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 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). 

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 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.

• Occasiona