Clinical Research Medical Director, Pulmonology—Southern California

Tanner and Associates is recruiting a Clinical Research Medical Director of Pulmonology for a worldwide Biotechnology company located in Southern California.

Responsibilities:

• Develops and executes medical strategies for Asthma molecules.
• Provides medical support during development of Asthma molecules, especially during Phase II.
• Leads planning and execution of scientific deliverables outlined in the company’s Regional North American Medical Plan.
• Supports cross-functional and global collaborations to integrate broad medical, scientific and commercial input into the development program.
• Provides medical/scientific support for regional brand strategic objectives.
• Develops and manages key external and regional relationships according to the Key Opinion Leader Plan.
• Makes scientific presentations at advisory boards, key scientific meetings and external committee meetings as delegated.
• Participates in conducting safety assessments.
• Participates in interactions with regulatory agencies.
• Authors clinical study reports, publications and regulatory submissions
• Designs, prepares and initiates study protocols and other required documentation in compliance with project plans, federal regulations, GCP, and good medical practices.
• Analyze and interpret clinical study data and prepare reports for FDA and publications. Will serve as the primary medical monitor on assigned projects.

Qualifications:

• MD with 2 or more years of clinical research and/or basic science experience research.

Preferences:

• Board Certified or Board Eligible in Pulmonology or Allergy/Immunology.
• Five or more years of clinical research experience combined with clinical teaching and patient care.
• Familiar with investigators or institutions in Pulmonology.
• Ability in leading, managing and motivating a staff.
• Clinical research experience in the biopharmaceutical industry (Biotech, Pharmaceutical or CRO).
• Medical/Scientific Knowledge:
  In depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale.
• Familiar with basic concepts of clinical research and clinical trial design, including biostatistics.
• Knowledge of GCP, FDA and EMEA/CHMP regulations and guidelines and applicable international regulatory requirements.
• Demonstrated ability to serve as a medical expert in a complex matrix environment.