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:
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Responsible for trial design and endpoint development in collaboration with CD; collaborates with medical writing to develop trial results communication forinvestigators
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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
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Sets up/supports SAC, DMC, adjudication committee; provides scientific input to SM for data management activities (e.g.EDC, DRP, CRF’s_
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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
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May act as mentor to other Clinical Scientists

Requirements:

Education:
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Degree in Life Sciences orsignificant experiencein clinical development (>14 years)
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BS/BA with 7+yrsclinical research experience
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MS/PhD with 5+ years clinical research experience
Experience:
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Minimum 2yearspharmaceutical and clinical drug development experience in a Clinical Scientist role as a leadrequired.
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Proven ability to effectively manage multiple complexstudies
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Medical monitoring experiencerequired
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TA-specific experience in Immunology
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Excellent Excel and PP skillsrequired
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Excellent written and oral communication skills
Target Pay Range for US: $135-150K
Physical Demands/Work Environment:
Work Environment:
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Work is performed in an office environment with exposure to electrical office equipment.
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Frequent travel to clients/ site locations with occasional travel both domestic and international.
Physical Requirements:
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Ability to sit for extended periods and operate a vehicle safely.
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Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
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Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
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Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
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Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
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Regular and consistent attendance.
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Varied hours may be required.
Learn more about our EEO & Accommodations request here.