Clinical Scientist
Location
United States
Posted
5 days ago
Salary
Not specified
No structured requirement data.
Job Description
- Advanced degree in Life Sciences (PhD, PharmD, or MSc preferred; MD not required)
- Minimum of 2+ years of experience in clinical development, clinical research, or medical affairs with increasing responsibility
- Prior experience supporting Phase II–III clinical trials (Phase IV experience a plus)
- Demonstrated ability to independently draft and review scientific and clinical documents
- Strong understanding of GCP, clinical trial methodology, and regulatory expectations
- Excellent scientific writing, data interpretation, and presentation skills
- Highly organized, detail‑oriented, and able to manage multiple deliverables in a fast‑paced environment
- Contribute scientific input to the design and execution of Phase II–IV clinical trials, including study rationale, objectives, endpoints, and protocol content
- Serve as the scientific owner or primary contributor for assigned studies or components of a clinical
- program
- Interpret clinical data and scientific literature to inform protocol development, program strategy, and internal decision‑making
- Identify scientific risks, data gaps, or inconsistencies and propose evidence‑based solutions
- Draft, review, and maintain clinical trial protocols, study synopses, and related clinical documents
- Support preparation of clinical sections of regulatory submissions, briefing packages, and responses
- Ensure scientific accuracy, clarity, and consistency across protocols, regulatory documents, and presentations
- Develop scientific narratives, data summaries, and slide content for governance, leadership, and board‑level discussions
- Act as a scientific liaison with Clinical Operations, Biostatistics, Regulatory Affairs, Medical Affairs, and other cross‑functional partners
- Facilitate cross‑functional discussions to resolve scientific questions and align on clinical strategy and timelines
- Translate complex scientific concepts into clear, concise messaging for non‑scientific stakeholders
- Support scientific content for interactions with regulatory agencies, advisory boards, and Key Opinion Leaders (KOLs)
- Prepare scientific briefing materials and background documentation for external meetings
- Incorporate feedback from external experts into clinical documentation and program strategy
Medical, Dental, Vision Insurance
Life/AD&D
Short- and Long-Term Disability
401(K) with large company match
Health Saving Account (HSA) and Flexible Spending Account (FSA) with company match
Wellness Program
Employee Assistance Program (EAP)
Generous Paid Time Off (PTO)
Disclaimer: The included statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
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