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Senior Director, Trial Management Head (M/F) - Medical Affairs Operations - 2306142115WDescriptionAs the world's largest and most broadly based healthcare company, we impact more than a billion lives through the innovation happening at 260 companies located in 60 countries around the world. Teams from Johnson & Johnson’s Medtech are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals are using AI to discover lifesaving drugs. We redefine what it means to be a big company in today’s world.For our pharmaceutical sector, we are currently recruiting Senior Director, Trial Management Head (M/F) to join our Medical Affairs Operations team on a permanent contract.This role can be based in the US or in EMEA – ideally close to one of our J&J location.The Trial Management Head will provide strategic and operational leadership, functional management and people development for the Trial Operations (TO) group within the Delivery Unit, driving the allocation, development and training of resources to support the execution of the portfolio.He/she is responsible to ensure all associated resources are planned in accordance with the Global Development workforce management plan to assure the capabilities and experience levels of the staff meet the the specific needs of the Delivery Unit. To identify gaps and assure that staff are developed to fulfil those gaps.The role will be accountable to hire, onboard and train the resources needed to support the execution of the portfolio.The Trial Management group primarily consists of the Clinical Trial Leaders, Clinical Trial Managers and Clinical Trial Assistants - headed by functional managers – who are responsible for the global and/or regional coordination of clinical operations activities for all J&J Pharma R&D clinical trials, in the specific TA.The Trial Management Head is a member of the Senior Leadership Team (SLT) of the Delivery Unit (DU) and as such, is involved in strategic and operational management and decision-making within the DU.Major Duties & ResponsibilitiesProvide operational leadership over the TM group and the portfolio managed by the TM group:
Lead the TM organization so that project resource planning is completed.
That staff are hired, trained, and developed in accordance with JNJ standards and assure compliance with International Guidelines for Good Clinical Practice, international and national SOPs and local procedures and regulations.
Accountable for ensuring Trial Management Teams work in a harmonized, efficient and effective way towards customer satisfaction.
Ensure a strong connection to the country teams is built in every trial, and that local as well as global perspectives are incorporated in the trial setup.
Partners with key Delivery Unit stakeholders and creates a culture of cross-functional collaboration across all teams.
Work effectively with: all DAS & Delivery Operations leaders, GCO Regional Heads, other GD functions, business support groups like Quality Management and Clinical Supply Chain QM
Ensure Functional Managers and Directors align with the respective Clinical Delivery Leaders
Leads effective and timely resolution of cross-team issues with vendor performance and propose the right mitigations.Establishes and manages budget and resource allocation in the TO group. Oversee staff workload to ensure optimal utilization of resources.Sets strategic and operational objectives for their organization by identifying high impact opportunities across clinical operations and ensuring their alignment with overall DU and GD objectives. As well, provide leadership for the development and implementation of these innovative business practices and improved processes to the DU and GD.Build a high performing team 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.QualificationsEducation & ExperienceUniversity/college degree in a scientific discipline is required.A minimum 8-10 years of global business experience with progressive leadership roles, focused on clinical operations at a global scale, with a proven track record of people and project management.Expertise in the areas of drug development, clinical trial operations, and study start-up / planning (from initial concept to PED development) is required both from a central and a local perspective.Experience in both insourced as well as outsourced models in an assetDemonstrated experience working in cross-functional teams (50 people) and managing large projects - change management experience in driving complex, significant efforts to manage large-scale clinical trials.Effective leadership skills to manage a large global team, with proven ability to foster international team productivity and cohesiveness across roles and geographies / Ability to lead, inspire and influence a large, global team through a period of high change.Ability to drive a Credo-based culture, including a diverse and inclusive environment.Excellent communication skills and the innate flexibility to work in a rapidly growing and changing organization.Proven track record in organizing execution and getting results through leading others.Primary Location NA-US-New Jersey-TitusvilleOther Locations Europe/Middle East/Africa-United Kingdom-England-High Wycombe, NA-United States, Europe/Middle East/Africa-Switzerland-Basel-Country-Allschwil, Europe/Middle East/Africa-Switzerland-Zurich-Zurich, Europe/Middle East/AfricaOrganization Janssen Research & Development, LLC (6084)Travel Yes, 10 % of the TimeJob Function Clinical Trial AdministrationReq ID: 2306142115W
