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Senior Director, Compound Development Team Leader Rheumatology
Johnson & Johnson
Spring House, PA, United States
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Senior Director, Compound Development Team Leader Rheumatology DAS
Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Compound Development Team Leader for Early Projects (eCDTL) to be located in Spring House, PA.
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, oncology, infectious disease, diabetes, cardiovascular disease, metabolic disorders, immunologic disorders, and reproductive medicine.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The CDTL for early projects provides co-leadership to a cross-functional compound development team beginning at Lead Optimization entry, and drives the development and execution of the compound strategy, working in close partnership with the Discovery Project Leader. The CDTL becomes the sole project team leader at New Molecular Entity Designation.
The essential functions for this position include:
• Works with functional area partners (including clinical, regulatory, commercial, drug safety, PDMS) to develop and adapt a Development strategy and plan for the asset and target.;
• Works with commercial and clinical to create and adapt the target product profile as new information and insights are gained;
• Responsible for assuring alignment with Leadership and executing on feedback with regard to GO/NO GO decisions, timelines, key studies, resource allocations and budgets, valuations and prioritization.
• Actively contributes to asset decision-making by ensuring relevant research, analyses, and expertise are available, bringing in internal and external experts as needed;
• Works with clinical and clinical pharmacology to assure clinical development plan reflects strategic intent at NME and adapted for FIH and Ph2a;
• Works with biomarker group and Discovery team to assure translational biomarker strategy is developed and implemented;
• Assembles and leads an early CDT (eCDT) with representation from appropriate functional partners, for the creation of a Development Plan that provides a thorough and clear asset strategy integrating input from all functional areas, identifying key development issues and the strategic approach to each, with associated timelines and budgets, offering clarity on alternative pathways and tradeoffs considered;
• Responsible for working with functional partners and Discovery Project Team Leader to identify key development issues (safety, formulation, structure-based, ADME, etc.) and develop and implement appropriate strategy in support of NME and Phase 1 transition;
• Challenges functional representatives to ensure that all issues and questions are being addressed, and that functional area input into strategy is adequate to meet the needs of the compound; leads CDT problem solving and applies decision-making tools and techniques. Drives CDT to make effective and efficient decisions;
• Leads the development team in assuring timely implementation of the compound strategy; Focuses on pipeline value rather than only project value – can balance role as team leader with commitment to maximizing portfolio value – willing to support GO decisions and appropriately come to NO GO decisions;
• Builds team effectiveness, and leads the development team/eCDT to achieve its goals through the networks of people/functions represented on the team. When necessary, negotiates with function heads on functional deliverables;
• Accountable for overall budget and project plan deliverables;
• Leads the communication of strategy, issues, and plans to the TA Review Board, and senior management committees;
• Builds and maintains team effectiveness and satisfaction; and Works with functional management to secure the required resources for project success, influence optimal team composition, align goals and objectives with CDT members, coach and guide CDT members, provide input for performance evaluation of CDT members.
Qualifications
Requirements:
• This position requires an Advanced Degree (PhD or MD) with >10 years' experience in a leadership role as part of a research-driven pharmaceutical company preferred.
• Experience in leading clinical development programs in CV therapeutic areas is required.
• Solid understanding of and involvement in the entire drug development process is required.
• Proven ability to work cross-functionally with interdisciplinary teams to access and optimize resources for development programs and experience working in a matrix organization is required.
• Business oriented; capability of managing resources and budgets with proven record of leading projects through successful transition from Discovery to Early Development and advancement of projects through preclinical and clinical development to Phase 2b within the therapeutic area is preferred.
• Creating a scientific vision for a transformational medicine with a linked development plan is required.
• Excellent communication of that vision and plan and matrix leadership skills are required.