J&J Family of Companies IT Senior Manager, Business Technology Leader, Clinical Development in La Jolla, California

Janssen Research & Development LLC, a Johnson & Johnson company, is recruiting for a IT Senior Manager, Clinical Business Technology Leader Clinical Development, a global role with location options in USA in Pennsylvania (Spring House or Malvern), New Jersey (Titusville or Raritan), La Jolla, CA or in Beerse Belgium. This position may require 10% to 20% domestic & international travel.

Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market – from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visit www.janssenpharmaceuticalsinc.com

KEY RESPONSIBILITIES

The Senior Manager, Business Technology Leader combines modern Information and Technology expertise with clinical and pharmaceutical R&D knowledge to transform the way information and technology are used in the way clinical trials are planned, designed, executed, and reported. Partnering with clinical research scientists on one hand, and IT solution services on the other, this role is accountable for identifying and bringing radical new ideas and technologies to new and innovative ways of working to digitalize drug development. The role will also take leadership in defining, planning, and initiating technology enabled business improvement initiatives that will deliver clear and measured step change in the business of drug development. This leader will be looked upon as both a functional and technical expert, who is passionate about improving the science of clinical research with the power of data and technology. The Senior Manager, Business Technology Leader for Clinical Development reports to the Senior Director, Business Technology Leader for Clinical Development and Innovation, in R&D Operations Business Technology (BT). S/he will connect with internal business partners and external experts to shape demand and resolve how to best support the business through most appropriate use of skills, tools, capabilities, and technology. The position will participate in strategic business planning with Global Clinical Development Operations partners and will lead business analysis activities and business risk assessments for newly identified technology opportunities. The position holder will partner effectively with the broader J&J Technology organization, including other Business Technology Leaders, Product Line organizations, Enterprise Product lines, Global Technology Services, and enterprise and solutions architects to design the solution and ensure effective integration of new systems and technologies in existing system landscapes. S/he will be responsible for all project management activities focused on establishing scope and project objectives, development of budget and capital appropriation requests, as well as meeting time and budget requirements, directing all project resources, and helping the business partner(s) realize the desired business goals for the project(s).

Responsibilities include: Information and Technology consultancy, business relationship management, and account management provided to Clinical Development Operations leaders; identify and analyze business needs; work with department members to ensure alignment on scope and requirements; create opportunities for innovation in process changes via technology enabled solutions; contribute to the strategic planning process and long-term direction for IT. The role holder is expected to work independently in formulating creative ideas and solutions on products, processes, and systems; assess proposed solutions and develop recommendations based on industry trends and benchmarking; maintain alignment with IT strategies and technology roadmaps. Furthermore, contribute to the business case development for proposed projects; build and maintain strong partnership with strategic technology providers; and contribute to budget development and portfolio monitoring within area.

Additional specific responsibilities include:

  • Develops and / or contributes to IT strategies and roadmaps based on Janssen business objectives around clinical trial management and execution, potentially including:

  • Clinical trial design and feasibility – leveraging historical clinical trial data and real-world evidence

  • Patient recruitment, engagement & retention in Clinical Studies

  • Investigator site selection & engagement in Clinical Studies

  • Data collection and analysis, including novel Mobile Health technology in Clinical Studies

  • Innovative technologies and their application in Clinical Studies (e.g. AI, Expert Systems, Blockchain, etc.)

  • Keep abreast of external environment and evaluate tools and solutions

  • Drives RFI/RFP processes and pilots as appropriate to evaluate relevant tools and capabilities

  • Partners in the implementation and service delivery of solutions with IT Product Line Owners, ensuring quality delivery of Clinical Development Operations projects and initiatives throughout the J&J system development life cycle:

  • Consulting with Business Partners to establish and drive requirements

  • Collaborates closely with Architecture to build roadmaps, ensure end to end process and data flow and evaluate potential technology partners

  • Influencing and negotiating scope and change management between project stakeholders and suppliers

  • Accountability in addressing project and / or service delivery escalations: Connect enabling teams such as the development centers, professional services support center, and other service-based teams, to ensure a positive overall offering delivery experience for customers.

  • Advises and influences senior management in Global Clinical Development Operations on the transformation and application of digital technologies, aligned to the overall R&D IT strategy

  • Assist in the continuous improvement of clinical development SOP’s and WI’s, as well as ensuring compliance with current and future regulations, policies, and standards

  • Builds superior skills within a strong overall team

Qualifications

Professional Experience:

  • Knowledge of Clinical Development data, standards, processes, capabilities and priorities - specifically where data and emerging technology can transform pharmaceutical innovation: the candidate would ideally also poses understanding of the overall pharmaceutical R&D lifecycle

  • A creative and innovative thinker with combined strong technical knowledge and strong communication and leadership skills

  • A driver of business value who follows rigorous IT portfolio management to ensure timely delivery of projects that achieve expected benefits

  • Strong understanding of current technology landscape in clinical research

  • A team player and leader, who has demonstrated consistent team leadership and coaching

  • Thrive in a rapidly changing technology and business environment

  • Strong interest in pharmaceutical drug development and clinical research, with a passion to learn and expand knowledge of clinical research challenges, processes, and regulations

Qualifications:

  • A minimum of a Bachelor’s degree and 5 years related experience in R&D related IT and/or informatics, preferably within a pharmaceutical setting OR a Master’s degree or a PhD and 3 years of related experience in R&D IT and/or informatics, preferably within a pharmaceutical setting.

  • Strong clinical research business process foundations, and a demonstrated capability to apply technology solutions in addressing complex, global business issues.

  • Experience managing consultant resources, and internal and external technical personnel in a fast-paced, complex, global project environment.

  • Demonstrated project and program management capability based on the successful completion of projects in global, cross-functional business areas, including management of budget/finances.

  • Demonstrated capability to develop, maintain, apply and influence data, application and technical architecture.

  • Strong communication and relationship building with key stakeholder.

  • Strong foundation in and a thorough understanding of: 1) methodologies for system design, development, and implementation; 2) business relationship management 3) IT system validation and regulatory requirements.

  • Informed on current and new technologies & their applicability to the business.

  • Must have experience working with at least one, but preferably multiple domains of clinical research in either an IT or clinical business role: study management, data management, statistical analysis and reporting, patient safety, or clinical project management.

  • The ability to work in cross functional teams and lead individuals with multidisciplinary backgrounds.

  • Up to 20% travel (domestic & international).

Primary Location

United States-Pennsylvania-Malvern

Other Locations

North America-United States-Pennsylvania-Spring House, North America-United States-California-La Jolla, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, North America-United States-New Jersey-Raritan, North America-United States-New Jersey-Titusville

Organization

Janssen Research & Development, LLC. (6084)

Job Function

Business Relationship Management

Requisition ID

00001CNK