The SeniorManager, Clinical Business Operations will be responsible for clinical outsourcing and relationship management activities including vendor selection, conducting Request for Proposal (RFPs) proposal review and analysis and budget negotiations, development and execution, contract management throughout life cycle of study, setting of standards, cost savings development/tracking and budget management in support of the clinical development programs, assist with and provide support in developing effective clinical contractual agreements such as Confidentiality agreements as needed, Master Services Agreements, Work Orders, Amendments, Change Orders, Lab Agreements and any other type of agreements needed for clinical studies, actively managing other clinical financial obligations, CRO/vendor management, vendor selection & oversight, sourcing process for clinical operations.
Responsibilities
Research, review and/or assess potential CROs and vendors in collaboration with the Director and other colleagues based on needs.
Work with Clinical Development on planning and management of clinical study related outsourcing activities with enough communication.
Work with other functions globally (Biometrics team, Data Management, Programming and Statistics, Regulatory, Drug Safety and, other functions) on supporting all applicable outsourcing activities.
Facilitate creation and execution of all contract documents and manage the review and negotiation of contract terms and partner in collaboration 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.
Collaborate with Finance on management of the latest estimate (LE) and annual/long range planning activities for Clinical.
Manage all activities in accordance with company SOPs, FDA, & ICH guidelines and regulations.
Collaborate closely with headquarters in Japan as well as Shionogis European office colleagues as required.
Requirements
Bachelors Degree or equivalent education required, preferably in Life Sciences, Finance, or Business. MBA is a plus.
6 + years experience to include outsourcing for clinical trials, vendor negotiations, or operations management, accounting, and finance.
Pharmaceutical industry experience strongly preferred as well as dealing with Research and Development functions. Experience dealing with a Clinical Development department and Global clinical trial experience.
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
