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 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

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 Takeda’s Hybrid and Remote Work policy.

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.