Chief Medical Officer

Scandinavian Real Heart AB (SRH) is developing a Total Artificial Heart (TAH) called the ‘Realheart TAH’ that replaces the natural heart and is intended to save the lives of patients suffering late stage heart failure. SRH is based in Västerås, Sweden and listed on Nasdaq First North Growth.
SRH is looking for candidates motivated to progress the technology from the development stage to clinical use and commercialization. An opportunity exists for a Chief Medical Officer to join the small and dynamic team to oversee all aspects of project management
The ideal candidate will have demonstrated experience in preclinical and clinical project management in the field of medical devices.
Key Objective
To define and implement the preclinical and clinical evaluation plan for the required testing and clinical trials to reach the market in a time efficient and safe manner. To oversee and coordinate different preclinical and clinical research projects in the company to ensure they meet regulatory requirements and commercial goals. Manage the communication with regulatory authorities regarding preclinical data submission and regulatory submission to gain approval to carry out clinical trials. Develop and implement training program for future clinical users. Ethics applications and grant applications for preclinical and clinical studies. Documentation, presentation, and publication of preclinical and clinical data in scientific journals and at conferences.
Responsibilities
To work with the preclinical and clinical teams and corporate management to develop schedules and plans for preclinical and clinical projects
Defining and implementing preclinical and clinical test plans
Manage the data collection, analysis, and presentation of preclinical data
Regulatory submissions to the FDA and communication with notified body
Ethical applications and grant applications
Develop clinical training programs for clinical partners
Build and educate the team and manage and mentor staff
Monitoring projects to ensure goals are met on a daily basis
Budgeting and resource planning

Skills and Experience
Medical doctor or nurse with clinical experience from ICU patients
10 years’ work experience in the field of preclinical artificial heart research
Experience from regulatory submissions to the FDA
Experience from ethics applications and grant applications
Experienced author of scientific publications in peer-review journals
Speaker at scientific conferences
Five years’ experience in a regulated environment such as medical device development.
Demonstrated ability to work in a small, innovative team.
Risk management experience
Cost control and budgeting skills
Proven ability to steer external partners ensuring that project plans are followed, and deviations are communicated.
Excellent verbal and writing communications skills
Fluent in English is a must, Swedish language skills would be valued
Proven networking skills and a good relationship builder