Senior Clinical Scientist

Senior Clinical Scientist

The Specialized Recruiting Group in Durham/RTP is recruiting for a growing pharmaceutical company in Raleigh, NC seeking a Senior Clinical Scientist for a 6-month contract role with the potential for extension and/or conversion to regular, full-time employment.

Contract/Contract-to-hire

Work: On-site role in north Raleigh

Hours: Monday-Friday, 8 AM - 4 PM

Pay: Up to $90/hr (equivalent to $185k )

Travel: Up to 5%

Drive Clinical Strategy for Innovative Products

An opportunity is available for an experienced Senior Clinical Scientist to play a key role in advancing global clinical development programs across medical devices, pharmaceuticals, and biologics.

This position is ideal for a scientifically driven professional who enjoys working cross-functionally to shape clinical strategy, contribute to study design, and translate complex data into meaningful insights that support regulatory approvals and product innovation.

What You’ll Be Doing

Shape Clinical Development Strategy

• Provide scientific and strategic input across all phases of clinical development
• Contribute to trial design, study execution, and data interpretation
• Support early-phase development through analysis of preclinical and exploratory data

Lead Cross-Functional Collaboration

• Partner with internal teams and external experts to drive clinical initiatives
• Integrate data from multiple sources (clinical studies, literature, research) into clear, actionable insights
• Support key meetings including investigator meetings, advisory boards, and regulatory interactions

Own Clinical Documentation

• Author and review critical clinical documents including:
• Clinical study protocols and amendments
• Investigator Brochures
• Clinical study reports
• Ensure all documentation meets regulatory standards (FDA, EMA, ICH, GCP)

Support Study Execution & Analysis

• Contribute to study setup, execution, and results interpretation
• Provide input on clinical outcome assessments (COAs) and validation activities
• Identify risks, troubleshoot issues, and proactively implement solutions

Contribute to Regulatory & Submission Activities

• Provide scientific input into regulatory documents such as:
• Clinical Evaluation Plans (CEP) and Reports (CER)
• Post-Market Clinical Follow-Up (PMCF) documentation
• Support clinical data disclosure and regulatory submissions

Publish & Present Clinical Data

• Prepare and present clinical trial results to internal and external stakeholders
• Contribute to manuscripts, abstracts, and scientific publications
• Apply Good Publication Practices to ensure high-quality outputs

Manage External Vendors

• Oversee outsourced medical writing activities
• Ensure quality, consistency, and adherence to timelines and standards

What We’re Looking For

Required Qualifications

• Master’s degree (MSc) in Life Sciences or related field
• Strong experience in clinical development and clinical trials
• Knowledge of global regulatory requirements (FDA, EMA, ICH, GCP, ISO 14155)
• Proven ability to manage multiple projects and competing priorities
• Excellent scientific writing and communication skills

Preferred Qualifications

• PhD, MD, or DrPH
• Experience across medical devices, pharmaceuticals, or biologics
• Prior involvement in regulatory submissions and approvals

Key Strengths for Success

• Strong scientific thinking and data interpretation skills
• Ability to influence cross-functional teams and stakeholders
• High attention to detail with a strategic mindset
• Adaptability in a fast-paced, evolving environment
• Effective collaboration and leadership capabilities

Why This Role Stands Out

• Direct impact on clinical strategy and product development
• Exposure to global clinical programs and regulatory pathways
• Opportunity to work with cross-functional and international teams
• Potential pathway to a long-term or permanent position

Please apply through LinkedIn today for immediate consideration or reach out with questions.