Scientific & Clinical Affairs manager
We are seeking a Scientific & Clinical Affairs manager with a strong clinical and scientific background and network in orthopedics. You will use your clinical and scientific knowledge to deliver a significant societal contribution in providing a joint saving treatment for people with a painful end-stage osteoarthritis of the knee joint.
You will be responsible for the shaping and realisation of our clinical research program to obtain reimbursement, regulatory approval and market acceptance of the KneeReviver. You play a key role within the ArthroSave team and work closely together with the Medical Officer. You will act in line with the company strategy supporting implementation of the KneeReviver in international patient healthcare within the businessplan timelines.
For this role, it is key to know all ins and outs to successfully execute the clinical pathway to gain clinical evidence, reimbursement and to further develop and understand the treatment. It is important being up-to-date about relevant clinical and scientific developments and publications in the field of joint preservation and joint distraction. The scientific and clinical activities are always in line with the company strategy bringing the KneeReviver successful to the market.
- Take responsibility for the Company Clinical Evidence strategy
- Define and manage clinical study programs in EU and US
- Build and manage relationships with clinicians, possible clinical trial sites, CRO(’s), regulatory authorities and consultants
- Collaboration with a strategic consulting company for regulatory approval in the US
- Ensure clinical trials are executed on budget and within strict timelines
- Be responsible for regulatory submission/maintenance dossiers at Notified Bodies and FDA
- Take responsibility for the Company Research projects
- Be responsible for optimization of the clinical procedure/treatment and the required research
- Involve the orthopedic clinical and scientific network to collaborate, KOL engagement
- Keep track of medical and scientific developments and publications
- Manage the writing of scientific publications in support of our clinical and regulatory objectives
- Support marketing and sales with scientific input
- Be responsible for funding research projects
What do we offer?
You will be working in a team of passionate professionals, committed to our purpose and to each other. You will be given a lot of responsibility and freedom to operate, with plenty of support from the management team whenever you need it. You will work at our location in Culemborg. We offer an attractive salary.
We are ArthroSave
ArthroSave is an ambitious medtech start-up founded in 2016 and is based in Culemborg, the Netherlands. Our mission is to let patients return to a more active way of life by improvement of osteoarthritic joints. As a result of a 6 weeks knee joint distraction treatment the osteoarthritic pain reduces and mobility improves. To achieve this we developed the KneeReviver which is CE certified and has been validated in a clinical trial. The KneeReviver has been commercially used in fifteen hospitals in five European countries.
To become a main player in this multi-billion market we want to convince international healthcare institutions for reimbursement. In the upcoming period our ambition is to gain evidence for reimbursement in target countries and to get regulatory approval in the US. Further development of the clinical procedure, clinical pilots and reimbursement trials will be part of the market access strategy.
- Minimal MD or MSc. graduate in a relevant field of study (Medicine, Biomedical, Technical Medicin etc.)
- 5+ year experience in managing clinical research programs in both EU and US
- 10+ year of professional working experience in medical devices
- Experience in orthopedic clinical research is recommended
- Experience in orthopedic clinical setting is a plus
- Recent experience in regulatory affairs is a plus
- You are an excellent writer, communicator and collaborator
- You are a self-starter, eager to find your way despite budget limitation
- You are a team player and are able to motivate and lead others
- You are creative and outside the box thinking, you find solutions in order to achieve the expectations
You can send your application letter not later than 30 June 2023 to firstname.lastname@example.org
Acquisition based on this vacancy is not appreciated.