VP Clinical and Medical Affairs Posted November 12, 2009 10 Years Experience in Clinical Medicine Minimum 5 years in Pharmaceutical Warren, NJ

JOB DESCRIPTION: Responsible for medical, clinical and preclinical organization and development of cellular therapeutic products within divisions (in partnership with leadership team). Provide direction oversight for all preclinical initiatives. Responsible for strategic oversight and development of Phase I-IIIb initiatives. Responsible to plan, design, develop, monitor, oversee and lead Phases I through IIIB clinical programs. Responsible as thought leader in the development of new and innovative strategies related to regulatory and clinical use of new and exising products. Will provide input to potential in-licensing technologies Responsible for managing all regulatory activities. Ensures timely preparation of organized and scientifically valid submissions Develops and administers budgets, schedules, and performance requirements Act as a liaison to Corporate for medical, clinical, pre-clinical, and groups Review and approve all medical policies, processes and procedures Review document and perform corrective action for post transplant outcomes (LifebankUSA) Establish adverse outcomes policies and procedures (in conjunction with corporate) Review and approve QA policies and QC records for medical efficacy JOB REQUIREMENTS: A minimum educational level of an M.D. or D.O. degree is required, additional PHD preferred. A minimum of ten years of experience in clinical medicine is required. A minimum of five years of experience in the pharmaceutical industry is required. Expert in drug development, clinical design and technical regulatory Must be able to think creatively Solid understanding of regulatory requirements, and submission processes, as well as a demonstrated track record of effective regulatory management. Excellent written and verbal communication skills. Effective interpersonal skills Biologics experience preferred Competencies Required: Demonstrated Leadership capability –specific to ability to create and communicate a compelling sense of core purpose and ability to solicit opportunities and possibilities. Demonstrated Influence and interpersonal capability sufficient to achieve strong relationships and results both internal and external to Cellular Therapeutics. Broad strategic capability demonstrated by capturing opportunities. Demonstrated decision-making and problem solving capability sufficient to apply to both organizational dynamics and business possibilities.