Senior Manager, Clinical Partner Outsourcing

Objective / Purpose:

The Senior Manager Clinical Partner Outsourcing (CPO) ensures seamless execution of clinical studies by developing robust supplier contracts through commercial negotiations and resolving commercial and operational challenges. This role is responsible for ensuring a high level of fiscal discipline as well as enhancing cross-functional collaboration and ensuring studies start on time aligned to business requirements and Takeda standards and with the right commercial structures in place.

Accountabilities:

• Responsible for the development and finalization of study level contracts and change orders in partnership with key functions and aligned with Master Service Agreements to ensure predictable delivery quality and alignment to Takedas requirements values and policies.
• Lead ballparking contracting and commercial management of complex clinical studies understanding study requirements and translating into robust supplier contracts across a broad category of suppliers supporting R&D activities for assigned therapeutic areas and studies
• Apply appropriate commercial constructs aligned to business requirements to enable study start even with evolving assumptions
• Utilize cost models and workbooks to validate contract pricing and budget assumptions for complex agreements and develop enhancements to improve validation capabilities
• Drive negotiations with CROs and suppliers to secure optimal terms for Takeda
• Manage contract amendments throughout the study lifecycle
• Support study teams in completing final reconciliation at study closeout
• Develop close collaborative working relationships with clinical operations and other key stakeholders to improve understanding and engagement
• Generate preliminary cost estimates to support Study Execution Teams (SET) in budget planning
• Collaborate with study teams to address commercial/contractual challenges proactively identify potential issues develop contingency plans and escalate to Clinical Partner Outsourcing/SPO leadership as necessary
• Escalate issues through the appropriate channels when local resolution is not achievable
• Drive operational support & issue resolution by supporting teams in addressing operational and performance-related supplier issues
• Ensure consistency between contractual agreement and operational implementation
• Serve as a SME and lead continuous improvement initiatives to enhance performance and efficiency identify best practices through industry benchmarking.
• As a member of the CPO team anticipate and identify external industry trends impacting Takedas operating/cost model
• Ensure compliance with all applicable internal policies and procedures regulations support inspection readiness of all regulated activities.
• Lead or participate in special projects and initiatives to support the business

Education & Competencies (Technical and Behavioral):

• Bachelors degree required; advanced technical degree (e.g MBA) or certifications (e.g PMP CPA) preferred
• 7 years of experience in the pharmaceutical industry or clinical research environment
• Experience supporting a complex organization and demonstrated ability to work across functions and regions
• Proven experience in clinical procurement contract management or supplier relationship management
• Strong knowledge of clinical trial processes and regulatory requirements
• Experience in contract negotiations financial analysis and budget management.
• Familiarity with CRO and clinical outsourcing models including financial and commercial constructs
• Sound understanding of GCP ICH guidelines and clinical trial regulations
• Strong strategic thinking and project management skills
• Excellent communicator with strong written and verbal presentation skills

ADDITIONAL INFORMATION:

• The position will be based in Cambridge MA. This position is currently classified as remote by Takedas Hybrid and Remote Work policy.