Senior Manager, Clinical Partner Outsourcing (CPO)
Takeda
9 hours ago
Remote friendly (United States)
United States
Operations
Objective / Purpose:
- Ensure seamless execution of clinical studies by developing robust supplier contracts through commercial negotiations and resolving commercial and operational challenges.
- Maintain fiscal discipline, enhance cross-functional collaboration, and ensure studies start on time and aligned to business requirements and Takeda standards.
Accountabilities:
- Develop and finalize study-level contracts and change orders aligned to Master Service Agreements.
- Lead ballparking, contracting, and commercial management of complex clinical studies and translate requirements into supplier contracts.
- Apply appropriate commercial constructs to enable study start, even with evolving assumptions.
- Use cost models/workbooks to validate contract pricing and budget assumptions; improve validation capabilities.
- Drive negotiations with CROs and suppliers to secure optimal terms.
- Manage contract amendments throughout the study lifecycle.
- Support study closeout reconciliation.
- Build close working relationships with clinical operations and other stakeholders.
- Generate preliminary cost estimates to support Study Execution Teams (SET) in budget planning.
- Address commercial/contractual challenges, identify issues early, develop contingencies, and escalate as needed.
- Escalate issues when local resolution is not achievable.
- Support operational issue resolution for supplier performance.
- Ensure contractual agreements are consistent with operational implementation.
- Serve as a SME; lead continuous improvement and benchmarking-based best practices.
- Anticipate external industry trends impacting operating/cost models.
- Ensure compliance with internal policies/procedures and applicable regulations; support inspection readiness.
- Lead or participate in special projects/initiatives.
Education & Competencies (Technical and Behavioral):
- Bachelor’s degree required; advanced degree (e.g., MBA) or certifications (e.g., PMP, CPA) preferred.
- 7+ years’ experience in pharmaceutical industry or clinical research.
- Experience supporting complex, cross-functional organizations across regions.
- Proven experience in clinical procurement, contract management, or supplier relationship management.
- Strong knowledge of clinical trial processes and regulatory requirements.
- Experience with contract negotiations, financial analysis, and budget management.
- Familiarity with CRO and clinical outsourcing models and commercial/financial constructs.
- Understanding of GCP, ICH guidelines, and clinical trial regulations.
- Strong strategic thinking and project management skills.
- Excellent written and verbal communication/presentation skills.
- Ensure seamless execution of clinical studies by developing robust supplier contracts through commercial negotiations and resolving commercial and operational challenges.
- Maintain fiscal discipline, enhance cross-functional collaboration, and ensure studies start on time and aligned to business requirements and Takeda standards.
Accountabilities:
- Develop and finalize study-level contracts and change orders aligned to Master Service Agreements.
- Lead ballparking, contracting, and commercial management of complex clinical studies and translate requirements into supplier contracts.
- Apply appropriate commercial constructs to enable study start, even with evolving assumptions.
- Use cost models/workbooks to validate contract pricing and budget assumptions; improve validation capabilities.
- Drive negotiations with CROs and suppliers to secure optimal terms.
- Manage contract amendments throughout the study lifecycle.
- Support study closeout reconciliation.
- Build close working relationships with clinical operations and other stakeholders.
- Generate preliminary cost estimates to support Study Execution Teams (SET) in budget planning.
- Address commercial/contractual challenges, identify issues early, develop contingencies, and escalate as needed.
- Escalate issues when local resolution is not achievable.
- Support operational issue resolution for supplier performance.
- Ensure contractual agreements are consistent with operational implementation.
- Serve as a SME; lead continuous improvement and benchmarking-based best practices.
- Anticipate external industry trends impacting operating/cost models.
- Ensure compliance with internal policies/procedures and applicable regulations; support inspection readiness.
- Lead or participate in special projects/initiatives.
Education & Competencies (Technical and Behavioral):
- Bachelor’s degree required; advanced degree (e.g., MBA) or certifications (e.g., PMP, CPA) preferred.
- 7+ years’ experience in pharmaceutical industry or clinical research.
- Experience supporting complex, cross-functional organizations across regions.
- Proven experience in clinical procurement, contract management, or supplier relationship management.
- Strong knowledge of clinical trial processes and regulatory requirements.
- Experience with contract negotiations, financial analysis, and budget management.
- Familiarity with CRO and clinical outsourcing models and commercial/financial constructs.
- Understanding of GCP, ICH guidelines, and clinical trial regulations.
- Strong strategic thinking and project management skills.
- Excellent written and verbal communication/presentation skills.