Clinical Scientist

Description:

Description: Our client is currently seeking a Clinical Scientist for a permanent/direct hire position that can sit remotely, but will require occasional onsite visits to the NYC area.

Description
 

• 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)
• Collaborate with the medical monitor on oversight of clinical trial activities, including safety reviews and site interactions.
• Communicate with the broader clinical development team (clinical operations, data management, and regulatory teams)
• Contribute to the writing of 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 creation of presentations, abstracts, and publications emerging from clinical and translational studies.
• Work with clinical and research teams to implement the clinical biomarker strategy for early phase clinical studies.
• Ensure all activities comply with ICH/GCP guidelines, applicable regulatory requirements, and SOPs
• Perform other duties as assigned.
   

Required Education/Qualifications/Skills:
 

• A degree in Life Sciences (MD, PhD, Pharm D, MS or similar scientific field preferred).
• At least 5+ years of experience in clinical science, clinical research, or equivalent is expected.
• Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations.
• Basic understanding of disease area, compound, current clinical landscape.
• Ability to write regulatory documents and lead clinical scientist tasks.
• Knowledge and skills to support program-specific data review and trend identification.
• Advanced medical writing skills and medical terminology.
• Basic knowledge of the establishment and operation of data monitoring committees, medical review teams, and adjudication committees.