Mannkind today listed a new job opening for a trial manager position (tracking code 85-219); they appear to be beefing up the trial administrative staff in Paramus.
The following Medical Director position was also posted today. A position requiring similar credentials was posted some weeks ago but Yahoo's message recall system is currently FUBAR so I am unable to compare this posting with the earlier one.
Medical Director, Diabetes
Tracking Code 84-219
MannKind Corporation is currently seeking a Medical Director, Diabetes who will be 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 Medical Director will provide medical expertise and oversight in the execution of clinical trials. This position will be based in our Paramus, NJ office and will include necessary business travel.
Specific job duties include, but are not limited to the following:
Provide medical expertise to clinical trials in the drug and device development process
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
Understanding of the drug development process, clinical operations, marketing principles and strategies
Experience with diabetes, endocrinology and/or metabolic drugs in an development capacity
Phase III clinical trials experience
Medical degree (M.D. or D.O.) and current license to practice clinical medicine 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 of 2 years of clinical experience within endocrinology including 3 – 5 years within the pharmaceutical industry required
Minimum 5 years of clinical research experience both outside and within the industry including multi-center trials
Paramus, NJ, US.
This is horrible news. Either this key person is leaving the company and requiring replacement or has never been hired despite trials beginning months ago.
Mannkind is a company is total disarray. If you can't keep the website up and running what are the chances of successfully completing 2 phase 3 trials?
Hopefully this is for something other than the current TI trials. It does not bode well to think they are still staffing in order to manage the two trials currently underway; they started them six months ago.