Sensorion, le début d’une belle aventure

CLINICAL RESEARCH PHYSICIAN F/M

PARIS - CDI

Entreprise

Sensorion is a pioneering clinical-stage biotech company, which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders. Its clinical-stage portfolio includes one Phase 2 product: SENS-401 (Arazasetron) for sudden sensorineural hearing loss (SSNHL).

Sensorion has built a unique R&D technology platform to expand its understanding of the pathophysiology and etiology of inner ear related diseases enabling it to select the best targets and modalities for drug candidates.

The Company is also working on the identification of biomarkers to improve diagnosis of these underserved illnesses. Sensorion has launched in the second half of 2019 two preclinical gene therapy programs aiming at correcting hereditary monogenic forms of deafness including Usher Type 1 and deafness caused by a mutation of the gene encoding for Otoferlin.

The Company is uniquely placed through its platforms and pipeline of potential therapeutics to make a lasting positive impact on hundreds of thousands of people with inner ear related disorders; a significant global unmet medical need.

www.sensorion-pharma.com

Poste

Reporting to the Medical Director, the Clinical Research Physician F/M develops and drafts study protocols, presents them to the various internal and external stakeholders and is the medical referent on its projects. The position is based in Paris or in Montpellier.

 

Main Activities

 

  • Responsibility and monitoring of clinical activities:

Participate in regulatory submissions and discussions with health authorities / ethics committee in conjunction with the regulatory department;

Review or drafting of supporting documents for the clinical study (protocol, investigator brochure and inform consent form, case report form and patient diary, etc.);

Review and validation of clinical data during the study and coordination of data analysis;

Control of the progress of clinical studies;

Management of subcontracting activities related to the production of clinical study reports;

Control and validation of clinical study reports and publications of clinical study results;

 

  • Responsible of the quality of clinical documents according to international standards and internal procedures

 

  • Establishment and animation of networks of investigators and opinion leaders;

 

  • Presentation of clinical development projects to health authorities, investigators, opinion leaders and congresses;

 

  • Review and follow-up of adverse events, review of narratives (initial/follow-up), write or review annual safety reports

 

Profil

    • Diploma:
      • State Diploma of Doctor of Medicine or PhD or equivalent

 

    • Prior Experience:
      • At least 5 years of experience in a similar position
      • Significant experience in a health industry: biotech, pharmaceutical industry, health industry provider, etc.
      • Expertise in a rare disease and/or in gene therapy would be a plus

 

    • Tongues:
      • Fluent in French & English

 

    • Crossfunctional skills:
      • Have operational and fluent English
      • Be comfortable and effective in communication, while being diplomatic
      • Work as a team and cross-functionally ((R&D, Regulatory Affairs, Quality, Legal, Marketing and Finance)
      • Have writing skills and a capacity for analysis and synthesis
      • Be rigorous, autonomous and dynamic
      • Have a keen sense of listening and communication
      • Be flexible, adaptable and flexible
      • Have ethics (respect for the patient and the confidentiality of this data)
      • Comply with company policy

 

    • Business skills:
    • Have a methodological approach to clinical studies, analysis, use of study results, statistical processing and bibliographic research
    • Have medical knowledge, clinical trial procedures and good clinical practices
    • Know the guidelines and regulatory references in medical writing (clinical and regulatory documentation)
    • Know how to write clinical study reports and scientific publications according to regulatory standards
    • Analyze, interpret and synthesize data from pre-clinical / clinical studies
    • Proficiency in MS Word, Excel, Powerpoint and Adobe Acrobat Professional

Postuler

Postuler