Clinical Science Leader Job in Plan-Les-Ouates (Ch)
NovImmune SA is a drug discovery and development company located in Geneva (CH) that focuses on developing therapeutic monoclonal antibodies for inflammatory diseases and immune-related disorders. To date, NovImmune has generated seven antibodies, four of which are currently in clinical development, reflecting a balance between preclinical and clinical development activities for validated as well as novel targets.
In October 2009, NovImmune won the competitive European Biotechnica Award, for innovation and strong product focus. In July 2010, NovImmune successfully entered into an exclusive licensing agreement with Genentech Inc. for a proprietary anti-IL-17 fully human monoclonal antibody, and access to back-up antibodies.
NovImmune is seeking a Clinical Development professional to join its Clinical Science Department. Reporting to the Head of Clinical Science, the individual will lead the development strategy for one of our innovative monoclonal antibody and express his/her entrepreneurial talents to have a key impact on the success of the company.
Major responsibilities:
- Primary responsible of clinical trial protocol development, including sections related to scientific background and specific study drug information.
- Development of clinical sections in different strategic document’s such as protocol, investigator brochure, clinical development plan and coordinate the success completion of documents.
- Primary point of contact for medical monitor inquiries from sites.
- Perform clinical review and interpretation of data listings.
- In conjunction with Biostatistician and Head of Clinical Science review appropriate analysis and reporting documents.
- In collaboration with Regulatory Affairs, prepare clinical section of packages to be submitted to Regulatory Agencies, and participate in meetings, as required. Assist in generation and review of clinical documents required for regulatory submissions.
- Collaborate to the preparation of CRF design, according to specific protocol requirements as well as data quality plan.
- Create and give presentation for internal and external meetings (i.e. Investigators' meetings, monitors’ meeting, site initiation visits and CRA training).
- In collaboration with the Drug Safety Department, participate in Safety Advisory Boards and tracking/analysis of safety/tolerability data.
- Draft abstracts/posters and coordinate review/submission to scientific meetings as well as any other publicly distributed materials referred to ongoing clinical trials.
- Participate in Business Development and Licensing activities.
- Be a core member of the Project team and the clinical representative in the interface with other functions and departments.
Candidate should have:
- MD or PhD in Biology or any other relevant scientific discipline,
- At least 5 years of professional experience in clinical science in the pharmaceutical industry,
- Sound knowledge of scientific principles, preferably with background in immunology, or inflammatory disorders
- Excellent communication, organization and tracking skills,
- Excellent knowledge of Good Clinical Practice,
- Willing to be part of interdisciplinary teams with spirit of initiative and proactivity,
- Excellent written and spoken English; Fluency in French is a plus.
If your profile matches the above description, please send us your CV and motivation letter under the reference CLIN/CSL to the following email address: hr@novimmune.com