Senior Manager/Manager, Clinical Business Operations

Overview:

• 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 Shionogi’s European office colleagues as required.

• Bachelor’s Degree or equivalent education required, preferably in Life Sciences, Finance, or Business. MBA is a plus.
• A minimum of 4-5 years for manager and 5-6 years for senior manager experience to include outsourcing for clinical trials, vendor negotiations, or operations management, accounting, and finance.

• 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 are a plus.
• Must be flexible and adaptable to changing project priorities, work assignments and deadlines.
• Must live a commutable distance from our Florham Park Corporate offices.

• Ability to articulate clearly and conduct verbal presentations with large and small audiences.
• Ability to travel via automobile and/or airplane.
• Ability to view video display terminal images
• Ability to operate a computer keyboard and telephone.
• Ability to sit for extended periods of time – up to four (4) hours at a time.
• Ability to lift, tug, pull up to fifteen (15) pounds.

EEO:

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.