Senior Director Global Clinical Operations Head of Growth Countries at Johnson & Johnson

The GCO EMEA Head of Growth Countries is accountable for the strategic and operational leadership of clinical research and development activities across South Africa (and the sub-Saharan Africa region), Israel and Turkey, in alignment with GCO and Global Development (GD) organisational objectives. The role will also have accountability for driving the longer-term strategy for building clinical site and clinical site network partnerships across the wider EMEA region. Operational accountabilities include ensuring optimal execution of all phases of clinical trials across the role’s geographical scope according to agreed goals, timelines and budgets and in compliance with relevant Standard Operating Procedures (SOPs), policies, Health Care Compliance (HCC) and local regulatory requirements. Strategic leadership accountabilities include driving the development of capabilities and shaping organisational structures across the role’s geographical scope to increase efficiency and productivity and support the optimal conduct of current and future clinical research projects. The role will also be accountable for developing a supportive framework to support countries with emerging and growing clinical research capabilities that may move into the Janssen core country clinical trial footprint in the future. The role is responsible for line management and development of Country Heads, Functional Managers and other GCO staff, as required, and leading and applying industry leading talent management best practices.

Principal Responsibilities

• Define and execute the long-term strategy for optimising the planning and execution of clinical research and development activities across the role’s geographical scope, in alignment with GCO and GD objectives, demonstrating strong leadership behaviours according to the J&J Leadership Imperatives and CREDO values.
• Ensure predictable planning and execution of operational objectives and fit for purpose monitoring of clinical trials through all phases (from feasibility to close-out) across the role’s geographical scope.
• Ensure adequate quality and compliance oversight across the role’s geographical scope including compliance to safety reporting requirements, ICH-GCP, relevant SOPs and agreed quality metrics. Ensure appropriate and timely issue escalation and reporting (suspicion) of fraud scientific/ethical misconduct and any health care compliance breach. Always ensure inspection-readiness.
• Lead the development, implementation and evolution of the talent management strategy across the role’s geographical scope and in alignment with GCO and GD talent strategies to ensure highly motivated and skilled leaders and teams to support the current and future business objectives. Lead the talent development and acquisition strategy and support staff hiring and development as required.
• Ensure alignment of goals and objectives for direct reports and the wider organisation with GD and GCO goals and objectives.
• Support Country Head direct reports in their role as point of contact (PoC) for Health Authority agencies for activities related to clinical operations.
• Support Country Head direct reports in their role as country legal representative for GCO related activities
• Management of functional budget across the role’s geographical scope in collaboration with Country Heads and in compliance with relevant financial processes including evaluating resource demand forecasts against supply.
• Ensure an efficient utilization of the flex resourcing model across the role’s geographical scope in collaboration with Country Heads, Strategic Partnerships and the external flex partners.
• Foster the development of strong cross-functional partnerships across the role’s geographical scope, including supporting strong partnerships with country(s) operating company stakeholders, to help ensure GCO, GD and wider organisational objectives. Actively support and champion Country Head participation in Local Operating Company Management Board and/or Regional Management Teams. Partner across R&D to support capability building for clinical trials in the sub-Saharan region of Africa.
• Active membership of, or strong partner for, regional and or global GCO leadership teams. Contributes to the development and execution of strategies in support of overall leadership team and broad GCO functional objectives. May lead capability and process improvement initiatives with scope and impact beyond role’s primary geographical responsibilities.
• Build strong partnerships in the wider GCO, GD and R&D organisations in support of efficient delivery of goals and objectives for the role’s geographical scope and in support of wider organisational objectives.
• Foster best practice sharing and a culture of innovation and continuous improvement across the role’s geographical scope, and the wider organisation, to drive new capability development in support of high quality, efficient and productive planning and execution of clinical research and development activities.
• Coordinate gathering insights and feedback across the role’s geographical scope to support optimal development and evaluation of new processes and standards to improve clinical trial planning and execution and enable the rollout and adoption of organizational changes, new processes, technologies and capabilities.
• Contribute to shaping the environment for clinical trials across the role’s geographical scope by supporting Country Head engagement with regulators, patient advocacy, pharmaceutical industry associations and other external stakeholders.
• Provide coaching or mentorship as needed.

Principal Relationship

• Primary Reporting Structure: Reports to GCO Regional Head/GCO Head.
• Primary interfaces: Country Heads and Functional Managers, Peer Regional Heads, key GCO functional leaders including those across Global Trial Co-ordination and Contract and Compliance Services.
• Other Internal Interfaces: R&D/Local Operating Company staff (including Medical Affairs, Government Affairs, Health Economics and Access groups), departments within and outside of GCO/GD, including, Portfolio Delivery Operations, Project Management Organisation (Feasibility Centre of Excellence), EBIS, IDAR, QS, BRQC, HCC, Strategic Partnerships and others as required.
• External Interfaces: Functional management of flex providers, Health Authorities, local pharma industry associations, investigational sites, local vendors and others as required.

Education And Experience

Qualifications

• Bachelor's degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy). Advanced degree in a scientific discipline and/or Master’s degree is preferred.
• Minimum of 10 years of clinical research experience acquired in pharmaceutical industry, CRO or investigational site.
• Excellent communication and leadership skills. Proven ability to foster team productivity and cohesiveness. Ability to manage complexity under pressure. Proven track record of people and project management. Strong in hiring, training, developing and evaluation of leaders and people managers. Strong decision-making and financial management skills. Flexibility to work in a rapidly changing environment with the appropriate sense of urgency. Experience in transforming organizations in response to business needs.
• Effective issue resolution and ability to generate and implement contingency plans for both productivity and quality issues when required. Excellent knowledge of drug development, clinical research operations and regulatory requirements including ICH-GCP, HCC and applicable regulations. Ability to synthesize and evaluate data generated from various reports and sources. Demonstrated skills in effective communication with various internal and external stakeholders (e.g. investigational sites, ethics committees, health authorities. etc.). Influential in improving the clinical research environment at a country level. Visionary leader who can shape the organizational culture to improve adoption of future state.
• Operates with limited supervision.
• Proficiency in English. Computer literacy. Strong interpersonal and negotiating skills. Excellent organizational skills and ability to collaborate and handle multiple priorities within a matrix environment. Perform activities in a timely and accurate manner.