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Arbetsbeskrivning
Bactiguard is a global medtech company that is driven by values and a strong sense of purpose in making the world a healthier place by preventing infections. We provide safe and easy-to-use infection prevention technology and solutions across five therapeutic areas. We operate through license partnerships with large global medtech companies and through a portfolio of coated medical devices.
We are looking for a medical expert with responsibility for all clinical activities and the licensing business from a clinical and technical perspective. You will play a key role in strategizing and executing clinical development plans, ensuring adherence to ethical guidelines and regulatory compliance, and ultimately helping to bring innovative therapies/technologies to patients.
Your tasks and responsibilities, among others:
Identifying and establishing relationships with KOLs and principal investigators
Medical training internally as well as for distributors and healthcare professionals
Management and maintenance of Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) as well as Post market surveillance
Research activities to substantiate Mechanism of Action of the Bactiguard technology and clinical/in-vitro claims
Evaluation of the Bactiguard coating on new materials and devices with respect to microbial adhesion, toxicity, and biocompatibility (i.e. efficacy and safety)
Identifying clinical needs for infection control and applications/devices that would benefit from Bactiguard’s infection preventive coating
Ensure that clinical trials are conducted ethically and adhere to the highest standards of patient safety.
Packaging and presenting the medical and clinical benefits of adding Bactiguard’s coating to devices/applications of potential license partners
Managing and coordinating the joint research & development activities between Bactiguard and license partners
You will work in close collaboration with our CEO by giving scientific support during strategic planning, strategic decisions, and investor meetings
Competence requirements:
Medical degree
Clinical experience as practicing physician
Scientific research experience
Experience from the pharmaceutical, medtech or biotech industry
Experience in preclinical and early/late clinical development
Experience in clinical trials, either as investigator or as industry medical representative
Experience with regulatory activities in US and EU
Significant global exposure working in various geographies
Excellent oral and written communication skills with successful presentation capabilities.