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Director Functional Management Clinical Trial Management
Requisition ID: 1805630803W
‘Caring for the world, one person at a time’... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people.
Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
The Director, Clinical Trial Management (CTM) Functional Management will provide operational leadership to a team of CTM Functional Managers across one of more therapeutic areas, driving the effective coordination of study placement, start-up and execution in collaboration with country and central study teams. The role will also provide regional leadership for the CTM organization across one or more GCO regions. The director is a member of the CTM Leadership Team, GCDO Leadership Forum and extended member of the GCO Leadership Team.
He/she has overall accountability for CTM Functional Managers within the assigned therapeutic area(s) in the appropriate staffing and performance management of clinical trial managers to ensure that studies are carried out within agreed timelines and in line with the applicable SOPs and regulatory requirements. The position is responsible for Functional Manager staff development, project assignments and workload distribution. He/she ensures alignment of goals with organizational objectives and assigned trial objectives.
The role will ensure effective regional coordination of CTM functional activities and management of issue escalations within one or more assigned GCO regions through building and maintaining relationships with regional and country leadership roles. He/she will provide strategic input and engage with the head of CTM as well as country heads and regional VP(s) in defining and implementing long term strategy for the assigned region(s)/regional hubs.
The Director may act as the business owner for assigned processes and/or support continuous process improvements. He/she may act as the back-up to the Head of CTM.
This position directly influences departmental planning and strategy, resource management and global functional communications activities.
The role leads and/or participates in departmental and/or cross functional process improvement projects, departmental decision-making, recruitment, resource assessments, and end of year performance evaluations and provides an environment which encourages the company's credo, commitment to equal employment opportunity and the value of a diverse work force.
- Provide operational leadership of CTM Functional Managers in one or more therapeutic areas:
- Oversee Functional Managers to effectively lead the CTM teams in the execution of clinical trials according to required timelines and according to protocol, International Guidelines for Good Clinical Practice, international and national SOPs and local procedures and regulations.
- Ensure strong collaboration between the Functional Managers, CTM teams and the GCO regional and country teams is built in every trial, and that local as well as global perspectives are incorporated in the trial setup.
Oversee resource allocation for assigned TA portfolio(s). Ensure appropriate Functional Manager resources to support span of control. Oversee Functional Manager workload to ensure optimal utilization of resources and support for portfolio objectives.
Set operational objectives for the team in alignment with company, project team, departmental objectives.
Develop strong working relationships with key business partners, and create a culture of cross-functional collaboration between CTM Functional Managers and their teams
Works to build effective collaborations between CTM Functional Managers and their teams with Portfolio Delivery Operations teams, Quality Management, IDAR, Regulatory, Clinical Supply Chain, Q&C.
Aligns with the respective GCDO Operations Head and GCDO Program Leaders on resource allocation decisions and issue resolution.
Lead the effective collaboration between the CTM global organization and one or more GCO regions through building strong relationships with GCO cluster heads, regional VPs and country heads.
Collaborate with peer Directors Functional Management and CTM Head to ensure consistent and effective collaboration between the global CTM organization and all GCO regions.
Build a high performing team of Functional Managers through on-going development, performance management and coaching. Take ownership for ensuring a strong pipeline of leaders within the organization through the Succession Planning process, and foster employee engagement, inclusion and Credo Behaviors.
Lead the effective and timely resolution of issues escalated by Functional Manager, GCO regional leadership or other GCDO stakeholders.
Actively contribute to process improvements liaising with the various functions within GCDO, BRQC, and to continuously improve the clinical processes, systems and training.
Ensures staff are trained on procedures and systems associated with their assigned tasks. Performs administrative tasks associated with performance reviews, salary administration, and other personnel issues.
Decision making and problem solving:
Leads and participates in Global CTM organizational decision-making and assessment of complex organizational issues, in collaboration with the CTM management team.
Drives organizational performance, quality and efficiency in the areas of accountability through the assessment of complex organizational issues and processes and deploying judgment in the prioritization of innovation and continuous improvement opportunities.
Must be able to build effective and diverse networks of stakeholders within and outside of the organization to enable enhanced complex organizational issue resolution and drive continuous improvement.
Actively engages with external strategic partners, the external environment and the wider industry to continually monitor industry trends and current vendor relationships to identify and drive opportunities for enhanced partnerships.
Must be able to work with a high level of independence and be able to train/coach others with regard to teamwork, collaboration, streamlining processes, training and quality and compliance activities. Sets priorities and liaises with CTM management and GCDO functions as appropriate, regarding issues/workload.
The Director Functional Management (CTM) has a direct reporting line into the global Head of Clinical Trial Management and will have multiple CTM Functional Manager direct reports across one or more therapeutic areas.
- A minimum of a Bachelors Degree or equivalent is required.
- A minimum of 10 years experience in a medium to large scale matrix organization which includes applicable operational and compliance related field and/or equivalent time and experience in a related R&D area is required.
- Extensive line and people management experience.
- Requires a thorough knowledge of the drug development process, good knowledge of worldwide GxP compliance regulations, sound research and development practices, scientific and quality terminology, company quality assurance procedures and policies, high technical skills, and quality evaluation techniques.
- Experience of the overall drug development process
- Expert knowledge of FDA/ICH and country-specific regulations and guidelines related to clinical development
- Extensive line management experience including leading staff who have line management responsibilities
- Extensive knowledge of business processes and practices (i.e., SOPs governing clinical research activities)
- Experience in quality assurance activities
- Strong people management experience
- Experience with a wide range of computer and system applications
- Strong matrix leader and collaborator
- Highly committed to quality
- Excellent communicator, with excellent interpersonal skills and diplomacy
- Decision maker
- Flexible and persistent
- Excellent people management skills, with ability to select and motivate professional colleagues fitting the organization and lead leaders of people
- Proactive strategic thinker
- Ability to independently plan, organize, co-ordinate, manage and execute assigned tasks
Location: UK, US, Poland, Belgium or The Netherlands
This role may include up to 25% of travel.
What’s in it for you…?
“Caring for the world, one person at a time…”
As an employee we consider you as our most valuable asset. We take your career seriously.
As part of a global team in an innovative environment your development is key and our day-to-day responsibility.
Through e-university, on the job training, various projects and programs, we ensure your personal growth.
Our benefits make sure we care for you and your family now and in the future.
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Clinical Trial Coordination