Our client is looking for a Clinical Manager/Director in the Aesthetic Applications field. The position reports to the Vice-President.
The candidate shall lead and manage all bio-clinical activities for new and existing devices, from concept and feasibility stages, via investigative processes for R&D, regulatory, marketing and PMS evaluations and toward establishing treatment protocols and conclusion remarks.
Activities and responsibilities include, but are not limited to:
- Overseeing all bio-clinical missions – from determination of (clinical) market needs, scientific conceptual analysis, feasibility check, risk assessment, pre-clinical and clinical trial activities – from study design and development of related documentation, via study approval of ethic committee, study execution and its monitoring, toward study termination, data analysis, queries resolving, establishment of downstream treatment protocols, writing scientific papers and regulatory and other reporting, and all per related policies and regulations and under Clinical Research Quality System.
- The position includes interview and recommendation of investigators and clinical sites, review of contracts, estimation of related budget and on-going cost analysis, and responsibility for allocation of human, equipment and financial resources per project’s priority.
- The position works closely with the different relevant company entities, including R&D, marketing and regulatory and supports and provides the scientific merit, while keeping subject’s safety and clinical data safety, toward high quality commercial products.
REQUIRED EDUCATION, EXPERIENCE AND SKILLS:
- PhD/MSc in Biology / Medical-sciences / Biomedical engineering
- At least 5 years’ experience in similar executive position in a Medical Device Company, preferably in the Dermatology / Plastic surgery / Aesthetic arena
- Hands-on experience in design and execution of ex-vivo and in-vivo Pre-Clinical and Clinical trials
- Experience in Energy Tissue Interaction, preferably at Physiology / Histology level
- Experience in working with Ethic Committees and MOH / FDA, as well as with physicians
- Track record of due-time Execution of the above
- CRA course / GCP practice
- Regulatory knowledge is an advantage
- Team worker that can work as an Independent Investigator
- Multitasking with Creative Thinking
- Excellent Writing and Presentation skills
- Excellent Interpersonal and Communication skills
- Enthusiastic, marketing oriented
- Results and Performance driven
TYPICAL WORKING CONDITIONS AND AVAILABILITY:
- Full time job, intensive work
- Office based work plus occasional evening or weekend work
- Worldwide travel will be required, per needs
- Bi monthly salary plus performance based commission
***PLEASE ATTACH YOUR RESUME AS A PDF DOCUMENT WITH THIS APPLICATION. Thank you!