||Head of Clinical Development
• Lead clinician responsible for the strategy, planning, implementation and medical monitoring of the company’s clinical research programs.
• Lead clinical strategist for product development programs
• Primary contact with corporate partners on clinical aspects of Alexza’s commercial product(s)
• Member of Alexza management team
• Oversee development of the strategy for the company’s clinical research programs
• Oversee the operations and management of the company’s clinical trials, including data collection and generation of final study reports, ensuring compliance with Good Clinical Practice and all applicable regulatory standards
• Oversee the analysis and interpretation of all clinical study data in support of reports for publication and regulatory submissions
• Work with regulatory affairs group to prepare regulatory applications required to support the company’s clinical programs and product approval
• Serve as lead clinical strategist and medical reviewer for the development of the company’s product candidates
• Serve as lead medical reviewer and clinical strategist for all business development activities, including assessments of therapeutic candidates for development by the company.
• Serve as clinical lead for all interactions with regulatory agencies
• Serve as a medical monitor for clinical trials and marketed products, and as clinical author of safety reports to regulatory agencies
• Serve as lead clinical liaison to clinicians, thought leaders, and other companies
• Serve as a member of the management team, helping set company business strategy, methods of operation and policies
• Serve as lead clinical / scientific reviewer of all company scientific publications and product labeling
• Contribute to company’s intellectual property portfolio
• Hire staff necessary to meet company’s clinical research objectives
• Serve as clinical liaison to Ferrer counterparts. Serve as clinical lead at joint Alexza-Ferrer meetings
• MD degree and significant experience in the design and management of clinical trials
• Excellent written and verbal communications skills.
• Ability to develop, organize and implement clinical trials operations.
• Significant assessment and risk management experience.
• General working knowledge of computer and company standardized software.
• Ability to work with company management, regulatory agencies and community at large.
• Ability to establish clinical and scientific department policies and procedures.
• Strong manager and leader, capable of working with complex problems and solutions
Education and experience:
• MD degree; 10+ years of industry experience in clinical development, with increasing experience in role and responsibility (EU/global experience is desirable)
• Experience with drug delivery technologies, plus/minus experience with pulmonary delivery a plus
• Experience with clinical pharmacology and drug safety is a plus