MedImmune6 - Durham North Carolina 27603

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Job Position: Senior Director, R&D
Job Location: Gaithersburg, MD US
Job Status: Full-Time

Position Details
Title: Senior Director, R&D Location: MD, Gaithersburg - Corporate Headquarters Req: 02112 Position Summary: This position will provide technical, operational, and strategic leadership for the Biological Analysis group within the Analytical Biochemistry department. Technical areas include: bioassay, immunoassay, PCR, and biosensor method development, in-process, and release testing. Major Duties and Responsibilities (including supervising others): - Establish strategy, direction and objectives for a rapidly growing group of 40 plus that are consistent with overall function, R&D, and MedImmune goals and objectives - Develop strategic plans for clinical and commercial products to support pre-clinical development, clinical product development, product life-cycle management and associated regulatory submissions. - Provide technical advice, where needed, to assure the highest quality of data is developed and presented. - Serve as spokesperson for Development in verbal and written communications with regulatory agencies, R&D product development teams for all therapeutic areas, and other internal and external groups of interest. - Oversee the creation and review of presentations for outside scientific meetings and conferences to assure they meet corporate standards. - Proactively, participate in diligence activities with Business Development and author summary of findings. - Oversee the creation and review of documents such as: method development reports, SOPs, validation protocols/reports, CMC regulatory filings (IND, IMPD, BLA, etc.), and scientific journal publications. - Develop new cutting-edge technologies for improving efficiency of in-process testing and product characterization. - Actively maintain and evolve the department's strategic direction to meet organizational needs. - Maintain effective communications with Process Development groups as well as Regulatory Affairs, Clinical Development, Quality Control, Quality Assurance and Research. - Assure all laboratory documentation and other regulatory compliance systems are maintained according to corporate standards. - Ensure effective day to day operations of the organization including talent development, performance management, budgeting, etc.

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