Director, Clinical Development

Alexza Pharmaceuticals is a specialty pharmaceutical company located in Mountain View, California. We are developing breakthrough therapies for the treatment of acute and intermittent medical conditions. Alexza was founded by Dr. Alejandro Zaffaroni who is one of the most successful entrepreneurs in the biomedical industry with a long list of successful start-ups to his credit, including ALZA, Affymax and Affymetrix Corporations.

We have an exciting opportunity for a Director, Clinical Development. This person will work closely with our multi-disciplinary team of scientists and engineers who are dedicated to the development of novel drug delivery technologies with the potential to revolutionize the treatment of several common diseases.

This position includes general oversight of our clinical development activities, and specific clinical development responsibility for one or more of our product candidates.

Responsibilities:
• Serves as internal clinical champion for one or more development programs.
• Serves as lead clinical author for various clinical and regulatory documents/submissions.
• Serves as lead clinical representative for assigned regulatory agency interactions.
• Serves as lead clinical representative for assigned partnering activities.
• Serves as clinical leader for the assessment of new product candidates.
• Serves as a source of medical expertise supporting all product development activities as a senior member of the medical affairs group.
• Provides hands-on leadership and guidance to multidisciplinary project teams in the development and implementation of all clinical trial programs.
• Responsible for establishing communication with prominent clinical investigators.
• Assures that all protocols, clinical trial data bases, and SOPs are fully compliant with FDA, ICH or any other governing regulatory agency.
• Assures that all communications with regulatory agencies are accurate, timely, and compliant with all applicable regulations.
• Oversees selection of appropriate clinical investigators or contract organizations.
• Communicate the progress toward product development milestones to Company management.
• Attends appropriate scientific meetings to maintain awareness of research activities.

Skills required:
• Ability to successfully develop and complete Phase 1-3 clinical trials and file NDAs.
• Thorough knowledge of the drug development process, FDA (and other ex-US regulatory) requirements and regulatory strategies and the experience of taking a drug successfully through the FDA approval process.
• Excellent written and verbal communication skills.
• Ability to effectively lead multi-disciplinary teams working within a fast-paced environment on multiple programs.
• Strong analytical, evaluation, and interpretation skills.
• Ability to multi-task and set priorities to accomplish multiple clinical development goals with an effectively staffed team and vendors including CRO’s
• A strong team builder and team player.
• Constant awareness of the impact of the clinical and regulatory strategy on the overall Company objectives.

Education and experience:
• MD in Psychiatry, Neurology, Anesthesiology or related field and 4+ years experience in the biotechnology/pharmaceutical industry.
• Ideal history will include at least one NDA and a proven track record in successful clinical trial design, in both pharmaceutical products and medical devices.
• Working knowledge of clinical development and regulatory affairs, as well as pre-clinical work necessary to support an IND.
• Experience with GMP-regulated pharmaceuticals, medical instrumentation or other regulated industry environment.
• Experience in ensuring Contract Research Organizations meet all study requirements, timelines, and remain within budget.
• Knowledge of CDER, CDRH, ICH and other regulatory requirements.

We offer competitive compensation and benefits including stock options, an exciting and collaborative work environment and excellent opportunity for career growth. Alexza Pharmaceuticals is an Equal Opportunity Employer. Direct Applicants only - NO AGENCIES, PLEASE.