Principal Portfolio Lead - Clinical Programming

About Johnson & Johnson Innovative Medicine

Johnson & Johnson Innovative Medicine is dedicated to the research, development, and commercialization of cutting-edge pharmaceutical products. Our work spans critical therapeutic areas including oncology, immunology, neuroscience, cardiovascular, and metabolic diseases. We are driven by a commitment to innovation and patient-focused solutions, utilizing advanced scientific approaches to create transformative medicines that enhance global health outcomes.

At Johnson & Johnson, we believe that health is fundamental. Our strength in healthcare innovation enables us to envision and build a world where serious diseases are prevented, treated, and cured. We aim for smarter, less invasive treatments and personalized solutions. Through our combined expertise in Innovative Medicine and MedTech, we are uniquely positioned to drive innovation across the healthcare spectrum, delivering today's breakthroughs for tomorrow's health needs and making a profound impact on humanity's well-being.

Job Summary

The Principal Portfolio Lead - Clinical Programming is a senior role requiring expert knowledge of programming strategies, methodologies, processes, technologies, industry standards, complex data structures, and analysis/reporting solutions. This position demands strong project and people leadership capabilities to effectively guide and oversee programming activities across teams, ensuring adherence to company and departmental procedures. As a portfolio leader, this individual will shape the programming strategy for a substantial portfolio within a specific disease area or delivery unit, taking accountability for operational oversight and the successful planning and execution of programming tasks for their assigned portfolio. They will liaunt with Delivery Unit Leaders at the program level, providing regular updates, managing risks and issues, and utilizing appropriate escalation channels. This role directly manages at least three direct reports and provides functional and/or matrix leadership to departmental staff, including recruitment, onboarding, performance management, and talent development, fostering an inclusive and diverse work environment. This position is crucial for the growth of C&SP and contributes to organizational effectiveness, transparency, and communication, directly supporting the J&J IM R&D portfolio through leadership in clinical development and strategic innovation.

Key Responsibilities

• As Project Leader: Drive the strategy, planning, execution, and completion of all programming activities and deliverables within the assigned scope, ensuring quality, compliance, consistency, and efficiency. Proactively manage resource demand, allocation, and utilization to meet current and future business needs. Maintain functional planning systems effectively and forecast needs for potential in-licensing and acquisitions. Independently manage issue escalations through appropriate channels. Collaborate with cross-functional teams and external partners on programming deliverables for co-development programs and define data integration strategies. Ensure training compliance and skill development for assigned personnel. Contribute to the development of functional vendor contracts and oversee vendor delivery against milestones and scope. Act as the primary contact for sourcing providers, establishing strategic partnerships. Drive the enhancement of functional, technical, and scientific capabilities within C&SP and promote best practices. Lead programming aspects of regulatory inspections and internal audits, ensuring real-time inspection readiness. Provide input to submission strategies for regulatory agencies and ensure programming deliverables are complete and compliant.
• As People Leader: Attract and retain top talent, manage performance proactively, and support talent development and succession planning. Ensure organizational effectiveness, transparency, and communication. Mentor and coach programming team members. Oversee work allocation, providing guidance and support. Manage local administration and decision-making for assigned personnel.
• As Matrix Leader: Identify opportunities and drive solutions to enhance efficiency and knowledge-sharing across programs, value streams, and the department. Serve as a departmental resource for process and technical expertise. Stay updated on industry trends and policies related to Programming. Lead departmental innovation and process improvement projects, contributing programming expertise to cross-functional initiatives as needed. Provide strategic direction within Delivery Unit initiatives and projects. Act as a programming expert and influencer in internal and external workgroups.
• Clinical Programming Oversight: Supervise the design, development, validation, management, and maintenance of clinical databases in accordance with established standards.

Additional Information

The company fosters an inclusive work environment where every individual is valued and respected for their diversity and dignity. We recognize and reward the merit of our employees.