Clinical Science Expert

LausanneFixe2018-06-12Non exigé / Non qualifié
Spring Life Sciences is looking for his client a

Clinical Science Expert

The Role:

• The clinical scientist develops promising molecules into medicine that fulfil patient's needs and provides them with the best value.
• You works in close collaboration with the Medical Director and cross-functional clinical study teams and provide clinical science support for assigned programs.

Responsibilities:

• 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, IND, 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.

Profile:

• Master's Degree required, advanced Clinical/Science Degree is preferred (e.g. PhD, MSN, MPH, etc.).
• Experience in Oncology and/or Infectious Diseases is a plus.
• 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, EMEA 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 timely, 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-making: makes good business decisions and exercises sound judgment.

Votre contact

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La référence de cette offre est JN -062018-49843 - HAID

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