Highlights

In this role, the selected candidate will lead/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). 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 the CSR  .

Description

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.*** 

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 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 the CSR

May act as mentor to other Clinical 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 .

Proven ability to effectively manage multiple complex studies

Medical monitoring experience

TA-specific experience in Immunology

Excellent Excel and PP skills

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.