Clinical Research Medical Director, Pulmonology - California

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 View email address on click.appcast.io 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. #J-18808-Ljbffr