Clinical Scientist & Liaison Manager (Hybrid in NYC)
Our client is seeking a highly skilled and motivated Clinical Scientist and Liaison Manager with Clinical Research & Development experience to join their dynamic Clinical Development team! Company offers a very generous compensation & benefits package.
THIS ROLE INVOLVES:
Scientific & Clinical Research Project & Content work:
- Scientific & Clinical Trial Documents: content provision for phase 3 documents (clinical & ethics & regulatory)
- Clinical Scientist for Trial: review and structure ongoing scientific and clinical output of phase 3 study.
- Scientific and Clinical communication: present scientific & clinical information to external parties, coordinate the interaction (ad boards, 1:1, investigator meetings)
- The ideal candidate will possess strong scientific expertise, excellent interpersonal skills, and a commitment to advancing innovative pharmaceutical drug development projects.
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 roles with proven experience in clinical science, project management and liaison responsibilities.
EDUCATION: MD or PhD or PharmD
SKILLS:
- Strong analytical and problem-solving skills with the ability to interpret complex clinical data.
- Excellent written and verbal communication skills with the ability to effectively convey scientific concepts to diverse audiences.
- Strong organizational skills and attention to detail and ability to manage multiple projects simultaneously.
OTHER:
- Knowledge of Good Clinical Practices (GCP) and regulatory requirements.
- Travel as needed to clinical sites, conferences, and partner meetings.