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Senior Clinical Operations Manager - Cell Therapies

at Takeda Pharmaceuticals in Montpelier, Vermont, United States

Job Description

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

OBJECTIVES:

The Senior Clinical Operations Manager will lead study operational strategy and planning and oversee execution of clinical studies for Takeda’s cell therapy projects, supporting clinical strategy defined in Clinical Development Plan.

In close collaboration with the Global Project Leader, Clinical Operations Leader, and other key functions, the COM will:

+ Oversee the execution of studies in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget

+ Oversee Strategic Partners and/or other CROs and other 3rd party vendors (e.g., labs) to meet Takeda’s obligations described in ICH-GCP and Takeda’s business objectives

Furthermore, the role will engage with the broader Development Operations community within Takeda and participate in global initiatives representing Development Operations in support of Takeda R&D objectives.

ACCOUNTABILITIES:

+ Accountable for planning and operational strategy and execution for cell therapy stud(ies)

+ Provides subject matter expertise and operational input into protocol synopsis, final protocol and other study related documents

+ Challenges study team to ensure operational feasibility, inclusive of patient and site burden

+ Validates budget and ensures impacts are adequately addressed

+ Participates in country and site feasibility/selection process, with a focus on providing country insights, corporate alignment and therapeutic expertise to ensure alignment between study execution plan and program strategy

+ Challenges study team to ensure timelines meet the needs of the clinical development plan

+ Ensure new team members and vendors are appropriately onboarded

+ During Early Engagement with Strategic Partner(s) and/or other CROs, lead the development of the Operational Strategy in preparation for Operational Strategy Review; focus on ensuring accurate assumptions are applied and robust risk management plans are in place

+ Provide oversight/support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidly

+ Responsible for study budget planning and management and accountable for external spend related to study execution. Works closely with the Clinical Operations Leader, Global Program Management, and Finance to ensure on a regular basis that budgets, enrollment, and gating are accurate; Communicates study status, cost and issues to Clinical Operations Program Leader; serve as escalation point for third party vendors managed by Strategic Partner and/or other CROs

+ Oversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor, including escalation of issues to governance committees when warranted;

+ Specific areas of responsibilities include, but are not limited to:

+ Review and approval of key monitoring documents/plans, periodic review of outputs, decisions and actions related to monitoring

+ Review and endorsement of relevant study plans, as applicable

+ Study team meeting management and attendance when necessary; regular review of meeting agendas and minutes

+ Review of outcomes/actions related to protocol deviations review; primary purpose of review is to support the identification of trends across sites and/or the study

+ Documented review and monitoring of issues, risks and decisions at the study level and implementation of appropriate mitigation strategies

+ In partnership with data management, review and pressure test all database timelines and plans; review and clean data; ensure strong linkage between the strategy (i.e., filing/registration, data generation, etc.) with the tactical plan for database lock and CSR

+ Ensure studies are “inspection ready” at all times; may be involved in regulatory inspections by preparing for and/or attending the inspections

+ Represent the Clinical Operations Manager role in functional initiatives or working groups

+ Help onboard / mentor more junior COMs

+ May assist the program Clinical Program Leader in his/her role, as required

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:

Education:

+ Bachelor’s Degree or international equivalent required, Life Sciences preferred

Required:

+ 6+ years’ experience in pharmaceutical industry and/or clinical research organization, including 4+ years clinical study management

+ Experience must include either early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs. Oncology experience required, cell therapy experience preferred

+ Strong knowledge of clinical study reporting requirements

+ Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes

+ Advanced knowledge of medical terminology, medical coding, laboratory reference ranges, clinical diagnostic procedures, anatomy/physiology and nature of disease processes

+ Knowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required

+ Demonstrated excellence in project/program management and matrix leadership

Knowledge and Skills:

+ Experience with project leadership and management systems and methodology

+ Multi-faceted background with direct involvement or experience working with functions from multiple divisions

+ Expert knowledge in the overall pharmaceutical drug development process

+ Demonstrated ability to build consensus and drive resolution of issues while maintaining positive working relationships across functions; negotiation and strong persuasive abilities

+ Strong written and verbal Communication Skills: ability to express oneself clearly and concisely to external partners, vendors or with others within the team; ability to message key issues appropriately and document issues and/or concerns concisely and comprehensively; ability to adjust language and/or terminology appropriate for the audience; demonstrated ability to clearly and concisely communicate / present key information to senior management

+ Analytical and Problem Solving Skills: ability to identify the critical issues of problems or opportunities using appropriate information; determines the causes and possible solutions to the problem

+ Strategic Implementation: ability to develop, implement and monitor the overall clinical operations strategy

+ Leadership Skills: develops and uses knowledge and interpersonal skills to influence and guide others towards the accomplishment of Takeda’s goals and objectives; requires the flexibility and tolerance to best manage change and differing opinions with dip

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Job Posting: JC218543082

Posted On: Jul 14, 2022

Updated On: Dec 08, 2022

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