Johnson & Johnson キャリア

【Janssen】 JAPAN, Clinical Program Leader (Japan Medical Affairs Operation Lead)

千代田区, 東京都
Clinical Trial Administration


仕事内容

Requisition ID: 1805663301W

POSITION TITLE

【Janssen】 JAPAN, Clinical Program Leader (Japan Medical Affairs Operation Lead)

 

POSITION SUMMARY

•Reporting to the MAO Clinical Operations Head (COH), the MAO CPL is accountable for the successful planning, execution and reporting of assigned Japan and/or regional data generation activities. This includes adequate resource planning and allocation; meeting deliverables within agreed timelines, budget, and with high quality per company procedures and regulatory requirements. 

 

•The MAO CPL acts as the single point of end-to-end accountability at the portfolio/program level.

For the assigned portfolio/program, the CPL will manage relationships with global, regional and local Medical Affairs teams and other internal trial sponsors, as well as with other enterprise sectors, as applicable. 

He/she will be responsible for the coordination of all activities within Global Clinical Development Operations (GCDO) functions, R&D Operations (RDO) and / or with any external service providers e.g. contract research organization (CRO).

 

•The MAO CPL will lead a team of Global Trial Managers (GTMs),Trial Managers (TMs) and Global Trial Manager Clinical Trial Assistants (GTM-CTA).

Along with line management responsibilities, the CPL will support the training needs and development of their associates to meet the enterprise wide leadership standards for current and future employment opportunities while valuing a diverse work force.

 

•The MAO CPL has the primary accountability at the portfolio/program level within the GCDO organization. This includes providing operational leadership to their team’s project activities within a matrix organization starting from protocol development to delivery of final Clinical Study report (CSR) or other deliverable(s), according to planned milestones, within budget, and with high quality standards per company procedures and regulatory requirements; as well as driving issue identification and resolution, contingency planning, and decision-making.

 
 

PRINCIPAL RESPONSIBILITIES

■Becomes the single point of end-to-end accountability for the assigned portfolio/programs.

 

■Drives the start-up of assigned portfolio/programs

•Align on project strategy with the Medical Affairs team and other internal trial sponsors, as well as with other enterprise sectors, as applicable.

•Provide operational input in the design and implementation of the protocol including sourcing decision per the clinical operating model; either to be executed by GCDO or an external service provider.

•Discuss Clinical Development Plans and key operational questions with the COH, as appropriate

•Ensure GCDO or external service provider(s) is provided with the Protocol Design Elements/Protocol and critical operational elements in a timely fashion to allow optimal project preparation.

•Drive the Request for Service (RFS) process; partnering with Global Clinical Operations (GCO); Integrated Data Analysis & Reporting (IDAR); and other GCDO functions as well as RDO Centers of Excellence (COEs) such as Quantitative Sciences (QS), Pharmaceutical Development & Manufacturing Sciences (PDMS ), and  Clinical Forecasting & Analytics (CF&A) in the preparation and assumptions that make up the RFS. As applicable, compile project proposals via the Central Business Operations.

 

■Oversees the execution and close out of assigned portfolio/programs

•Ensures effective budget management for all projects. Partner with the Functional Planning (FP) group for project related milestones and adequate resources. Ensures accurate trial budget management and reconciliation of all trials for both Out of Pocket (OOP) costs and FTE costs.  Oversees GTMs and TMs in the overall contract management, including review & approval of external service provider (ESP) contracts, change orders and ensures services are delivered per contract.

•Monitor resource availability and ensure operational consistency across all activities of the Study Management Teams.

•Promote optimal communication between the GTMs/TMs/GTM-CTAs and GCDO functions, internal trial sponsors, Global Medical Safety (GMS), Quality Management & Training (QM&T), Clinical Quality Assurance (CQA) and external service providers

•Ensure timely status updates on project deliverables are provided to the Medical Affairs Team, other internal trial sponsors and/or other enterprise sectors, as applicable.

 

■Identifies and proactively manages issues in a timely manner

•Communicate regularly with the COH on all issues and risks related to project resources, timelines and budget. Make recommendations for solutions and align with the COH on the Action Plan.

•Work with relevant project stakeholders and Study Management Teams to implement solutions/Action Plan.

 

■Ensures that all project objectives are met according to all applicable regulations, legislations, guidelines and internal SOPs/policies.

 

■Manages and supports training and development needs of direct reports to meet the enterprise wide leadership standards for current and future employment opportunities while valuing a diverse work force.

 

■As applicable, acquires and sustains advanced knowledge of the appropriate Therapeutic Area, product and project setting

 

■Establishes strong relationships with the COH and other Program Leaders within GCDO across all regions and Therapeutic Areas.

 
 

Decision Making Responsibilities

•Evaluates operational implications of clinical development plans and study design

•Provides recommendations to COH on project execution strategies and People Management-related topics.

•Contributes to the design, development, and evaluation of the Clinical Operations processes and standards

 

WORKING RELATIONSHIPS/INTERFACE

Internal contacts:

COHs, other CPLs, GTMs and GTM-CTAs, GCO Country Heads, Regional and Country Medical Affairs teams, GCDO functions, RDO COEs FP, PDMS, Finance Department, Legal, , Procurement ( JRP), Quality Management & Training group; Study Management Teams , and other J&J enterprise sectors, as applicable.

 
External contacts:

external service providers, clinical investigative sites and their research staff.



資格

EDUCATION & EXPERIENCE REQUIREMENTS

 

•Bachelor’s Degree or equivalent required. Advanced Degree in a scientific discipline and/or Master Degree is preferred.

•At least 10 years professional experience in clinical trials within a pharmaceutical company and/or a CRO.

•Expertise in the areas of drug development, clinical operations, strategic planning and in-depth knowledge of Medical Affairs.

•Effective leadership skills and proven ability to foster team productivity and cohesiveness. Excellent communication skills and the innate flexibility to work in a rapidly growing and highly matrixed organization.

•Full understanding of all logistical aspects when running interventional and/or non-interventional clinical studies regionally and locally, and good understanding on the therapeutic areas where J&J is involved.

•Experience in managing and mentoring clinical operations team members.

•Proficient in speaking and writing the Japanese and English.



プライマリ場所
日本-東京都-千代田区
組織
Janssen Pharmaceutical K.K. (7195)
ジョブ
Clinical Trial Administration
Requisition ID
1805663301W