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Requisition Number 18-0004
Post Date 4/11/2018
Title Executive Dir Pharmaceutical Development
City Mountain View
State CA
Description Responsibilities:
The Head/Executive Director, Pharmaceutical Development will lead a group of scientists in the development of Alexza’s drug-device combination products. These activities will include: working with peers to select future drug candidates/indications, assessing feasibility of potential drug candidates; defining, developing & optimizing product performance attributes; product development through all phases of clinical development, with emphasis on early clinical stages; providing technical leadership & coordinating CMC regulatory efforts; coordinating development activities with Device Engineering group;

The Head/Executive Director, Pharmaceutical Development will:
• Manage the Pharmaceutical Development group in executing on drug development programs and projects. Provide scientific and technical expertise input into selection of new drug candidates and development programs. Lead the CMC aspects of product development programs. Work closely with the Device Engineering group to ensure that the device used for a given development program is appropriate for its intended purpose.
• Part of the team responsible for the strategy, planning and implementation of the company’s research and development including clinical research programs.
• 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 Development 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 peers on key aspects and strategy of Alexza Intellectual Property
• Coordinate with other functional groups to ensure timely delivery of clinical trial materials for clinical studies
• Work closely within the R&D organization with Business Development to identify, evaluate and recommend new concepts for product candidates in Alexza’s pipeline.
• Lead effort to prepare data packages to support post-approval CMC changes. Serve as Subject Matter Expert during interactions with regulatory authorities.

Skills Required:
• Proven leadership ability
• Able to multi-task in dynamic environment
• Sound decision-making and judgement
• Product development experience from preclinical to clinical stage
• Experience in early clinical development
• Experience with FDA and EMA and understanding of regulatory requirements
• 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, aerosol science, drug development
• Working understanding of cGMP and QSR regulations and guidances applicable to the development of drug-device combination products and inhalation products

Requirements Education and Experience:
• M.S. or Ph.D. in chemistry, biochemistry, pharmaceutical science, chemical engineering or equivalent
• Experience developing drug-device combination products is a must
• Experience with oral inhalation products is highly desirable
• Experience with commercial products is a plus
• At least 10-12 years of experience in pharmaceutical research & development or equivalent; with at least 3 years in a senior leadership role
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