Remote Director | Clinical Research Scientist

Job Overview

Join our esteemed organization as a Director | Clinical Research Scientist, where you will occupy a crucial position in shaping the design, execution, analysis, and reporting of clinical trials. By collaborating closely with the VP of Clinical Development, you will harness your scientific acumen and clinical research background to support the comprehensive drug development process, from pre-clinical discovery to successful product registration and commercialization.

Key Responsibilities

• Review, interpret, and effectively communicate scientific data concerning the efficacy and safety of developing compounds.
• Collaborate diligently with the VP of Clinical Development, clinical trial managers, and clinical operations managers throughout the lifecycle of clinical studies.
• Engage in continuous learning by attending relevant congresses and reviewing pertinent literature to enhance your expertise in specific therapeutic areas.
• Contribute to the development of program strategies such as clinical development plans, product lifecycle strategies, target product profiles, and draft labels.
• Analyze the competitive landscape to identify and assess business development opportunities.
• Provide scientific and clinical study support from study initiation through to Clinical Study Reports (CSRs) and subsequent publications.
• Participate in the scientific education of internal and external stakeholders regarding relevant pre-clinical and clinical data.
• Build relationships with opinion leaders to enhance the visibility of the pipeline and encourage research collaborations.
• Contribute to the scientific content of study protocols, investigator brochures, CSRs, informed consent forms, and regulatory documentation.
• Assist in the creation of electronic databases, interactive response technology (IRT), and related training documents, ensuring the completeness of data throughout the study.
• Collaborate cross-functionally to develop a scientific platform that underpins regulatory, commercial, and medical education strategies for late-stage assets.
• Ensure compliance with Good Clinical Practices, pharmacovigilance standards, and all relevant quality assurance protocols in research. Participate in the authorship of regulatory responses and meetings.
  
  

Required Skills

• Strong collaborative abilities within a cross-functional team environment.
• Comprehensive knowledge of clinical trial methodologies and regulatory compliance.
• Capacity to provide informed contributions and oversight to clinical research with appropriate guidance.
• Exceptional analytical capabilities for evaluating scientific data.
• Proficiency in designing study protocols and scientific documentation.
  
  

Qualifications

• An advanced degree in a scientific discipline (PharmD, PhD, or RN) is preferred, although an advanced MS degree with relevant experience will also be considered.
• A minimum of 2 years of clinical trial experience within the pharmaceutical industry as a Clinical Research Scientist is required.
• A keen desire to collaborate and thrive in a team-oriented environment.
  
  

Career Growth Opportunities

This role presents substantial opportunities for professional development by facilitating engagement with opinion leaders, involvement in scientific education, and contributions to diverse scientific and regulatory documents, thereby elevating your expertise in clinical research and drug development.

Company Culture And Values

You will flourish in a dynamic, interactive, fast-paced, and entrepreneurial atmosphere, which supports a balanced approach to professional and personal life. This position offers flexibility for remote work with occasional domestic travel (up to 10%).

Employment Type: Full-Time