Senior Manager/Manager, Clinical Business Operations

Shionogi - Florham Park, NJ

Full-time - Mid Level

Florham Park, NJ

Merchant Wholesalers, Nondurable Goods

About the position

The Senior Manager/Manager of Clinical Business Operations at Shionogi Inc. is responsible for overseeing clinical outsourcing and managing relationships with vendors. This role involves vendor selection, contract management, budget negotiations, and ensuring compliance with clinical development programs. The position requires collaboration with various internal and external stakeholders to facilitate effective clinical operations and financial management.

Responsibilities

• Research, review and 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 effective communication.
• Collaborate with global functions such as Biometrics, Regulatory, and Drug Safety to support outsourcing activities.
• Facilitate creation and execution of all contract documents and manage the review and negotiation of contract terms in collaboration with Legal and Finance.
• Build and maintain business relationships with CROs, vendors, and external partners, establishing strategic partnerships.
• Ensure clinical programs are executed within projected budgets and communicate any changes in scope or budget promptly.
• Collaborate with Finance on management of the latest estimates and annual/long-range planning activities for Clinical.
• Manage all activities in accordance with company SOPs, FDA, and ICH guidelines and regulations.
• Collaborate closely with headquarters in Japan and Shionogi's European office colleagues as required.

Requirements

• Bachelor's Degree or equivalent education required, preferably in Life Sciences, Finance, or Business; MBA is a plus.
• 4-5 years of experience for Manager and 5-6 years for Senior Manager in outsourcing for clinical trials, vendor negotiations, or operations management.
• Pharmaceutical industry experience preferred, particularly in Research and Development functions.
• Experience with Clinical Development departments and global clinical trial experience.
• Excellent written and oral communication skills with the ability to generate concise reports and verbal updates.
• Strong analytical skills and proficiency with Microsoft Office suite and Adobe.
• Experience working in Excel, including pivot tables and database & lookup formulas.

Nice-to-haves

• Flexibility and adaptability to changing project priorities, work assignments, and deadlines.