Clinical Research Medical Director, Pulmonology—Southern California

TANNER & ASSOC INC • Remote (CA, United States) • $200k - $250k / year • 2m ago

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.
Analyzes and interprets clinical study data and prepares 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.

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).
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.

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