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Job Details

Requisition Number 17-0005
Post Date 1/27/2017
Title Medical Director
City Danbury or Valencia
Description

Senior Medical Director, Clinical Development is responsible for developing, planning and implementing clinical research direction and vision that are in support of corporate goals and timelines. The incumbent will establish and implement scientific methods for design and implementation of clinical protocols, data collection and final reports, including authoring of scientific documents and publications. Additionally, the Senior Medical Director will provide medical expertise and oversight in the execution of clinical trials. This position may be based in either our Danbury, CT or Valencia, CA office and will include necessary business travel.

  • Provide medical expertise to clinical trials in the drug and device development process.
  • Draft and/or review and edit protocols to ensure accuracy, consistency with standard of care, logistical ease and internal consistency with MannKind.
  • Develop, plan and implement clinical research direction and vision that are in support of corporate goals and timelines.
  • Manage and approve the establishment of scientific methods for design and implementation of clinical protocols, data collection and final reports.
  • Provide clinical expertise to development project teams and assume leadership role, as appropriate, in providing clinical guidance to development, marketing and operations groups.
  • Provide scientific and medical expertise in support of business development activities and maintain close working relationships with R & D clinical groups, operations and marketing staff.
  • Provide operational support to team in clinical trial planning, protocol development, investigator selection, training of internal and external personnel, medical monitoring for trial safety and quality control.
  • Provide consistent and appropriate medical monitoring to ensure patient safety and adequate reporting and coding of adverse events in clinical trials.
  • Write and edit clinical reports for regulatory submission and updates consistent with medical accuracy.
  • Support clinical staff for review of product complaints, MDR reporting criteria, health risk assessments and product performance criteria.
  • Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.
  • Responsible for observing all Company, Health, Safety and Environmental guidelines. Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.
Requirements
  • Knowledge of ability to apply the science and methods of basic statistics to clinical study design considerations deriving descriptive data outcome conclusions.
  • Experience in writing scientific reports essential.
  • Medical degree (M.D. or D.O.) with specialization in Endocrinology, board certification preferred, board eligibility accepted OR demonstrates extensive experience/expertise in metabolic drug development or R & D experience within related medical fields.
  • Minimum 10 years of clinical research experience both outside and within the industry including multi-center trials.
  • Understanding of the drug development process, clinical operations, marketing principles and strategies.
  • Prefer experience with diabetes, endocrinology and/or metabolic drugs in an development capacity.
  • Phase III clinical trials experience.
  • Understanding of the drug development process, clinical operations, marketing principles and strategies.
  • Strong meeting facilitation, verbal presentation and decision making skills.
  • Previous management / supervisory experience.
  • Proven record of successfully delivering projects on time with the highest quality.
Apply On-line
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