officer can be contacted at [redacted]. Your personal data will be processed for the purposes of managing Controller's recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 ("GDPR") as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller's behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.
Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at [redacted].
Recruitment & Staffing Agencies
Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.
#LI-TT1 #Hybrid