Senior Manager, Clinical Partner Outsourcing

3316 Takeda Development Center Americas•Boston, MA

6d•Remote

About The Position

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.

Requirements

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

Responsibilities

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 Takeda’s 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 CRO’s 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 Takeda’s 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