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.
- 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.
- MD with 2 or more years of clinical research and/or basic science experience research.
- 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.
Please send a CV and contact information to Jake Tanner at email@example.com . US candidates only please.
Tanner & Associates