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(H/F) Clinical Director
Il y a 5 mois
Our Clinical Director will manage a skilled clinical team. He/she will be responsible for the following duties (list not exhaustive):
**Clinical strategy**
- Definition and execution of the clinical strategy and roadmap:
- Leading the design and execution of clinical studies promoted by Wandercraft and/or our partners in France and internationally, including the design of protocols and endpoints with partner physicians,
- Selecting leading physicians to provide medical support in target countries and managing scientific committees,
- Proposing the optimal roadmap for extending indications in Europe and the USA,
- Defining the optimal balance of clinical work to ensure proof of medical benefits,
- Managing CROs (contract research organizations) when necessary,
- Development, animation, and maintenance of a professional network, including leading MDs in our field, regulatory and economic authorities,
- Post-market work and collection of real-life data,
- Definition and management of the clinical budget,
- Development of the clinical team by reinforcing internal medical competence.
**Market Access**
- Propose and implement the strategic approach to international market access and pricing strategies in coordination with Business, Marketing, Medical, Regulatory, R&D and Business Development,
- Create or supervise medico-economic material on the interest of our exoskeletons from all our data (field data, clinical study data, bibliographic data),
- Develop and propose healthcare models for the financial coverage of rehab within the existing economic context and the reimbursement system of the various markets,
- Coordinate and write the Global Added Value Dossier,
- Select and coordinate with local partners/providers for market access (economic modelling, dossier/argument writing, dossier submission).
**Scientific and thought leadership**
- Medical representation to health authorities, opinion leaders, the medical profession, media,
- Participation in scientific conferences, congresses, user club events, presentation of clinical cases,
- Discussion, solicitation and KOLs support for participation in congresses, studies...,
- Internal and external communication on upcoming or ongoing studies or results of completed studies.
**Clinical Evaluation**
- Supervision of the maintenance of procedures and certificates,
- Supervision of the update of RECs and POCs, literature reviews,
- Supervision of the semi-annual update of the PMCF.
**Supervision of our walk center, Walk In paris**
- Supervision of the recruitment of staff to support our patients,
- Supervision and medical advice on the development of new patient pathways.
**Support to other teams**
- Maintaining the medical and clinical level in the team. Training of teams in contact with patients and customers,
- Validation of documents for users: Instructions for use, training materials,
- Control and validation of commercial messages delivered, in compliance with ethics and regulations,
- Contributing to the development of the network of regulatory KOLs to define the guidelines around our medical device,
- Participation in team projects,
- Clinical feedback to help R&D developments,
- Creation of clinical / medical content for sales / marketing.
**Required profile**
- You should have a medical or equivalent scientific background or have graduated from a top school with proven skills in clinical development strategy and an international outlook, along with at least one previous experience in the industry,
- You must be highly adaptable, capable of working with regulatory and executive profiles on clinical trials, as well as interacting with doctors, physiotherapists, and healthcare professionals, and eager to promote Wandercraft on an international scale,
- You should have international experience and be a native English speaker (or have excellent proficiency) with fluency in French,
- You should have extensive experience in managing a clinical team, preferably in the medical device industry,
- You must possess excellent oral and written communication skills,
- You should enjoy working with an agile, highly collaborative, fast-moving team that is developing groundbreaking technology to profoundly change the lives of patients.Other required experience:
- MD with a knowledge in disability and/or neurological conditions,
- Experience in market access strategy,
- Expertise in clinical investigation and clinical evaluation.
**Required Skills**:
- Degree: Medical doctor or equivalent scientific training / graduate school having worked in the health industries
- Required experience: first experience in the industry or equivalent
**Expected skills**:
- Clinical Strategy : Trainer
- Clinical Investigation : Expert
- Clinical Evaluation : Expert
- Management : Expert
- English : Expert
- Market Access : Expert
Type d'emploi : CDI
Statut : Cadre
Avantages:
- Participation au transport
- Titre-restaurant
Exigences linguistiques flexibles:
- Français non requis