Fortrea

Global CRO providing Phase I-IV trials

Senior Director - Clinical Network

Clinical Research OperationsConfirmed live in the last 24 hours

Full-timeTokyo, JapanNo salary listed

About the Job

Requirements

A university or college degree is required; life sciences is preferred, or certification in a related allied health profession from an appropriately accredited institution is accepted. Relevant equivalent experience may be considered instead of the education requirement.
Expert-level spoken, written, and reading proficiency in English and the local language is required.
Thorough knowledge of the drug development process is required.
Thorough knowledge of relevant standard operating procedures, International Council for Harmonisation guidelines, and Good Clinical Practice guidelines is required.
Ability to manage a team to ICH GCP, FDA, and ISO 14155 standards, including understanding local and regional regulatory requirements.
Ability to lead by example and encourage team members to be responsible and accountable for their conduct and performance.
Planning and organizational skills are required.
Ability to manage multiple competing priorities is required.
Communication, presentation, and negotiation skills, and the ability to conduct and lead meetings, are required.
Ability to proactively identify and mitigate delivery and customer satisfaction risks is required.
Ability to communicate effectively and deliver to customer needs is required.
Ability to work in a team under time and resource constraints is required.
Ability to work independently with minimal supervision is required.
Strong financial acumen is required.
At least 10 years of supervisory experience is required, including two years managing managers and one year leading a team or function.
At least four years of effectively managing customer relationships in a healthcare or clinical research setting is required.
Working knowledge and understanding of resource management, resource management tools, and team development are required.
Knowledge of human resources and employee performance management processes is required.
Ability to drive and a valid driver’s license are required as appropriate under country travel standards.

