Clinical Development Scientist - US Tech Solutions, Inc.
Cambridge or Remote, MA 02142
About the Job
Seeking an experienced Clinical Development Scientist to join our team as we continue to advance our clinical development programs in rare cholestatic liver disease. In this position, you will be an integral part of the clinical development team supporting the execution of late-stage clinical studies. The ideal candidate will have outstanding communication skills, attention to detail, and the ability to thrive independently in a highly innovative and fast paced environment.
Job Responsibilities
Review, analyze, and interpret emerging clinical trial data (including biomarkers, clinical pharmacology, and safety data) and lead preparation for key study meetings (e.g. investigator meetings, monitoring committees, advisory boards)
Partner with the medical director on oversight of clinical trial activities, including safety reviews and site interactions
Liaise with the broader clinical development team (clinical operations, data management, statistics/programming, and regulatory teams)
Contribute to authoring key study and regulatory documents (e.g. protocol, ICF, study manuals, briefing books)
Lead internal meetings to review topics and develop mitigation plans
Contribute to the development of presentations, abstracts, and publications emerging from clinical studies
Ensure compliance of all activities with ICH/GCP guidelines, applicable regulatory requirements, and SOPs
Other duties as assigned
Qualifications
Advanced degree in life sciences (PhD, MD, or PharmD)
3+ years of clinical development experience in an industry setting
Experience with the development of key clinical study documents
Experience with the analysis and review of clinical data
Working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies
Track record of working with and managing CROs and external vendors
Strong attention to detail and organizational skills
Exceptional verbal and written communication skills
Ability to build strong relationships and work effectively with cross-functional teams
Job Responsibilities
Review, analyze, and interpret emerging clinical trial data (including biomarkers, clinical pharmacology, and safety data) and lead preparation for key study meetings (e.g. investigator meetings, monitoring committees, advisory boards)
Partner with the medical director on oversight of clinical trial activities, including safety reviews and site interactions
Liaise with the broader clinical development team (clinical operations, data management, statistics/programming, and regulatory teams)
Contribute to authoring key study and regulatory documents (e.g. protocol, ICF, study manuals, briefing books)
Lead internal meetings to review topics and develop mitigation plans
Contribute to the development of presentations, abstracts, and publications emerging from clinical studies
Ensure compliance of all activities with ICH/GCP guidelines, applicable regulatory requirements, and SOPs
Other duties as assigned
Qualifications
Advanced degree in life sciences (PhD, MD, or PharmD)
3+ years of clinical development experience in an industry setting
Experience with the development of key clinical study documents
Experience with the analysis and review of clinical data
Working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies
Track record of working with and managing CROs and external vendors
Strong attention to detail and organizational skills
Exceptional verbal and written communication skills
Ability to build strong relationships and work effectively with cross-functional teams
Source : US Tech Solutions, Inc.