J&J Family of Companies Global Head, Clinical Operations Solutions in Horsham, Pennsylvania
Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Global Head, Clinical Operations Solutions. This position can be located in Spring House, PA; Horsham, PA; Malvern, PA; Titusville NJ; Raritan, NJ; High Wycombe or Beerse, Belgium.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
The Enabling Business Information Systems (EBIS) group is responsible for supporting the process and technology needs for Global Clinical Development Operations (GCDO) covering global clinical operations, medical affairs operations, portfolio delivery operations, data management, risk-management and central monitoring, statistical programming, regulatory medical writing and Investigator Patient Engagement.
The Global Head (Senior Director), Clinical Operations Solutions will have the overall responsibility to maintain and optimize the performance of Clinical Operations Solutions supporting GCDO deliver the Janssen R&D and Medical Affairs portfolios. This includes partnering in strategy definition as well as implementing, maintaining and continuously improving key focus areas such as:
Feasibility Solutions covering capabilities to support and enhance clinical protocol and site feasibility aligned with business objectives.
Site Initiation Solutions to optimize the performance of the site start-up process.
Clinical Trial Management Systems (CTM) covering capabilities to configure, maintain and enhance the management of clinical trials covering clinical program/project management, trial and site planning, site and subject management, study management, study financial management and clinical trial performance and reporting.
Global Tracking Solutions supporting pre-approval access and compassionate usage programs run by Janssen for non-marketed products.
Trial Master File (TMF) Solutions covering the collection of essential documents to record how obligations related to clinical trial study conduct and quality have been fulfilled.
Clinical Trial Portal Solutions facilitating recruitment and training of investigators and site staff including electronic exchange of information and documentation during the life-cycle of a clinical study.
Issue Management Solutions covering collation, triage, closeout, tracking and proactive elimination of issues.
User Management Solutions covering consolidated support for Clinical SAAS and internal system user management through partnering.
Standardized Validation approaches for all Clinical Systems - both clinical data and clinical operations inclusive of reporting and analytics.
Standardized Training support for all Clinical Systems - both clinical data and clinical operations inclusive of reporting and analytics.
Accountable for clinical operations systems inspection readiness and provide expertise as necessary for FDA and other health authority inspections
Lead initiatives to yield faster and more effective incident management, efficient change management services and will optimize the number of systems interactions and handoffs ensuring a positive end user experience.
Create and drive a continuous improvement framework with respect to clinical operations systems deployment, life cycle management and enhancements supported by greater partnerships with suppliers, Clinical Research Organization (CRO) partners and industry user groups.
Work with Business Partners, EBIS, IT and Finance to coordinate the business planning and prioritization process related to clinical solutions.
Set strategies aligned with business needs and optimizing the clinical operations systems infrastructure across GCDO by working with GCDO Functions, EBIS teams, GCDO IT, external partners and vendors.
Optimize user management, content management, performance management and lifecycle management associated with all clinical operations systems for GCDO.
Support key processes for clinical operations systems, such as: trial conceptualization, startup, execution and closeout. Clinical Operations Solutions include, but are not limited to: Protocol and Site Feasibility, CTM Systems, TMF, Filing and Archiving, Clinical Trial Portals and associated Site Training capabilities, System User Management, System Validation and System Training.
Manage and prioritize clinical operations systems deployment to maximize value for GCDO.
Lead the process for removing obsolete and legacy clinical operations systems across GCDO to streamline and align all platforms and systems.
Lead, manage and develop a high functioning diverse team and to build a department to enable industry-leading Clinical Operations Solutions, with a focus on delivering value for stakeholders.
Create a continuous improvement and innovation culture with respect to the current and future Clinical Operations Solutions to optimize the user experience across GCDO and with internal and external partners.
Create and connect with an external benchmarking network facilitating the distillation of best practices related to Clinical Operations Solutions from leading organizations externally whilst also identifying best practices from internal teams within Johnson & Johnson from different sectors.
Provide expertise and leverage current Janssen investments related to Clinical Operations Solutions across the other sectors as appropriate aligned with Johnson & Johnson Clinical Operations goals. Ensure that best practices in the area of Clinical Operations Solutions from other sectors are leveraged maximally in Janssen.
Contribute to long term strategy and the successful execution of annual goals and objectives of (EBIS) in line with GCDO imperatives. Provide regular updates and insights to the EBIS and GCDO leadership team of the status of Clinical Operations Solutions, highlighting operational or technical roadblocks and proposing potential solutions.
A minimum of a Bachelor’s is required, preferably in Computer Science, Science, Engineering, or a related discipline. Master’s degree is preferred.
A minimum of 15 years of relevant Pharmaceutical/Healthcare experience, specifically in the Clinical Trial space, working at the interface between systems and business, is required.
A minimum of 5 years of experience leading teams at a senior management level is required.
Experience leading individuals, leaders and teams, with a proven track record in developing talent, is required.
Technical expertise with significant experience gained through working with diverse and complex business processes and associated systems infrastructures is required.
Experience running clinical trial management systems is required.
Experience with feasibility of systems and associated processes, site initiation, CTM Systems and TMF Systems required.
Proven matrix leadership experience in a global environment is required.
Experience in pharmaceutical clinical operations is preferred.
Proven ability to translate and influence business requirements against existing Clinical Operations Solutions capabilities is required.
Proven ability to identify and remediate capability challenges within the team is required.
Must have excellent communication skills
Must have strong influencing and negotiating skills.
This position will require up to 30% domestic and international travel.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
United States-New Jersey-Raritan
Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States-Pennsylvania-Horsham, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Malvern
Janssen Research & Development, LLC. (6084)
Clinical Trial Administration