Director, Clinical Site Budget Management at KYOWA KIRIN INC

Princeton, New Jersey, United States -

Full Time

Start Date

Immediate

Expiry Date

16 Dec, 25

Salary

220000.0

Posted On

17 Sep, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Financial Acumen, Analytical Skills, Negotiation Skills, Communication Skills, Interpersonal Skills, Budget Development, Compliance, Documentation, Financial Analysis, Reporting, Stakeholder Collaboration, Process Improvement, Data Analytics, Contract Management, Site Payments Management

Industry

Pharmaceutical Manufacturing

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 translate science into smiles by delivering therapies 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, North Carolina, and Mississauga, 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: 1. Site Budget Development & Estimation • Develop and negotiate clinical site budgets in alignment with protocol scope, market conditions, and corporate goals. • Utilize historical data, benchmarks, and financial tools (e.g., Grants Plan) to create accurate cost estimates. • Create budget templates, define negotiation parameters, and finalize budgets across assigned studies. 2. Budget Negotiation • Support and lead budget negotiations with sites and CROs, providing clear rationale for all line items. • Collaborate with study teams to resolve disputes, escalating as needed. • Track communications, amendments, and negotiation outcomes while maintaining alignment with financial objectives. 3. FMV, Compliance & Documentation • Ensure compliance with GCP, FDA, FMV, transparency regulations, and internal policies. • Maintain accurate and complete documentation of all budgets, contracts, and payment activities. • Support audits, inspections, and quality assurance reviews. 4. Clinical Trial Agreements (CTAs) • Partner with Legal to draft, negotiate, and finalize CTAs, including budgets and payment terms. • Serve as the first point of contact for CTA-related financial queries. • Support the management and improvement of Kyowa Kirin’s contract database. 5. Site Payments Management • Oversee timely and accurate site payments, ensuring adherence to contracts and regulatory standards. • Manage payment schedules, resolve discrepancies, and support reconciliation with CROs and third-party vendors. • Act as subject matter expert and escalation point for site payment processes. 6. Financial Analysis & Reporting • Deliver financial analysis, forecasts, and regular reporting on site budgets and payments. • Use analytics tools to identify trends and support data-driven decision-making. • Prepare reports and presentations for senior leadership and key stakeholders. 7. Stakeholder Collaboration • Collaborate with investigators, site staff, CROs, and internal teams (Clinical Operations, Project Management, Finance, Legal) to ensure smooth financial operations. • Serve as the primary contact for all site budget-related inquiries. • Build and maintain strong cross-functional relationships to align financial strategies. 8. Process Improvement • Identify and implement best practices to streamline budget development, payment processes, and financial reporting. • Monitor industry trends and regulatory changes to enhance compliance and efficiency. • Introduce innovative solutions to improve accuracy and timeliness of financial operations. 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. The anticipated salary for this position will be $205,000 to $220,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs. The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including: 401K with company match Discretionary Profit Share Annual Bonus Program (Sales Bonus for Sales Jobs) Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision) HSA & FSA Programs Well-Being and Work/Life Programs Life & Disability Insurance Concierge Services Long Term Incentive Program (subject to job level and performance) Pet Insurance Tuition Assistance Employee Referral Awards The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. 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 kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. 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 usprivacyoffice@kyowakirin.com. 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 #Princeton

Responsibilities

The Director oversees the development, payments, and analytics of all global site budgets for clinical trials. This role ensures efficient execution of financial activities related to clinical sites in compliance with regulatory requirements and company policies.