Clinical Scientist & Liaison Manager (Hybrid in NYC)
Our client is seeking a highly skilled and motivated Clinical Scientist and Liaison Manager with extensive clinical science experience to join their dynamic clinical development team.
Company offers a very generous compensation & benefits package.
THIS ROLE INVOLVES:
Protocol development: Objectives, methodology, data collection methods, and analysis plans.
Medical writing: Writing, reviewing, and updating the clinical trial protocol, informed consent documents, and case report forms (CRFs).
Regulatory Submissions: Investigational New Drug (IND) applications, New Drug (NDA) applications, Clinical Trial (CTA) applications
Data Management: Data Analysis reports, eCRF review, Quality Control
Communication: Preparing presentations, manuscripts, clinical study reports (CSR) and other scientific communications based on study results, KOL interaction
KEY RESPONSIBILITIES:
Scientific & Clinical Research Project & Content:
Design, implement, and manage clinical research documents and studies to support product development and regulatory approval.
Analyze and interpret and communicate scientific & clinical data, ensuring accuracy and scientific integrity.
Ensure all clinical trial documentation complies with regulatory requirements, company policies, and ethical standards.
Prepare and present clinical study reports, summaries, and publications for internal and external dissemination.
Monitor and report study progress to relevant authorities and stakeholders.
Stakeholder Liaison:
Serve as the main point of contact between the company, clinical sites, and external partners, including regulatory bodies and key opinion leaders (KOLs).
Facilitate clear and consistent communication to address any inquiries, concerns, or updates related to clinical projects.
Build and maintain strong relationships with clinical investigators, healthcare professionals, and other stakeholders.
R&D Strategy Support:
Contribute to the development of clinical strategies and trial designs that align with company objectives.
Provide scientific input and expertise in the preparation of regulatory submissions and presentations.
Support in licensing projects, clinical and indication strategy assessment.
EXPERIENCE:
A minimum of 5 years' experience in clinical research or pharmaceutical industry role with proven experience in clinical science, project management and liaison responsibilities.
EDUCATION: MD or PhD or PharmD
OTHER:
Knowledge of Good Clinical Practices (GCP) and regulatory requirements.
Travel as needed to clinical sites, conferences, and partner meetings.