Responsibilities

Lead clinical operational activities and performance within assigned countries or delivery teams, with responsibility for customer connections and commercial activity.
Lead a team and oversee quality, resource management, supply assurance, productivity, utilization, financial delivery, talent retention, and talent development.
Maintain a network of country ambassadors with country expertise to support strategic growth, and represent the company to customers, sites, regulatory bodies, and internal stakeholders.
Lead effectively in a matrix organization, build internal stakeholder networks, and influence peers and other departments.
Set clear expectations, coach and mentor team members, communicate consistently, and lead in a complex environment.
Build and sustain a scalable organization, foster ownership and accountability, delegate for employee development, identify high performers, and support continuous learning.
Partner with the Clinical Delivery Center of Excellence, Project Delivery, customers, and other functions to meet organizational, customer, and project goals.
Attract, select, onboard, develop, and retain talent; strengthen the talent bench and succession planning.
Mentor junior colleagues in the Clinical Network team.
Represent Fortrea leadership to external parties and customers in assigned countries and regions.
Lead country and regional initiatives and participate in global initiatives; provide backup for next-level management duties as needed.
Provide country expertise and insight on clinical operations, regulatory requirements, and the clinical landscape to support effective and efficient delivery of projects and services.
Partner with Clinical Delivery Center of Excellence peers to deliver to customer and project specifications, within or below budget and on time, while maintaining quality.
Participate in internal project management reviews and customer meetings, and liaise with colleagues in other functions to support project and customer delivery.
Define strategies with global regulatory and project management teams for local regulatory matters and act as a contact for local regulatory authorities.
Use operational, financial, and quality metrics and dashboards to assess country performance and take proactive action.
Develop and implement short- and long-term strategies to improve operational efficiency, quality, and productivity using key performance and quality indicators.
Define and drive resourcing and development strategies, ensure talent supply to delivery teams, assign suitable employees to projects and customers, and maintain effective utilization.
Hold employees accountable for productivity, company and customer metrics, quality objectives, and customer contract terms.
Develop and promote standardized processes and tools aligned with policies and delivery practices to improve quality, efficiency, and productivity.
Oversee employee selection, training, development, performance management, and line manager performance in assigned countries.
Ensure employees and teams meet core role, project, and customer delivery directives and standards.
Align employee volume, competency, and experience with current and projected work demand.
Develop and manage country-specific hiring and retention plans aligned with company strategies and Clinical Delivery Center of Excellence requirements.
Lead and participate in training, onboarding, and talent development strategies with human resources, legal, recruiting, training, and delivery teams.
Work with delivery leads and stakeholders to evaluate quality risks and identify role- or customer-specific training needs.
Manage employee competency, career paths, and succession planning.
Address employee engagement survey results by implementing appropriate mitigation strategies.
Manage and resolve employee performance issues and trends.
Mobilize, motivate, and engage employees, encourage mutual support, and promote company culture standards.
Ensure employees meet quality standards and comply with standard operating procedures, applicable guidelines and policies, training, regulatory requirements, and role requirements.
Identify quality risks, coordinate early intervention and mitigation, and continually improve quality standards.
Oversee quality indicators, identify quality risk trends, and implement mitigation plans in assigned countries while supporting global initiatives.
Ensure team compliance with quality indicators, monitor quality standards, and oversee quality control processes in assigned countries.
Develop and execute country quality plans aligned with identified quality risks.
Lead and provide input to relevant standard operating procedures and standard plans and templates.
Ensure compliance with quality management system issue reporting and management.
Develop and manage corrective and preventive action plans at country level, and develop country, regional, and global mitigation and effectiveness checks.
Manage resources, utilization, budget spending, and delivery in line with project scope and profitability goals.
Maximize country or cluster operational profitability while meeting quality benchmarks and deliverables on time.
Develop and manage strategies to optimize financial performance and business volume, and explain functional productivity and profitability.
Identify and manage cost overruns, including headcount growth, and agree on savings strategies or remedies with delivery leads.
Manage billable hours and utilization, escalate outliers, recommend actions, and assist management with mitigation.
Manage expenses and non-billable spending, including manager span of control and billable-to-non-billable ratios, in line with company goals.
Identify business opportunities through proactive customer-stakeholder networking.
Partner with business development, strategic development, and operations delivery leads to identify and support local and regional growth opportunities.
Share business development opportunity information with other company functions.
Use country expertise to drive strategic growth.
Support requests for information, proposal development, and bid-defense meetings as a country or cluster expert, or as a Clinical Network representative, with minimal supervision.
Act as the primary contact for local or regional customers.
Support contracts and legal teams with statutory document preparation and signature as needed.
Perform other duties as assigned.
Travel 20–30% by plane, rail, and car as required, including overnight stays within the country or region and globally.
Work in an office-based or home-based environment, with office presence where required.

Desired Qualifications

A master’s degree or other advanced degree from an appropriately accredited institution.

Job Overview:

A key operational role within our matrix organization, accountable for the clinical operational activities and performance within an assigned group of countries or delivery team, with responsibilities for customer connections and commercial activity. Leading a team with overall accountability for quality oversight and management, resource management and assurance of supply, productivity, utilization and financial delivery, talent retention and development. Maintaining a network of country ambassadors with country expertise to drive strategic country growth, representing the company both internally and externally to customers, sites, and regulatory bodies. 1-10 Countries. Medium to high complexity country(ies). High regional and local customer connections. 10-15 Direct reports. greater than 350 Indirect reports.

Summary of Responsibilities:

