Johnson and Johnson Clinical Operations (JJCO) is recruiting for a(n) Associate Director, Innovative Methods and Design (global position).
Innovative Methods and Design is a novel function within JJCO, a unit accountable for strategic leadership and operational oversight of Clinical Operations cross enterprise. This new functional area is responsible for advising, catalyzing and driving innovative trial methodologies, such as hybrid trials using Real World Data (RWD) and developing related operational capabilities across sectors.
The Associate Director, Innovative Methods and Design will be responsible for set-up and execution of activities in the Innovative Methods and Design group in JJCO. This includes management of pilots and development of capabilities to enable execution of novel trial methodologies.
The Associate Director will lead a cross-functional team to run assigned pilot(s) and will use key partnerships to ensure a coordinated approach to pilot set-up, execution, management and reporting. Incumbent will generate standard methodologies and lessons learned from the assigned pilot(s), with the aim of insights generation and creation of evidence for scientific use and dissemination.
Incumbent will report into the Sr Director, Innovative Methods and Design
What are the Key Responsibilities?
• Leads complex cross-sector and cross-functional team(s), working effectively in a matrix.
• Provides critical input geared at developing strategy and clinical operations capability (process and systems) related to innovative clinical trial methodology.
• Drives development of pilot strategies and execution and collates lessons learned
• Accountable for delivery of assigned pilot(s) within agreed project budget/timelines/quality.
• Manages vendors and suppliers related to all pilots.
• Builds active networks with internal partners and external authorities to exchange learning, good practices and industry benchmarking.
• Bachelor’s degree or equivalent required, preferably in the Life Sciences, e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy. Advanced degree is a plus.
Experience and Skills:
• 8+ years’ experience in the pharmaceutical, medical devices or consumer industry in R&D or Medical Affairs, including exposure to Clinical Operations, Clinical Development teams/processes, Clinical trial methodologies and research involving use of Real-World Data.
• Demonstrated knowledge of clinical research (end-to-end) processes and relevant regulatory requirements.
• Passion for innovation and possesses knowledge of key issues and trends impacting all J&J sectors including RWD policies and patient-centered research
• Strong leadership skills, including influencing across matrix organization.
• Strong project and portfolio management skills.
• Strong global and written communication skills and the ability to communicate optimally across all levels of the organization.
• Proactive and willing to challenge the status quo and drive innovation.
• Knowledge and experience with Health Care Databases, Electronic Health Records and Real World Data sources is an asset
• Strategic thinking and ability to quickly analyze and structure problems.
Other relevant experiences and skills may be considered by the hiring manager when considering candidate eligibility.
Estimated international travel up to 10%.
Europe/Middle East/Africa-Netherlands, North America-Canada, Europe/Middle East/Africa-Italy, Europe/Middle East/Africa-Serbia, Europe/Middle East/Africa-Germany, Europe/Middle East/Africa-Spain, Europe/Middle East/Africa-France, Europe/Middle East/Africa-United Kingdom, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Spring House
Janssen Research & Development, LLC (6084)