von Heute

Senior Clinical Scientist

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Senior Clinical Scientist

Debiopharm Group? (Debiopharm) is a Swiss - based biopharmaceutical group of four companies active in drug development, GMP manufacturing of proprietary drugs, diagnostics, and investments. Debiopharm International SA searches, evaluates and in - licenses promising drug candidates for development. Towards the end of the development process, the products are licensed out to pharmaceutical companies for world - wide marketing and sales. For our Clinical Medicine Service, Clinical Research & Development Departm ent based at our Headquater in Lausanne, we are looking for a SENIOR CLINICAL SCIENTIST The senior clinical scientist develops promising Debiopharm molecules into medicine that fulfil patient's needs and provides them with the best value. He/she works in close collaboration with the Medical Director and cross - functional clinical study teams and provide clinical science support for assigned programs. Your responsi bilities · Drive development of clinical development plans and protocols for clinical studies; · Prepare and/or provide input to clinical study related and other regulatory documents (e.g. CSRs, IBs, PIS/ICFs, SAPs, Data Management Plans, IN D, briefing books); · Monitor, review and interpret safety and efficacy data of ongoing studies; · Represent clinical R&D in cross - functional project core teams; · Serve as clinical expert in communications with Regulatory Authorities worldwide; · Act as (clinical science expert) liaison to clinical study teams, CRO's, study sites and others; · Participate in cross - functional clinical study team meetings; · Establish relationships with investigators, KOLs, partners and appropriate consultants; · Provide clinical scientific input to business development (e.g. due diligence) and marketing activities; · Perform literature research as needed; · Develop and deliver presentations to internal and external stakeholders. Your profile · Master 's Degree required, advanced Clinical/Science Degree is preferred (e.g. PhD, MD, MSN, MPH, etc.). · Experience in Oncology and/or Infectious Diseases is a plus. · 5+ years of relevant experience in clinical development within the pharmaceutical industry. · Data listing review experience. Broad experience in the principles and techniques of data analysis, interpretation and clinical relevance. · Well - versed in medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation), FDA, EME A and other relevant guidelines and regulations · Has knowledge of the multidisciplinary functions involved in drug development process (e.g.: clinical operations, biostatistics, regulatory, business, etc.) and can proactively integrate multiple perspectives into the clinical development process for best end - results. · Driven and has proven abilities to perform responsibilities independently and with limited guidance. · Excellent project management skills: can prioritize multiple tasks and goals to ensure the tim ely, on - target and within - budget. Focused on results, flexible and open - minded, able to adjust to changing circumstances. · Strong interpersonal, verbal/written communication, negotiation and influencing skills. · Proven track record of effective decision - maki ng: makes good business decisions and exercises sound judgment. · Proven teamwork skills: has a proven track record of working highly effectively, efficiently and collaboratively with multidisciplinary teams. Demonstrate curiosity and challenge status - quo. · Ability to travel (

CP 5911 /Chemin Messidor 5-7 1002 Lausanne