Director, Clinical Site Budget Management

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 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 Kirins 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
Bachelors 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 $205000 to $220000. 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 Controllers data protection officer can be contacted at . Your personal data will be processed for the purposes of managing Controllers 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 Controllers 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 .

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.

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