Leadership:
Effective leader in a matrix organization and demonstrates ability to create a network of internal stakeholders, influence peers and other departments.
Effectively lead in a complex environment, set clear expectations, coach, and mentor for success, consistently communicate, and connect.
Leads by example in building and sustaining a scalable organization; creates a forward looking culture of ownership and accountability; delegates for development and growth; identifies and sets up high performers for success; fosters a continuous learning environment.
Partnering closely with Clinical Delivery Center of Excellence (CoE) and Project Delivery (PD), Customers and other functions driving the organization towards internal, customer and project established goals
An inspiring leader that attracts, selects, on-boards, develops and retains high performing talent; strengthens and deepens talent bench and succession planning.
Provides mentorship to more junior colleagues to nurture professional growth of the Clinical Network team.
Represent Fortrea Leadership to external parties and customers within the country(ies) of responsibility and region.
Lead country and regional initiatives and participate in global initiatives.
May act as back-up for the next level management duties.
Operational Excellence:
Accountable for country expertise network proactively providing clinical expertise and insight within assigned country(ies), to advise on regulatory requirements and clinical landscape to ensure most effective and efficient delivery of global projects and services.
Partner with Clinical Delivery CoE peers to deliver to customer and /or project team specifications; within or below budget, on time while ensuring the highest level of quality.
Participate in internal project management review and customer calls/meetings, and liaise with equivalent colleagues in other functions, to ensure support to project and customer delivery.
Define strategies with the global regulatory group and the project management teams in managing local regulatory matters, acting as point of contact for local regulatory authorities.
Uses established operational, financial and quality metrics and reporting dashboards to assess overall country(ies) health and proactively take action where necessary.
Define and implement short-term and long-term strategies to improve operational efficiency, quality and productivity across assigned country(ies) through Key Performance Indicators (KPIs) and Key Quality Indicators (KQIs).
Define and drive department resourcing and development strategy with assurance of supply to Clinical Delivery CoE teams, ensuring the right level talent are assigned to the right project and/or customers at the right time; ensure that the talent is fully utilized.
Hold employees within the area of responsibility accountable for compliance to applicable productivity, company, and customer KPI’s, quality metrics and/or dashboard objectives, customer contract terms.
Partner to develop and drive the use of standardized processes and tools in alignment with associated policies and delivery practices to ensure quality, efficiency, and productivity.
Talent Management - Selection, Onboarding, Training, Development, Deployment and Retention (20%):
Accountable for selection, training, development, and performance management of employees in assigned country(ies).
Accountable for developing high performing employees, ensuring employee and teams meet, core role, project and customer delivery directives and standards.
Accountable for Line Manager performance in assigned country(ies).
Accountable for resource strategy and management aligning employee volume, competency, and experience to current and projected work demand for assigned country(ies).
Develop and actively manage country specific hiring and retention plans aligned to companywide strategies and Clinical Delivery CoE requirements.
Identify, lead and participate in training, onboarding or talent development strategies for the Clinical Network, partnering with other functions HR, legal, Recruitment, Training, Delivery CoE.
Partner with Clinical Delivery CoE leads, other internal and external stakeholders, evaluation of quality risk trends to identify role and/or customer specific training needs.
Responsible for development and management of employee competency , facilitated career paths and proactive succession planning.
Ensure high level of employee engagement by addressing employee engagement survey results with implementing appropriate and effective mitigation strategies.
Responsible for appropriate management and resolution of performance issues and trends in assigned country(ies).
Mobilize, motivate, and engage employees, encourage mutual support, and drive adoption of company culture standards.
Quality (10%):
Ensure that assigned employee works to highest quality standards in compliance with current SOPs, relevant guidelines/policies, training compliance, regulatory and role requirements.
Proactively work to identify quality risks, partnering with all stakeholders for early intervention and mitigation, continually raising the quality standards in assigned country(ies).
Accountable for oversight and management of KQIs, identifying quality risk trends and implementing risk mitigation plans in assigned countries and supporting global initiatives.
Accountable for team compliance with KQIs, monitoring quality standards and monitoring Quality Control process in assigned countries.
Accountable for the development and execution of country quality plans aligned to identified quality risks.
Lead and provide input to relevant SOPs and standard plans/templates.
Accountable for compliance with QMS issue reporting and management.
Responsible for CAPA development and management at the country level and development of country/regional/global mitigation and effectiveness checks.
Budget and Finance (30%):
Accountable for resource and utilization management, budget spend and delivery aligned to project scope and profitability goals in assigned countries.
Drive maximization of the profitability of operation in assigned country(ies) and/or clusters ensuring quality benchmarks and deliverables are met on time.
Lead, and manage strategies to optimize financial performance and volume in assigned country(ies). Influence and explain the overall productivity and profitability of the functional business units.
Proactively identify and manage cost overruns, including headcount growth. Propose and agree with relevant Clinical Delivery CoE leads strategies for delivering savings or remedies for issues observed in assigned countries.
Responsible and accountable for billable hours and associated utilization in the area of responsibility for assigned country(ies). Escalate outliers, provide recommendations, and take necessarily actions assisting the management team with mitigations.
Accountable for expense management and Non Billable spend, including line manager span of control and Non Billable/Billable ratio aligned to company goals.
Commercial and Growth (30%):
Responsible for identifying business opportunities within country, through proactive networking with customer stakeholders.
Proactively partner with BD, SDG and Operation Delivery leads to identify and support local and regional opportunities to grow the business in assigned country(ies) and/or region.
Actively network and share business development opportunity information with other Fortrea functions.
Provide country expertise to proactively drive strategic growth in assigned country(ies).
Support RFI response, proposal development and/or bid-defense meetings as an expert of their country or cluster of countries, or Clinical Network organization with minimal supervision.
Represent main point of contact for local or regional customers.
Support Contracts and Legal Budget for statutory document preparation and signature as needed.
All other duties as needed or assigned.

