FSP Sr. Clinical Scientist - Immunology

Senior Clinical Scientist, FSP – Immunology – Remote US or Canada ***Position leads Phase 1-3 Clinical Trials and oversees medical monitoring. This is not a laboratory/research scientist role.*** In this role, the selected candidatewilllead/support studies;be accountable for the clinical/scientific execution of theprotocol; bethe clinical point of contact for scientific issues/questions for internal and external stakeholders (e.g., IRB, sites); and act as scientific lead on Clinical Trial Team (CTT). Responsibilities include: - Responsible for trial design and endpoint development in collaboration with CD; collaborates with medical writing to develop trial results communication forinvestigators - Leads the Medical Monitoring (MM) team in performing MM activities, including development of the Medical Monitoring Plan (MMP) and review of SAE reports, monitoring dataissuesand central labreports - Sets up/supports SAC, DMC, adjudication committee; provides scientific input to SM for data management activities (e.g.EDC, DRP, CRF’s_ - Protocols/amendments – collaborates with medical writing,participatesin governance committee review; authors protocol clarification letters; reconciles and reviews all protocol deviation classifications and assess and prepares protocol deviation list for theCSR - May act as mentor to other Clinical Scientists Requirements: Education: - Degree in Life Sciences orsignificant experiencein clinical development (>14 years) - BS/BA with 7+yrsclinical research experience - MS/PhD with 5+ years clinical research experience Experience: - Minimum 2yearspharmaceutical and clinical drug development experience in a Clinical Scientist role as a leadrequired. - Proven ability to effectively manage multiple complexstudies - Medical monitoring experiencerequired - TA-specific experience in Immunology - Excellent Excel and PP skillsrequired - Excellent written and oral communication skills Target Pay Range for US: $135-150K Physical Demands/Work Environment: Work Environment: - Work is performed in an office environment with exposure to electrical office equipment. - Frequent travel to clients/ site locations with occasional travel both domestic and international. Physical Requirements: - Ability to sit for extended periods and operate a vehicle safely. - Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. - Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. - Ability to access and use a variety of computer software developed both in-house and off-the-shelf. - Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. - Regular and consistent attendance. - Varied hours may be required. Learn more about our EEO & Accommodations request here. Originally posted on Himalayas