Clinical Research Medical Director, Pulmonology – California
January 23rd, 2018 by adminTanner & Associates is recruiting a Clinical Research Medical Director in Pulmonology for a large biotech company based in California. Please send CV to careers@biotechserach.com
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.
Please send a CV and contact information to Jake Tanner at careers@www.biotechsearch.com . US candidates only please.
Thanks,
Jake Tanner
Tanner & Associates
760.598.3363