What are the responsibilities and job description for the Senior Clinical Scientist - Pharma position at Intellectt Inc?
Job Title: Senior Clinical Scientist (Pharma)
Location: Raleigh, NC
Employment Type: 6 Months contract
Job Overview
We are seeking a highly skilled Senior Clinical Scientist to support global clinical development programs within an R&D environment. This role involves providing scientific and strategic leadership across clinical studies, including study design, execution, data analysis, and regulatory support. The ideal candidate will have strong experience in clinical research across devices, drugs, or biologics, with the ability to collaborate cross-functionally and drive high-quality clinical outcomes.
Key Responsibilities
Clinical Development & Strategy
- Provide scientific and strategic input across all phases of clinical development (devices, drugs, biologics, and combination products)
- Support clinical studies from early development through post-marketing stages
- Collaborate closely with cross-functional teams under the guidance of the Clinical Director
Data Analysis & Interpretation
- Collect, integrate, and analyze data from clinical trials, literature, and research studies
- Interpret clinical data (tables, figures, listings) and generate meaningful insights
- Develop scientific narratives and key messaging based on clinical and preclinical data
Study Execution & Oversight
- Identify and mitigate study-related risks; develop contingency plans
- Ensure timely communication of study progress and issues to stakeholders
- Support planning and execution of investigator meetings, advisory boards, and regulatory interactions
Documentation & Regulatory Support
- Prepare, review, and approve clinical and regulatory documents
- Contribute to regulatory submissions and documents, including:
- Clinical Evaluation Plans (CEP)
- Clinical Evaluation Reports (CER)
- Post-Market Clinical Follow-Up Plans/Reports (PMCFP/PMCFR)
- Instructions for Use (IFU)
- Ensure compliance with Good Clinical Practice (GCP), regulatory guidelines, and internal SOPs
- Support Clinical Outcome Assessment (COA) selection and validation
Communication & Publications
- Prepare and present study results to internal and external stakeholders
- Contribute to manuscripts, abstracts, and publications in line with Good Publication Practices
- Manage medical writing projects and oversee external vendors for quality and compliance
- Support clinical trial data disclosure in public registries
Required Qualifications
- Master’s degree (MSc) in Life Sciences or related field
- Experience in clinical research within pharmaceutical, biotech, or medical device industry
- Strong understanding of clinical development processes and regulatory requirements
- Experience with data analysis, interpretation, and clinical documentation
Preferred Qualifications
- PhD, DrPH, or MD
- Experience with aesthetic products, medical devices, or combination products
- Prior involvement in global clinical trials and regulatory submissions
Key Skills
- Clinical Research & Development
- Data Analysis & Interpretation
- Regulatory Documentation & Compliance
- Project Management & Leadership
- Cross-Functional Collaboration
- Problem Solving & Decision Making
- Scientific Communication