Senior Director Head Digital Health Coe

This position leads the Digital Health Center of Excellence (DH CoE) within the Enabling Business Information Solutions (EBIS) team in Global Development (GD). This leader will support the ongoing transition to a Digital First approach for Janssen R&D (JRD) trials This person will work in close collaboration with relevant partners to shape and implement Digital Health (DH) capabilities, including building vital skill sets in the area. The person in this role will demonstrate end to end (E2E) thinking, digital savvy, understanding of external trends, and ensure proper linkages to DH strategies for clinical trials. **Clinical Study Operations**: - DH Solutions including, but not limited to Digital Health platforms, Electronic Clinical Outcomes Assessment (eCOA), Electronic Informed Consent Forms (eICF), Actigraphy, telemedicine, "smart" technologies, Wearables and Devices used in clinical trials - Central ECG and Imaging - Central Services related to translations, licensing, printing/paper COA (where applicable), as well as processes, organizational change management, communication and training, lessons learned, and best practices **Digital Health Solutions**: Ensures system validation, supplier oversight, operational strategy and framework, driving proactive solutions, understanding of portfolio needs for scaling up and operationalizing new technologies in JRD clinical trials Leads the team which provides JRD with a comprehensive operational framework for DH technologies in clinical trials to ensure: - Technology & Operational expertise is provided for a seamless and positive trial experience - High quality and timely delivery of clinical data - Fit-for-purpose technologies are implemented - Thought leadership across industry - Future clinical technology needs and opportunities are proactively assessed, in collaboration with internal and external partners **Principal Responsibilities**: - **Operationalize DH Capabilities in clinical trials**:Accountability for: Overall operational oversight of end-to-end processes for DH capabilities in JRD clinical trials, including internal and vendor key performance indicators; Timely resolution of issues raised by study/program teams and supplier-specific issues; Lessons learned built into study design - **Leadership**: Lead and develop an impactful, global, diverse team and to build industry-leading DH capabilities - **Focus on Continuous Improvement**: Build a continuous improvement and innovation culture to optimize the participant and site user experience, as well as impacted GD functions and internal and external partners. - Support **benchmarking **within and outside Janssen to identify and facilitate knowledge sharing across clinical teams and external partners. Continually assess new emerging technologies to optimize operational efficiencies. - **J&J Cross-Sector**:The job holder will provide expertise and leverage JRD investments related to DH capabilities across the other sectors as aligned with Johnson & Johnson Clinical Operations (JJCO) goals. Additionally, this leader promotes learning from DH approaches from other J&J sectors into JRD. **Principal Relationships**: - Internal - Global Development (GD), Therapeutic Areas (TAs), IT, Procurement, Legal, Commercial, Quality, Privacy, Security - External - Vendors, Industry **Qualifications** **Education and Experience Requirements**: - Bachelor’s degree required; advanced degree preferred - Recent experience leading leaders and global teams, with special focus in developing talent, is required - Confirmed experience (preferably 10+ years) in clinical trial execution with a Pharmaceutical, Medical Device company and/or a Clinical Research Organization (CRO) is required - Technical expertise, preferably in clinical trial operations, with significant experience in diverse and complex business processes and associated system infrastructures is required - Experience with DH technologies and related vendors - Confirmed experience of successful influencing across organizational boundaries is required - Demonstrated ability to build strategic working relationships and ability to lead and facilitate change - Good understanding of the therapeutic areas where Janssen is involved is required - Must work well in a dynamic environment, prioritize and respond to changing needs of the business **Other**: - Ability to travel up to 20% of time (Domestic/International) is required Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. **Primary Location** United States-Pennsylvania-Wayne-955/965 Chesterbrook Blvd **Other Locations** Europe/Middle East/Africa-Switzerland, United States-New Jersey-Raritan, United Kingd