Qualifications (Minimum Required):

Education level: University/college degree – life sciences preferred or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technician).
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Expert level of English and local language required; speaking, writing, reading.
Thorough knowledge of drug development process.
Thorough knowledge of relevant SOPs, ICH and GCP guidelines.
Ability to manage a team to ICH GCP/FDA/ISO14155 standards, including an understanding of local and regional regulatory requirements.
Demonstrated ability to lead by example and to encourage team member to be responsible and accountable for their conduct and performance.
Excellent planning and organizational skills.
Demonstrated ability to successfully manage multiple competing priorities.
Excellent communication, presentation and negotiation skills and ability to conduct and lead meetings.
Demonstrated ability to proactively identify and mitigate delivery and customer satisfaction risks.
Demonstrated ability to effectively communicate and deliver to customer needs.
Ability to work in a team under time and resource constraints.
Ability to work independently with minimal supervision.
Strong financial acumen.

Experience (Minimum Required):

Minimum of 10 (ten) years supervisory experience, including 2 (two) years of managing managers, and 1 (one) year leading a team or function with 4 (four) years experience of effectively managing customer relationship in a healthcare or clinical research setting.
Working knowledge and understanding of resource management, tools, and team development.
Knowledge of human resource and employee performance management process.

Preferred Qualifications Include:

Education level: Masters or other advanced degree from an appropriately accredited institution.

Physical Demands/Work Environment:

Ability to drive and have a valid driver’s license as appropriate per country travel standards.
20-30% travel by plane, rail and car as required with overnight stays within country/region and global.
Office based or home-based environment: Fortrea office presence expected where required.

Learn more about our EEO & Accommodations request here.

About the Company

Fortrea

Global CRO providing Phase I-IV trials

Fortrea is a global contract research organization that provides clinical development services for the life sciences industry. It offers full service, functional service, and hybrid outsourcing models across Phase I–IV trials, clinical pharmacology, and consulting, serving biotech, biopharma, medical devices, and diagnostics. Its work is delivered through a network of investigators and specialized teams in approximately 100 countries, supporting trial design, execution, data management, and regulatory compliance. Fortrea’s approach combines its legacy experience from Covance and Labcorp with a pureplay CRO model to deliver fit-for-purpose solutions and agile project delivery. This positions it to manage trials across more than 20 therapeutic areas with scientific rigor and operational excellence. The company aims to bring predictability to clinical trial execution and help clients turn research ideas into real-world outcomes.

Company size: 10,001+
Company stage: IPO
Headquarters: Winston-Salem, NC
Founded: 2023

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