•Manage the Pharmaceutical R&D group in executing on development projects to ensure that company goals are achieved. Contribute to and/or lead the CMC aspects of product development programs as a core team member/leader or through other Pharmaceutical R&D core team members/leaders.
•Ensure that sound technical data sufficient for regulatory filings is collected and appropriately reviewed. Oversee primary responsibility for writing CMC sections of regulatory filings. Ensure that Pharmaceutical R&D activities are conducted in compliance with applicable GMP and QSR requirements.
•Develop and budget resource forecasts. Identify new initiatives and infrastructure as needed to meet broader group objectives. Ensure that laboratory space and equipment are adequate, qualified as needed, and safe. Ensure staff is adequately trained.
•Work together with President & COO on key aspects and strategy of Alexza Intellectual Property
•Work with other functional groups (i.e. Product Development, Engineering, Manufacturing, QC, QA, Regulatory) on the technical aspects of pipeline projects. Work closely with manufacturing and project teams to ensure timely delivery of supplies to support clinical development efforts.
•Work closely within the R&D organization to identify, evaluate and recommend new concepts for product candidates .
•Self-motivated and able to work independently
•Organized and able to lead a functional group of high-level individual contributors, and also cross-functional teams, utilizing solid interpersonal and team skills
•Able to build and maintain good relationships with peers across the company
•Excellent communication skills, both verbal and written
•Strong background in more than one of the following: chemistry, aerosols, drug development, formulation development
•Working understanding of cGMP and QSR regulations and guidances applicable to the development of combination drug products and inhalation products
Education and Experience:
M.S. or Ph.D. in Chemistry, Chemical Engineering or equivalent
At least 12+ years of relevant experience in pharmaceutical research & development or equivalent
•Cross-functional Team Leadership
Level of education
Tagged as: Executive Director or Vice President Pharmaceutical R&D
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