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 candidate   will   lea d/support studies;   be accountable for the clinical/scientific execution of the   protocol; be   the 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 data   issues   and 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 writ ing ,   participates   in governance committee review ; authors protocol clarification letters; reconciles and reviews all protocol deviation classifications and assess and prepares protocol deviation list for the   CSR

• May act as mentor to other C linical Scientists

Requirements

Education

• 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

Experience

• Minimum 2   years   pharmaceutical 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

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 .