Senior Manager, Clinical Partner Outsourcing - Boston - Takeda Pharmaceutical

Description

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Job DescriptionAt Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients.

Please make an application promptly if you are a good match for this role due to high levels of interest.

By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide

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 studiesApply appropriate commercial constructs, aligned to business requirements, to enable study start, even with evolving assumptionsUtilize cost models and workbooks to validate contract pricing and budget assumptions for complex agreements and develop enhancements to improve validation capabilitiesDrive negotiations with CRO's and suppliers to secure optimal terms for TakedaManage contract amendments throughout the study lifecycleSupport study teams in completing final reconciliation at study closeoutDevelop close collaborative working relationships with clinical operations and other key stakeholders to improve understanding and engagementGenerate preliminary cost estimates to support Study Execution Teams (SET) in budget planningCollaborate with study teams to address commercial/contractual challenges, proactively identify potential issues, develop contingency plans and escalate to Clinical Partner Outsourcing/SPO leadership as necessaryEscalate issues through the appropriate channels when local resolution is not achievableDrive operational support & issue resolution by supporting teams in addressing operational and performance-related supplier issuesEnsure consistency between contractual agreement and operational implementationServe 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 modelEnsure 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 businessEducation & Competencies (Technical and Behavioral): Bachelors degree required; advanced technical degree (e.g MBA) or certifications (e.g PMP, CPA) preferred7+ years of experience in the pharmaceutical industry or clinical research environmentExperience supporting a complex organization and demonstrated ability to work across functions and regionsProven experience in clinical procurement, contract management, or supplier relationship managementStrong knowledge of clinical trial processes and regulatory requirementsExperience in contract negotiations, financial analysis and budget management.

Familiarity with CRO and clinical outsourcing models, including financial and commercial constructsSound understanding of GCP, ICH guidelines, and clinical trial regulationsStrong strategic thinking and project management skillsExcellent communicator with strong written and verbal presentation skillsADDITIONAL INFORMATION:

The position will be based in Cambridge, MA.This position is currently classified as "remote" by Takeda's Hybrid and Remote Work policy.

Takeda Compensation and Benefits SummaryWe understand compensation is an important factor as you consider the next step in your career.

We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:
Boston, MAU.S.


Base Salary Range:
$137,000.00

- $215,270.00The 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-term incentives.

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.

EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob ExemptYesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment.

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An employer who violates this law shall be subject to criminal penalties and civil liability.