Johnson & Johnson Careers
Pre-Clinical Development Leader
New Brunswick, New Jersey
Requisition ID: 5256180628
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Pre-Clinical Development Leader, located in New Brunswick, NJ, Boston, MA, Springhouse, PA, Skillman, NJ, Raritan, NJ or Titusville, NJ.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/ for more information.
The Pre-Clinical Development Leader will provide scientific and strategic leadership to the BARDA Development Project leading the preclinical studies for Biodefense, Oncology, and other potential indications.
• Leading the development and maintenance of the preclinical strategic plan as well as the operational project plans (activities, resource requirements, budget and timelines) for the program.
• Planning, implementation and supervision of studies to ensure study deliverables are met according to specified timelines, budgets, quality and resources.
• Working in close collaboration with internal and external stakeholders including project teams, research organizations, regulatory authorities and other stakeholders.
• Manages external service contracts and collaborations, including CRO activities and industry and academic collaborations for pre-clinical studies.
• Review and approve study reports, author or review and approve regulatory submissions from Pre-IND submission through NDA, including summary documents.
• Respond to regulatory requests relating to preclinical studies or data in close collaboration with Clinical, CMC, clinical pharmacology, clinical and regulatory functions.
• Work closely with Regulatory, Clinical, and Drug Safety to establish safety monitoring plans in clinical trials based on preclinical findings.
• Lead the integration of Safety, PK and PK/PD and efficacy assessments in close collaboration with functional experts.
• Represent the project at internal and external review committees, including Global Health Authority meetings.
• Leading an internal and/or external preclinical sub-team of functional experts to move the program forward.
• Identifying potential safety, PK, PK/PD and quality related issues impacting drug development, design and implement mitigation plans and guarantee the overall quality of the project.
• Leading the preparation of regulatory documents (i.e., IND, NDA, MAA, CTD and responses to regulatory agencies) prepared by the preclinical sub-team.
• Responsible for authoring or reviewing and updating preclinical sections in the Investigator Brochure and updating cross-functional teams on relevant new safety findings from pre-clinical studies.
• Keeping informed on the existing and evolving preclinical guidelines.
• PhD degree in Pharmaceutical Sciences, Pharmacology, Toxicology or confirmed equal experience, with a deep understanding of preclinical drug development is required.
• A minimum of 10 years of experience supporting preclinical development including coordination of IND/NDA/MAA/CTD filings and interacting with regulatory authorities is required.
• Organizational, planning, analytical skills and the leadership skills needed in the completion of deliverables to the Compound Development Team is required.
• Excellent partnering and decision-making skills, the ability to perform effectively in a constantly changing environment, to bring perspectives and approaches together in novel and unique ways, and create and suggest new ideas for projects/programs is strongly preferred.
• Track record of publications in peer reviewed journals required.
• Excellent oral and written communication skills are required.
• This position requires up to 30% travel, both domestic and international.
Johnson & 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.
United States-New Jersey-New Brunswick
Johnson & Johnson (6067)