Senior Director, Clinical Research - Gatroenterology
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The Head of GI Development position forms part of the Senior Management structure of the Immunology Development Team at Janssen. This role is responsible and accountable for excellence in Clinical Science and Late GI Clinical Development within the Therapeutic Area. The Head of GI Development is accountable for the design, implementation and reporting of all Late-stage Phase II and III clinical trials development in Janssen’s Immunology portfolio. The successful candidate will have exceptional clinical development, functional-leadership and communications skills as well as a high degree of curiosity, innovation, entrepreneurship and a keen sense of patient unmet need. Responsibilities will include: membership in the Immunology Development Leadership Team, accountability for GI late phase program reviews in the broader Janssen R&D structure, and overall strategy and execution for all Late-stage GI clinical development programs through product licensing. This role also has substantial responsible for defining Late Stage Development approaches for licensing/Business Development activities.
• Lead a team of approximately 15 physicians and scientists who design, implement and report all late-stage phase II and III Immunology GI clinical trials. Accountable for delivery of regulatory submissions, including oversight of the preparation of clinical portions of Agency licensing applications and other regulatory submissions.
• Collaborate with Disease Area Strongholds (DASs), Pathway Strongholds (PASs), Discovery, Clinical Pharmacology, Medical Affairs and Commercial, and Business Development to deliver all late stage GI development matters and identify external opportunities and platforms required for next generation Immunology products.
• Deliver innovative, fit-for-purpose and transformational development strategies that address high unmet needs for all Immunology assets in late phase clinical development. This includes next-generation combination regimens to achieve transformative levels of efficacy.
• Is an integral/core member of the Immunology Development organization through membership on the Development leader team (DLT) and will contribute leadership and innovation with a “one portfolio high performing team” mindset as well as instill a culture of collaboration and rigor based on cutting edge methods and practices.
• Contributes to Immunology Development functional organization as a member of the Development Leadership team managing the GI Development talent strategy, driving operational excellence and efficiency, and drive key innovation initiatives
General Leadership Expectations
• Effective collaboration and implementation of core Immunology TA strategies with a one-team, one-portfolio mindset
• Strong capacity to work in a matrix environment and lead through ambiguity
• Outstanding visionary, strategic, communication and entrepreneurial skills
• Develop and maintain a strong external network including credible relationships with scientific leaders, key clinical opinion leaders, and regulatory officials as needed to advance the Immunology portfolio.
• Develop and maintain strong internal network with cross-functional groups required to operationalize and drive portfolio progression
• Represent both Janssen and the Immunology TA in a professional manner internally and externally
• MD, or MD/PhD is ideal. GI expertise preferred. Late stage development experience is essential.
• At least 10 years of relevant experience in drug development or equivalent
• Candidates should possess significant experience in clinical application of approaches to the treatment of immune diseases and a strong passion to drive programs into diverse indications, based on scientific rationale and unmet medical needs
• Broad understanding of drug development is critical with ability to drive innovation in drug development and ability to supervise, implement, and maintain high standards of research conduct
• Exceptional communication skills and leadership experience in drug discovery and/or early development to communicate goals and deliverables to senior management and governance committees through J&J
United States-Pennsylvania-Spring House-
Janssen Research & Development, LLC (6084)
Clinical Research MD