Head of Clinical Outcomes, Medical Devices, BK Medical / 1770/CLOSED

The Company
BK Medical is committed to designing ultrasound systems that help surgeons image, guide, intervene, and navigate inside the human body. Surgeons are BK Medicals customers, and they range from HPB surgeons, neurosurgeons, and robotic-assisted surgeons to urologists, colorectal surgeons, and more.

Their mission at BK Medical is to enable real-time intraoperative guidance during surgical procedures, giving surgeons the information needed to immediately make critical decisions. BK Medical’s products are designed and customized for surgical procedures, to help surgeons save time and get better results.

As a market leader, BK Medical works closely with experts and universities to provide the best solutions to clinical challenges. BK Medical most recently joined the GE Healthcare family and is on a very exciting integration journey.
BK Medical supports employees in developing their skills and expertise and have a professional and informal organization with flexible working conditions and a flat organizational structure. BK Medical’s employees are effective and can execute ideas into strong products – these ingredients make them an exciting and development-oriented workplace. An international company with sales offices all over the world, 700 employees in total and 250 at the European HQ, based in Herlev.

The Organization and Team
The clinical area is a part of the Marketing function belonging to the global organization with offices in Herlev, Denmark and the Global Headquarter in Boston, Massachusetts, USA.

You will be joining a clinical function under development. Their ambitions are high, and they will ensure great team spirit, a scientific but fun environment and focus on cross functional collaboration to make the team a success.
The clinical functionis responsible for generating relevant clinical data and to elevate clinical evidence of safety and performance to ensure sufficient, timely and compliant clinical documentation to support registration and drive commercialization of BK Medical’s product range.

As the function is brand new you will be instrumental in building the clinical study area in collaboration with the head of the function and other relevant stakeholders across the business.

BK Medical offers an exciting job in an international company where you can gain great influence and responsibility.

Head of Clinical Outcomes, Medical Devices
Skilled & dedicated with potential to become a Leader

• A market leader with customized products for surgical procedures
• You will be working strategically with clinical studies for Medical Devices Class II - III globally
• You have great influence and work with a broad diversity of products and projects

The Challenge
Do you also love clinical data, and would you like to lead all clinical study activities for super exciting surgical imaging systems to improve surgical outcomes? You will be joining a brand-new clinical function under development. As Head of Clinical Outcomes you will drive planning and execution of especially premarket Clinical Investigation in accordance with ISO 14155 but also PMCF clinical surveys, to generate the needed evidence.

You will:

Drive the availability of clinical data for BK Medical´s medical devices to support the business and be responsible for delivering timely and appropriate clinical evidence for both new products as well as legacy products
Be responsible for design of all clinical investigations including driving protocol development and discussing their clinical plans with regulatory authorities and investigators
Develop, maintain, and expand collaborations with outside clinical investigators, researchers and thought leaders to facilitate the optimum performance of clinical development programs
Manage the process of screening, qualifying, selecting, and contracting with investigators, sites and vendors required for conduct of clinical investigations and other clinical study activities in collaboration with Clinical Study Specialists and develop timelines and budgets
Obtain necessary clinical study approvals from IRBs/ECs, regulatory bodies, and Competent Authorities as relevant and ensure studies are on track for site initiation, patient recruitment and enrolment, and take corrective actions where necessary to address issues
Develop SOPs and work instructions to assure internal files and clinical study files (patient; site; country) conform to Good Clinical Practice regulations and standards
Identify clinical study training needs and develop training materials for in-house and clinical site use
Help in providing oversight of investigator-sponsored studies

BK Medical offers a challenging position within a dedicated company that is characterized by high quality, result orientation, and speedy realization of the goals. Since BK Medical experiences rapid growth, there will be good opportunities for personal development and an international career. You will report to the head of the clinical function.

Your Talent
You have a degree in Life Sciences or related disciplines. You have 5+ years in a clinical position within MedTech or a MedTech CRO and 5+ years direct experience in clinical investigation management. Demonstrated expert knowledge and comprehensive understanding of applicable GCP, ICH guidelines & FDA and applicable international regulations e.g., ISO 14155. You have knowledge of electronic data capture systems and web-based clinical study management tools.

As a person you thrive on working in an environment with a diversity of people, products, and projects. You integrate well into a team as well as working independently on an assignment.

The successful candidate has high quality standards and is committed to meet deadlines. In addition, you are well organized, pro-active, flexible and can work on multiple tasks. Ability to communicate well verbally and in writing is essential. Willing and able to travel domestically and internationally as required.

In other words, you have a desire to support and enrich BK Medical’s culture and would love to work in a leading company with customized products for surgical procedures.

Application
Best Talent is responsible for the recruitment for this position at BK Medical and review your application on a confidential basis. Forward your application including your CV attention “1770/Head of Clinical Outcomes” by way of
e-mail to job@besttalent.dk You can read more about Best Talent at www.besttalent.dk.