FSP Sr. Clinical Scientist - Immunology

*** 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 for investigators
• 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 lab reports
• 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,participates in 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

• Degree in Life Sciences or significant experience in clinical development (>14 years)
• BS/BA with 7+yrs clinical research experience
• MS/PhD with 5+ years clinical research experience

• Minimum 2yearspharmaceutical and clinical drug development experience in a Clinical Scientist role as a lead required.
• Proven ability to effectively manage multiple complex studies
• Medical monitoring experience required
• TA-specific experience in Immunology
• Excellent Excel and PP skills required
• Excellent written and oral communication skills

Target Pay Range for US: $135-150K

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.