CDTL THROMBOSIS EARLY DEVELOPMENT Job

Job description

CDTL THROMBOSIS EARLY DEVELOPMENT-2064150323DescriptionJanssen 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.
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The CDTL for early projects provides co-leadership to a cross-functional compound development team beginning at LO entry, and drives the development and execution of the compound strategy, working in close partnership with the Discovery Project Leader.
The essential functions for this position include: Works with functional area partners program (including clinical, regulatory, commercial, drug safety, PDMS) to develop and update overall strategy for target and compound, including any back-up;Works with commercial and clinical to complete and maintain the target product profile; 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 compound strategy decision-making by ensuring relevant research, analysis, and expertise is available, bringing in internal and external experts as needed; Works with clinical and clinical pharmacology (and MBDD, as appropriate) to assure clinical development plan is appropriately evolved to be delivered for CDP document at NME and further refined 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 compound 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.
QualificationsThis 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 required. Excellent communication and leadership skills and a strong track record of producing results in a matrix-based environment are required.
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J2W:LI NAPrimary Location:North America-United States-Pennsylvania-Spring HouseOrganization: Janssen Research & Development, LLC. (6084)Job Function: Clinical Research non-MDCertain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. EEO is the Law EEO is the Law GINA Supplement