Job Title: Pharma/Biotech Expert Evaluator
Job Type: Contract, Part-time
Location: Remote
Job Summary:
Join our customer's team as a Pharma/Biotech Expert Evaluator, where you will leverage your advanced scientific expertise to assess cutting-edge pharmaceutical and biotechnology research. This is a unique opportunity to influence the quality and integrity of research in a dynamic, remote environment, collaborating with leading professionals in the field.
Key Responsibilities:
• Critically evaluate scientific materials, research summaries, experimental designs, and clinical trial data for rigor, accuracy, and clarity.
• Assess the depth of scientific reasoning, domain expertise, and problem-solving across drug discovery, preclinical, and clinical development stages.
• Review, critique, and synthesize scientific literature, mechanisms of action, and study methodologies with attention to regulatory relevance.
• Apply industry-standard frameworks (FDA, EMA, ICH) to the evaluation of clinical and nonclinical documentation.
• Identify methodological strengths and weaknesses, providing actionable, structured feedback based on established scientific and regulatory standards.
• Collaborate with the customer's team to uphold high standards of research evaluation and domain-specific knowledge.
• Communicate findings effectively through clear, precise written and verbal reports.
Required Skills and Qualifications:
• PhD in pharmacology, biochemistry, molecular biology, drug discovery, or a closely related discipline; OR MS/BS with commensurate experience.
• Minimum 5 years of experience in pharmaceutical or biotech R&D settings.
• At least 3 years of hands-on experience in drug discovery, preclinical/clinical development, or biotech research.
• Expertise in at least two areas: drug discovery/target validation, clinical trials, PK/PD, medicinal chemistry, biologics/cell & gene therapies, regulatory affairs, or drug safety/toxicology.
• Comprehensive understanding of FDA and EMA regulatory frameworks and documentation.
• Exceptional critical evaluation and data interpretation skills, with the ability to discern methodological soundness.
• Outstanding written and verbal communication abilities, essential for delivering high-quality feedback and collaborating remotely with the team.
Preferred Qualifications:
• Peer-reviewed publication record in pharmaceutical or biotechnology research.
• Experience authoring or reviewing regulatory documentation (e.g., IND, IMPD, CTD).
• Background in mentoring, teaching, or evaluating scientific talent.
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