Senior Manager, Clinical Partner Outsourcing
Takeda
4 months ago
Remote
United States
$137,000 - $215,270 USD yearly
Operations
Objective / Purpose
- The Senior Manager, Clinical Partner Outsourcing (CPO) ensures seamless execution of clinical studies by developing supplier contracts through commercial negotiations and resolving commercial and operational challenges, supporting timely study starts aligned to business requirements and Takeda standards.
Responsibilities / Accountabilities
- Develop and finalize study-level contracts and change orders aligned with Master Service Agreements.
- Lead ballparking, contracting, and commercial management for complex clinical studies across a broad supplier category.
- Apply commercial constructs to enable study start, including with evolving assumptions.
- Use cost models/workbooks to validate pricing and budget assumptions; enhance validation capabilities.
- Drive negotiations with CROs and suppliers to secure optimal terms.
- Manage contract amendments throughout the study lifecycle.
- Support closeout reconciliation with study teams.
- Partner with clinical operations and stakeholders to improve engagement.
- Provide preliminary cost estimates to support Study Execution Teams (SET) budget planning.
- Address commercial/contractual challenges, identify issues, develop contingencies, and escalate as needed.
- Escalate issues when local resolution is not achievable.
- Support operational issue resolution with suppliers and ensure contractual agreement matches implementation.
- Serve as a SME; lead continuous improvement and benchmarking.
- Anticipate external industry trends impacting operating/cost models.
- Ensure compliance with applicable internal policies/procedures and regulatory requirements; support inspection readiness.
- Lead or participate in special projects.
Qualifications
- Bachelor’s degree required.
- 7+ years of experience in the pharmaceutical industry or clinical research environment.
Preferred Education / Certifications
- MBA or certifications such as PMP or CPA.
Required / Preferable Skills and Experience
- Experience supporting complex organizations 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/commercial constructs.
- Sound understanding of GCP, ICH guidelines, and clinical trial regulations.
- Strong strategic thinking and project management skills.
- Excellent written and verbal communication and presentation skills.
Benefits (if explicitly stated)
- May be eligible for short-term and/or long-term incentives.
- Medical, dental, vision insurance; 401(k) with company match; disability coverage; basic life insurance; tuition reimbursement; paid volunteer time off; company holidays; well-being benefits.
- Up to 80 hours of sick time per calendar year; up to 120 hours of paid vacation for new hires.
Location / Work Arrangement (additional information)
- Cambridge, MA (remote per Takeda’s Hybrid and Remote Work policy).
- The Senior Manager, Clinical Partner Outsourcing (CPO) ensures seamless execution of clinical studies by developing supplier contracts through commercial negotiations and resolving commercial and operational challenges, supporting timely study starts aligned to business requirements and Takeda standards.
Responsibilities / Accountabilities
- Develop and finalize study-level contracts and change orders aligned with Master Service Agreements.
- Lead ballparking, contracting, and commercial management for complex clinical studies across a broad supplier category.
- Apply commercial constructs to enable study start, including with evolving assumptions.
- Use cost models/workbooks to validate pricing and budget assumptions; enhance validation capabilities.
- Drive negotiations with CROs and suppliers to secure optimal terms.
- Manage contract amendments throughout the study lifecycle.
- Support closeout reconciliation with study teams.
- Partner with clinical operations and stakeholders to improve engagement.
- Provide preliminary cost estimates to support Study Execution Teams (SET) budget planning.
- Address commercial/contractual challenges, identify issues, develop contingencies, and escalate as needed.
- Escalate issues when local resolution is not achievable.
- Support operational issue resolution with suppliers and ensure contractual agreement matches implementation.
- Serve as a SME; lead continuous improvement and benchmarking.
- Anticipate external industry trends impacting operating/cost models.
- Ensure compliance with applicable internal policies/procedures and regulatory requirements; support inspection readiness.
- Lead or participate in special projects.
Qualifications
- Bachelor’s degree required.
- 7+ years of experience in the pharmaceutical industry or clinical research environment.
Preferred Education / Certifications
- MBA or certifications such as PMP or CPA.
Required / Preferable Skills and Experience
- Experience supporting complex organizations 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/commercial constructs.
- Sound understanding of GCP, ICH guidelines, and clinical trial regulations.
- Strong strategic thinking and project management skills.
- Excellent written and verbal communication and presentation skills.
Benefits (if explicitly stated)
- May be eligible for short-term and/or long-term incentives.
- Medical, dental, vision insurance; 401(k) with company match; disability coverage; basic life insurance; tuition reimbursement; paid volunteer time off; company holidays; well-being benefits.
- Up to 80 hours of sick time per calendar year; up to 120 hours of paid vacation for new hires.
Location / Work Arrangement (additional information)
- Cambridge, MA (remote per Takeda’s Hybrid and Remote Work policy).