Sr. Clinical Scientist

Summary

Clinical Scientist/Sr. Clinical Scientist contributes to the trial development strategy assisting with data review and analysis, study design and clinical study execution. Will contribute to clinical filing activities that are part of new drug applications, which can include activities such as preparing/editing regulatory documents and participating in responses to questions from Regulatory Agencies.

Responsibilities

• Assist with the strategy and creation of the clinical development plans for one or more programs.
• Contributed to key strategic documents including clinical development plans, protocol concepts and full protocols for product(s).
• Contribute to the development of clinical sections of regulatory documents such as Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions.
• Review and summarize relevant literature on clinical development programs.
• Support investigators meetings and protocol training meetings.
• The Clinical Scientist is responsible for performing ongoing clinical data review during study execution to ensure integrity of accruing study data and appropriate safety follow-up.
• Analyze and interpret study data from an individual study and translate study level clinical data across the program of studies.
• Ensure that all studies are conducted with the highest level of ethical and safety standards in compliance with GCP and all regulatory policies.
• Coordinate the real time availability of quality clinical trial data, including safety, efficacy, pharmacokinetic and biomarker data, to provide consolidated information for dose escalation meetings and data reviews with investigators.
• Provide support to prepare presentations for advisory boards, steering committee meetings, consultant meetings and investigator meetings.
• Proactively seeking out and recommending process improvements.
• Provide scientific input to the preclinical team for translational studies of interest including biomarker development strategies.
• Maintain current knowledge of the external environment to ensure scientific innovations are considered and/or incorporated into clinical trial development strategy.
• Support authoring/reviewing abstracts, presentations, and manuscripts for external publications.
  
  

Requirements

• Master’s Degree or PharmD/PhD with at least 2-3 years clinical trial/drug development experience. Diabetes experience highly preferred.
• 2-3 years technical, operational and managerial experience in planning, executing, reporting and publishing clinical diabetes studies in a pharmaceutical company and/or contract research organization.
• Proficient with software tools (Microsoft Office Suite), Adobe, SharePoint, Share Drive, and other custom web-based software used data analysis and data visualization (i.e. Spotfire, Tableau etc.)
• Experience authoring new study protocols, CRFs, ICFs, Reports, and other applicable study materials for clinical trial use.
• Experience writing Clinical Study Reports (CSR) with a good understanding of clinical trial operations, clinical trial logistics, and Good Clinical Practices.
• Experience operating effectively within a biotech start-up with complex studies; ability to prioritize tasks and manage multiple priorities and meet deadlines.
• Collaborative, team-oriented mindset with strong verbal and written communication skills.
• Self-motivated, detail-oriented leader with exceptional organizational, leadership and interpersonal skills.