At INBRAIN Neuroelectronics we're looking for a Clinical Head to help us DECODE BRAIN SIGNALS INTO MEDICAL SOLUTIONS!
ABOUT THE ROLE
INBRAIN is seeking a Clinical Head willing to take a leadership role in the strategic planning and execution for INBRAIN clinical development projects.
1) Establishing and evaluating development project strategy and clinical development plans in line with company objectives and current regulatory and quality requirements.;
2) Coordinate design and approval of Clinical Investigation plans (CIP), defining endpoints/objectives, overseeing the clinical integrity of studies.;
3) Create and maintain the Clinical Evaluation Report (CER).;
4) Conduct ongoing medical review of clinical trial data, analyzing potential issues and risks that could affect the project, particularly those relating to the quality and integrity of the data, clinical efficacy of device performance and safety of the device.;
5) Overseeing selection and interaction with Contract Research Organizations (CRO).;
6) Responsible for setting up & execution of Clinical procedures.;
7) Responsible for clinical risk management and usability evaluations & validation.;
8) Coordinate research for internal/external publications, on clinical data, usability, Quality of Life data for market access and reimbursement.;
9) Analyze and communicate results on clinical trials, providing input into clinical development strategies, clinical study report writing.;
10) Ensure effective and efficient clinical documentation standards in writing processes are implemented and maintained.;
11) Contribute to regulatory discussions with regulatory bodies both in Europe and US.;
12) Developing and maintaining relationships with Key Opinion Leaders (KOL), the company Advisory Board Members and other external experts.
1) MD with at least 7 years of medical science/clinical development experience in neuromodulation, gained within MedTech industry (start-up experience would be an advantage).;
2) Proven experience in clinical development of Class III active implantable medical devices (EU and FDA).;
3) Proven experience in leading clinical studies for pre-market approved devices.;
4) Proven leadership skills in managing teams of culturally diverse backgrounds.;
5) Excellent written and verbal communication skills.;
6) Excellent planning and prioritization skills.;
7) Fluent in English (company language). Other languages (Spanish, Dutch, German, French) would be an advantage.
WHAT INBRAIN OFFERS
1) An opportunity to revolutionize neurostimulation and work within one of the most dynamic, multi-disciplinary start-ups in Europe.;
2) Growth potential. We expect rapid advancement of team members who have an outsized impact.;
3) A fun but balanced organization with flexible work & vacation policy.;
4) A potential stock option plan.