Associate Director, Clinical Alliance 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 commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Summary:

The Vendor Management & Vendor Budget and Contract Management team focuses on Clinical Portfolio Financial Management, Vendor and Site Financial Management and Data Analytics. Clinical Alliance Management, Associate Director supports the Global Head of Clinical Vendor Budget and Contract Management in the creation, organization, and operational structure of vendor management and governance. This role involves overseeing relationships with external vendors who provide clinical trial services (including and not limited to 3rd party vendors, CRO’s, and strategic partnerships (In and Out-licensing engagements, co-development partnerships)), ensuring compliance with contractual obligations, regulatory requirements, company standards, and project timelines. By utilizing key deliverables from Business Operations Leads and Clinical Operations Leads, such as benchmarking, financial standard reports, and operational escalations, combined with creating deliverables such as KPIs and performance analysis, the Clinical Alliance Management, Associate Director drives vendor performance and efficiency. This position requires close understanding of the Business Operations Leads and strong collaboration with internal stakeholders, clinical operations, procurement, legal, and finance teams.

Essential Functions:

Vendor Management
•    Identify, evaluate, and select vendors for clinical trial services such as CROs, laboratories, and other specialized service providers with key stakeholder collaboration.
•    Negotiate contracts and service agreements with vendors, ensuring alignment with project budgets and timelines.
•    Maintain ongoing relationships with vendors, acting as the primary point of contact for issue resolution and performance management.
•    Conduct regular performance reviews and participate and contribute in CAPA resolutions where applicable to ensure compliance with regulatory requirements and company standards.

Support to Global Head and Sr. Management
•    Support the Global Head of Clinical Vendor Budget and Contract Management in developing and implementing the vendor management and governance framework. Including Vendor Level process map, Risk Categorization Tool, Metrics Framework Catalog, Performance & Metrics Review Process, Vendor Selection Scorecard and Feedback process.
•    Contribute to the strategic planning and execution of vendor management initiatives.
•    Provide insights and recommendations to enhance vendor governance and operational efficiency.

Project Improvement Efforts in coordination with the BOL and COL of each project
•    Monitor vendor performance metrics, risk management and key performance indicators (KPIs) to ensure quality and efficiency.
•    Work with internal project teams to align vendor activities with overall project goals and timelines.
•    Centralize the oversight of vendor interactions to ensure timely delivery of clinical trial services and optimize vendor performance.
•    Address and resolve escalated discrepancies or issues that arise during clinical trials.

KPIs and Performance Analysis 
•    Establish and monitor KPIs to assess vendor performance, quality, and efficiency. 
•    Train BOL on KPI’s and vendor performance day to day management) 
•    Conduct regular performance analysis to identify trends, address issues, and implement corrective actions.
•    Provide detailed performance reports to senior management, highlighting key insights and recommendations.
•    Monitor and report on vendor-related expenses, identifying opportunities for cost savings and efficiency improvements.
•    Utilize BOL Deliverables include the financial study outputs in the Vendor Management performance and governance structure.
•    Utilize data to evaluate vendor performance against industry standards and identify areas for improvement.
•    Implement best practices and standards derived from benchmarking to enhance vendor performance and efficiency.

Requirements:

Education
Bachelor’s degree in life sciences, business administration, or closely related field; advanced degree preferred.

Experience
Minimum of 10 years of progressive experience in clinical trial management, including substantial responsibilities in vendor oversight. Experience working within a global organization and managing international vendors is strongly preferred.

Technical Skills
•    In-depth knowledge of GCP, FDA regulations, and other relevant regulatory requirements.
•    Strong negotiation, contract management, and project management skills.
•    Excellent communication and interpersonal skills, with the ability to build and maintain relationships with external partners and internal stakeholders.
•    Proficiency in Microsoft Office Suite and clinical trial management systems and analytics tools.
•    Familiarity with clinical trial technologies and Analytics.

Non-Technical Skills
Ability to manage multiple projects and priorities in a fast-paced environment. Strong work ethic is required. Detail oriented and excellent follow through. Has the ability to flex and deal with ambiguity in a dynamic, fast-paced, high growth environment. Has a passion for personal learning and development to be able to grow with the company. Cultural sensitivity and ability to develop consensus within a multinational organization.

Working Conditions:

Requires up to 10% domestic and international travel. Occasional requires travel to vendor sites, clinical trial locations, and industry conferences. May involve working outside of regular business hours to accommodate global time zones and project deadlines.

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.

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