Clinical Research Medical Director, Pulmonology—Southern California

Clinical Research Medical Director, Pulmonology—Southern California

January 9th, 2018 by

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.

Please send a CV and contact information to Jake Tanner at careers@biotechsearch.com .  US candidates only please.

Thanks,

Jake Tanner

Tanner & Associates

Careers@biotechsearch.com

760.598.3363

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