Alexza Pharmaceuticals is a specialty pharmaceutical company located in Palo
Alto, 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
Clinical Research Scientist. The Clinical Scientist will work closely
with our multi-disciplinary team of clinicians, scientists and
engineers in advancing products through early- to late-stage clinical
development. The Clinical Scientist will participate in all aspects of
clinical development, including the writing of clinical sections of
regulatory submissions, clinical protocol development, generation of
statistical analysis plans, interpretation of clinical research, and
participation on cross-functional project teams. The Clinical Scientist
may interact with investigational sites, clinical consultants, CROs and
other vendors.

The Clinical Research Scientist will
participate in the direction, planning, execution, and interpretation
of clinical research, data collection activities, and clinical
operations. Establish and approve scientific methods for design and
implementation of clinical protocols and final reports. Work with
others to develop statistical plans and perform data analysis of
completed clinical trials. Support new and ongoing clinical research
and clinical trials and ensure efficient and timely processing of
Confidentiality Agreements and Clinical Agreements. Monitors adherence
to protocols and study progress.. May interact with Investigational
sites, clinical consultants, CRO’s and other vendors. Review and
summarize medical literature for purposes of Regulatory submissions and
product selection and development.
Responsibilities:
• Serve as clinical development lead for one or more drug development projects
and serve as the clinical development member of the associated
cross-functional project team(s).
• Participate in generating the clinical strategy for one or more development programs.
• Develop statistical plans and perform preliminary and exploratory data analyses of completed clinical trials.
• Write clinical trial protocols, protocol amendments, and clinical study project timelines.
• Write clinical study reports.
• Write clinical sections of regulatory submissions.
• Write manuscripts for journal publication.
• Work with clinical operations group in overseeing activities of
clinical sites to ensure strict compliance with study protocols and
overall clinical objectives.
• Interpret and summarize clinical
literature for integration into clinical documents, regulatory
documents, presentations, etc.
• Present scientific data internally, and at scientific meetings, as required.

Skills required:
• Experience in the development and writing of clinical study protocols,
investigator brochures, and clinical sections of regulatory
submissions.
• Experience as a core project team member for pharmaceutical or biotech products.
• Through understanding of FDA, ICH and GCP requirements for clinical development programs.
• Excellent communication skills.

Education and Experience:
• PhD, PharmD, or MD.
• Minimum of 2 years of pharmaceutical industry clinical trial experience.

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.