Episurf Medical AB, founded as a spin-off from Diamorph AB in 2009, is a Swedish medical technology company aimed at helping people with painful joints to live a more active life by providing them with effective and individualized treatments. The patient-specific technology is developed in conjunction with top universities and clinical centres in Europe. Several short- and long-term pre-clinical studies were performed during 2009-2011 in order to verify the performance of the implants and to improve the functionality of the surgical technology. These studies were done in collaboration with Kungliga Tekniska Högskolan (The Royal Institution of Technology), orthopaedic surgeons at the Karolinska University Hospital, Charité University Hospital of Berlin and the Swedish University of Agricultural Sciences.
The Episurf idea focuses on the fact that every patient is unique. Given the extraordinary mechanical stress to which human joints are subject, surgical precision of the utmost degree is essential.  This can only be achieved consistently and safely by adapting a new approach in personalized healthcare. A field that Episurf is pioneering by developing and manufacturing individually customized implants and instruments to each patient’s unique anatomy and injury.
Episurf is based in Stockholm and has currently fifteen employees. The company is listed at NASDAQ OMX Stockholm.
Clinical Operations & Scientific Affairs Manager – Global TILLSATT
Opportunity
The market potential for a method to repair limited cartilage damage that provide better treatment results than existing alternatives such as micro-fracturing is estimated to have a potential of $980 million in the U.S. alone. Orthopaedic surgeons around the world feel that there is a treatment gap for the treatment of early osteoarthritis. 70% of surgeons feel that there is a lacking of procedure that ​​provide pain relief, provides an alternative to osteotomi / UKA / TKA and allows significant reduction of pain medication. A successful concept benefits to the community through ​​an alternative to invasive surgery with subsequent long rehabilitation, less time to be able to return to work and, allow sport / exercise to prevent obesity.
The Episealer® products are patient unique implants that immediately recreate the original articular surface with a perfect adaptation to patient's anatomy. The company has two CE marked products; Episealer® femoral condyle – for the treatment of cartilage lesions in the knee condyle and Episealer® trochlea – for the treatment of cartilage damage in the area behind the knee cap.
This is an opportunity to work in a key role with a broad spectrum of responsibilities in an expanding Medtech company and to contribute to the growth of the company. The work is with international focus and performed not only within clinical operations but also in close cooperation with other departments such as R&D, Regulatory Affairs, Development and the international sales/marketing organisation. This role represents an outstanding opportunity to play an important role in Episurf’s market expansion and to act as a bridge between clinical operations and other departments. The role will contain a broad scope of responsibility and a huge opportunity to influence the clinical operation strategy and execution and manage that it is in line with the market expansion and the Life Cycle Management strategy. The position demands that the new incumbent has influence, gravitas and presence in order to impact the business. You will be a part of a dynamic, skilled, collaborative and ambitious team with an open and pleasant atmosphere. There will be plenty of options for personal development within Episurf.

The position
The company has a lean organisation comprising fifteen employees, which includes clinical operations, technical development, Regulatory Affairs & QA, sales/marketing, finance and production.
The company now needs to appoint a Manager Clinical Operations & Scientific Affairs (CO&SA) with the main responsibility to strategically and operational drive the work concerning the clinical evaluation of all the company's development projects and products, and to actively participate in discussions between the R&D and marketing organisation. In order to contribute to the process you need to have a good knowledge regarding regulatory requirements and international standards (of specific importance are EU and USA). The role is placed at the Episurf headquarters in Stockholm. The CO&SA will take responsibility and take an active part in the development of the Clinical Operation program for the existing and coming CE-labelled products. In order to lead, participate and execute the planning of the clinical development program including risk assessments, impact analysis and budget forecasting you need to have a very good knowledge and understanding in clinical trial methodology and scientific affairs within the medtech sector. Further you have to assure that the development program are in full compliance with FDA and all applicable international regulatory requirements.
Responsibilities include planning and implementation of clinical trials including start-up and outcome meetings, write compilation from the literature, contribute to scientific publications and other publications, conferences, and other media, as appropriate. The work involves a lot of contacts both internally (to actively take part in the strategically discussion) and externally with international consultants, distributors and clinicians (orthopaedic surgeons), which places high demands on the understanding of different cultures as well as a great diplomatic skills.

You must have a medical knowledge and excellent skills in clinical trials and associated methodology, ISO-14155, international regulatory requirements (EU and FDA are of importance) and SOPs. In order to take part in the strategically discussion it is desirably if you have experience of acting as the “bridge” between marketing/sales and clinical operations. You have a strong drive with the ability to take initiative and are good at communicating. As the company is small, you must have a "can do" attitude and not be afraid to roll up your sleeves. While you're independent, you can also enjoy having a coordinating and project management role in a team working toward a common goal.

Qualifications
This pivotal role within Episurf requires a professional individual whose qualities and experience include the following parameters:
Requirement (must have):
BA or MSc in Technical/Natural Sciences, Business Administration or equivalent.
At least 5 years’ international experience in a CRO or medtech industry - with a solid background in design, implementation, completion and reporting of trials - preferably from a small / medium size company engaged in product development
Documented international experience with regulatory requirements and international standards (of specific importance are EU and USA)
Documented experience in writing:
· literature reviews based on scientific data e.g. in connection with CE labelling
· scientific publications in collaboration with clinicians (advantage with orthopaedic surgeons)
· labelling texts, assist the sales/marketing department in writing marketing materials, etc.
Project management / lead multicultural study teams
Selection and contracting of subcontractors / CRO
Gained a solid understanding of the Clinical Operations requirements to facilitate and develop relevant tools and programmes based on market needs and aligned with global strategy.
Desirably (nice to have):
Experience and an understanding of what it means to work in smaller companies with strong development potential
Knowledgeable concerning Europe’s different reimbursement systems
Experienced in collaboration with clinicians within the orthopaedic field concerning study design, follow up and general discussion concerning their scientific/market needs
Language:
Fluent in oral/written Swedish and English

For more information about the position and inquiries please contact Jarl Molin, recruitment consultants at Peak Search.
Telephone: +46 8 545 00 100, Mobile: +46 70 560 20 56
jarl.molin@peaksearch.se
http://www.peaksearch.se