Clinician (FSP)

Technical/ Behavioral Competencies

• Demonstrated potential or ability to design, initiate and conduct clinical studies in industry, academic, or research clinic setting.
• Proven scientific writing skills, with strong interpersonal, written/ verbal communications skills, including ability to evaluate, interpret and present complex data.
• Ability to review and understand the emerging safety and efficacy profile of the drug candidate; part of this skill is putting the profile in perspective with comparator agents.
• Able to present complex, technical ideas and concepts, both verbally and in writing, in such a way that they are understood by colleagues and stakeholders at all levels and/ or from other disciplines.
• Collaborative problem solving (handles conflict constructively).
• Creativity and/ or ability to put innovative approaches into practice in clinical development.
• Able to embody Client leaders behaviors and the OWN-IT culture.
• Able to anticipate issues related to operational feasibility, recruitment challenges, able to discuss investigator performance issues, coach and/ or mentor clinical investigative site staff to achieve operational and recruitment goals and quality standards.
• Able to place innovative approaches into action that focus on trial execution and site performance.

Qualifications (Training, Education& Prior Experience)

Education

• Required: BA/ BS or equivalent qualification.
• Preferred: M.D., Ph.D., D.V.M., M.S., and/ or PharmD. or equivalent qualifications. Postgraduate training/ certification/ fellowship in a medical discipline or in drug development. Demonstrated scientific productivity (e.g. doctoral thesis, publications, research reports, etc.).

Experience

• Preferred: Thorough understanding of local/ international regulations applicable to clinical trials (pre and post approval). Practical experience in clinical trial strategies, methods and process. Track record of design, oversight and interpretation of clinical studies. Previous leadership/ management experience or training.
• Required: Knowledge and experience in Good Clinical Practices. Experience in conduct and execution of clinical trials, including operational feasibility, recruitment, investigator performance, investigative site relations.