Clinical Scientist

2 months ago

new york city, United States Masis Professional Group Full time

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.


MUST HAVES:


  • Strong Scientific Background: A solid scientific foundation, such as a PhD in molecular biology or oncology, is important for understanding and communicating complex clinical matters.
  • Protocol Writing: Someone capable of taking ownership of clinical study protocols and drafting sections independently.
  • KOL Experience: Relationships with Key Opinion Leaders (KOLs) are key for advancing clinical trials and medical strategies.
  • FDA Requirements and Compliance: Experience in implementing FDA requirements, like diversity plans in study protocols, is important.
  • Hands-on Study Execution: Candidates should be confident in taking on key responsibilities such as CRO selection, site meetings, and study protocol development.
  • Analytical Skills: The role requires strong analytical skills, particularly in assessing clinical data and solving operational challenges.


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
  • Safety reports: Adverse event review, Pharmacovigilance Reports
  • 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: PhD in molecular biology or oncology is preferred.

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