The Manager, Clinical Business Operations will provide support in developing effective clinical contractual agreements (such as Master Services Agreements, Work Orders, Amendments, Change Orders, Lab Agreements), and actively managing other clinical financial obligations.
This individual will be responsible for clinical outsourcing including: CRO/vendor management, vendor selection & oversight, sourcing process for clinical operations including Request for Proposal (RFP) development and execution, contract negotiations, contract management, setting of standards, cost savings development/tracking and budget management in support of the clinical development programs.
RESPONSIBILITIES
Recommend and/or assess potential CROs and vendors in collaboration with the Associate Director and other colleagues.
Work with Clinical Development on planning and management clinical study related outsourcing activities with enough communication.
Work with other SI function (Bio Metrics ,Regulatory, Drug Safety and, others) on supporting its outsourcing activities if necessary.
Facilitate creation and execution of all contract documents and manage the review and negotiation of contract terms and partner with Legal, Finance and other internal stakeholders as needed to finalize.
Builds and maintains business relationships and establishes partnerships with CROs, vendors, and other external partners including strategic partnerships and preferred provider relationships.
Ensure clinical programs are executed within projected budget, and promptly communicate any change in scope of budget.
Assist Finance with audits of payment and financial records to ensure accuracy and completeness.
Manage the latest estimate and annual/long range planning activities for Clinical.
Manage reporting activities as well as expenditure tracking and invoice payment for the monthly study PO report.
Support project tracking for Clinical R&D projects and partner with project managers to ensure accuracy of forecasts and expenses.
Prepare month end journal entries and ensure the adequacy of contractor accruals.
Support the global R&D financial systems, such as SPIRIT, for the Clinical organization. Manage the Clinical Development Resource tool. Support the JDE Purchasing system. Manage the Sharepoint invoice approval system. Train business partners on systems.
Manage all activities in accordance with company SOPs, FDA, & ICH guidelines and regulations.
Closely with Japan as well as Shionogis European office.
REQUIREMENTS
Bachelors Degree or equivalent education required, preferably in Life Sciences, Finance, or Business. MBA is a plus.
At least 5 years professional experience to include accounting, finance, sourcing, vendor negotiations, or operations management.
Pharmaceutical industry experience dealing with R&D functions. Experience dealing with a Clinical Development department is strongly preferred.
Excellent written and oral communication skills with ability to generate concise reports and verbal updates.
Demonstrated strong analytical skills.
Demonstrated high level of proficiency with Microsoft Office suite (Outlook, Word, Excel, PowerPoint) and Adobe. Experience working in Excel - including pivot tables, database & lookup formulas is a plus.
Must be flexible and adaptable to changing project priorities, work assignments and deadlines.
Hybrid work arrangements will allow work from home combined with your presence on-site at our US HQ in Florham Park, NJ.
To be considered for this position, you must apply and meet the requirements of this opportunity.
We look forward to reviewing your resume & qualifications.
Please be aware that Shionogi Inc. mandates COVID-19 vaccination of all employees and contractors regardless of work location. Accommodations may be made in accordance with applicable law.
DISCLAIMER
The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilitiesmay change or be assigned at any time with or without notice.
EEO
Shionogi Inc. is an equal opportunity/affirmative action employer.
All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law.
It is the policy of Shionogi Inc. to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractors legal duty to furnish information. 41 CFR 60-1.35(c)
Clinical Development
