The Senior Director, Product Development Clinical Leader (PDCL) role is responsible and accountable for the oversight of the Scientific and Clinical Development strategy across indications for assigned Compound Development Team (CDT) asset(s) at Janssen. This position is a Core member of the Compound Development Team (CDT) and in collaboration with key CDT functions, including Translational Medicine, Late Phase Clinical Development, GCSO, and other key functions, the PDCL is accountable for developing the overall clinical development strategy for assigned programs, including oversight of the design, implementation and reporting of programs in targeted disease states. The successful candidate will have exceptional clinical development, direct and indirect-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 on the Core and Extended Compound Development Teams, Core Membership on the Safety Management Team and other product oversight teams as the molecule responsible physician (MRP), accountability for clinical program reviews in the broader Janssen R&D structure, and overall strategy and execution of clinical development programs through product licensing. This role may also have substantial responsible for defining Development approaches for licensing/Business Development activities.
• Collaborate with Disease Area Strongholds (DASs), Pathway Strongholds (PASs), as well as Core and Extended CDT functions that may include Translational Science and Medicine, Late Clinical Development, Discovery, Clinical Pharmacology, Medical Affairs and Commercial, and Business Development to develop and oversee delivery of a comprehensive clinical development strategy.
• Indirectly lead a team of physicians and scientists who design, implement and report early and late-stage clinical trials in disease targets delivering to the compound/product strategy.
• Accountable for oversight and strategic direction of clinical portions of regulatory submissions, including licensing applications and other regulatory submissions.
• Deliver innovative, fit-for-purpose and transformational development strategies that address high unmet need for the CDT asset(s). This includes next-generation combination regimens to achieve transformative levels of efficacy.
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, leading directly and indirectly
• Ability to lead through delegation and work collaboratively across diverse teams
• 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 required. Extensive clinical development experience, preferably in more than one disease area, 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, lead through delegation, and implement and maintain high standards of research conduct
• Exceptional communication skills and leadership experience in clinical 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)