Leica Biosystems is a global leader in workflow solutions and laboratory automation for anatomical pathology bringing clinicians and researchers high workflow efficiency and confidence in cancer diagnostics. We provide a comprehensive product range with easy-to-use and consistently reliable solutions, from sample preparation and staining to imaging and reporting.
At Leica Biosystems, we value our customers as partners, and therefore strive to deliver excellence in everything we do.
We are currently recruiting for a Medical Director. This is a key role which will be prominent within our Advanced Staining Global leadership team with a remit of providing pre and post-market medical affairs advice and support to functions throughout the business. They key areas of focus will be within Research and Development, Regulatory Affairs and our Pharmaceutical Partnership business unit.
Working out of our offices in Danvers, Massachusetts, the successful candidate must be an MD with board certification and training in anatomic pathology with at least 5 years post qualification experience ideally gathered in the Medical Device or Pharmaceutical Industry or within a Clinical Reference Laboratory.
The Medical Director will have responsibility for
providing medical insight to the development of design specifications, medical expertise to regulatory submissions; participation in meetings with regulators (e.g. FDA) and the reviewing of marketing and promotional materials.
providing medical expertise to device risk analyses, health hazard evaluations (HHE), adverse event review, and risk/benefit reports on behalf of new product development programs and on-going (post-market) surveillance activities.
supporting the growth of LBS’s Pharmaceutical Partnerships business through cultivation of peer-to-peer relationships within pharmaceutical companies.
playing an integral role in building LBS’s brand as a thought leader; actively participate in planning and provision of training for external medical/scientific speakers and members of product sales teams
The ideal candidate will have
A deep understanding of/experience with laboratory medicine and anatomic pathology.
An M.D. degree with American Board of Medical Specialities certification in an appropriate speciality (anatomic and clinical pathology, preferred).
Molecular tissue pathology experience.
Experience in risk management/safety assessments in the medical devices industry is desirable.
Successful experience in advocating and advancing in vitro diagnostic products
History of planning and participating in global medical advisory boards and managing relationships with external experts.
Experience of interacting with regulatory agencies on pre and post-market issues.
Leica Biosystems is a global leader in workflow solutions and automation. As the only company to own the workflow from biopsy to diagnosis, we are uniquely positioned to break down the barriers between each of these steps. Our mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our corporate culture. Our easy-to-use and consistently reliable offerings help improve workf...low efficiency and diagnostic confidence. The company is represented in over 100 countries. It has manufacturing facilities in 9 countries, sales and service organizations in 19 countries, and an international network of dealers.
Visit LeicaBiosystems.com for more information.