Clinical Research Medical Director, Pulmonology – California

Tanner & Associates is recruiting a Clinical Research Medical Director in Pulmonology for a large biotech company based in California. Please send CV to

Key Responsibilities:

• Develops and executes medical strategies and provides scientific and medical input into the development, execution and communication of global scientific/medical evidence plan for Asthma molecules in Development.
• Provides medical support in the development of a leading asthma molecule in phase II.
• Leads the 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.
• Serves as the primary medical monitor on assigned projects.

Qualifications:

• MD with 5 or more years of clinical research and/or basic science experience research, required.
• MD, 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.
• Clinical research experience in the biopharmaceutical industry (Biotech, Pharmaceutical or CRO).
• Demonstrated ability to serve as a medical expert in a complex matrix environment.

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.