Principal Associate, Clinical Pharmacology Scientific Support & Reporting Writing

Role Summary

Principal Associate, Clinical Pharmacology Scientific Support & Reporting Writing. This role builds the data and information needed to prepare internal documents and scientific reports related to clinical trials, and ensures multiple reports advance in parallel through effective multitasking.

Responsibilities

• Prepare scientific reports/presentations related to clinical trials using available software and templates and; review/contribute to clinical protocols, by utilizing expertise, to assist in interpretation of data.
• Assists in constructing phase 1 clinical study planning documents, and writes Phase 1 protocols.
• Review clinical protocols and key decisions impacting project timelines with management.
• Comply with procedures set forth in relevant IQS documents and Study protocols and other directives issued by the management regarding clinical studies.
• Apply experience to analyze clinical study data, including statistical data using available software to assist with ongoing blinded/un-blinded PK, safety and efficacy reviews and ensure the scientific integrity of all processes.
• Responsible for receiving and completing tasks and assignments from function, Therapeutic Area MD or Scientific Staff within timeline with minimal supervision and; maximizing individual, function/therapeutic area and team productivity.
• Lead the study development by applying most current electronic document conventions/processes most consistently/accurately to ensure scientific integrity of all processes.
• Participate on teams for process improvement initiatives and review key decisions impacting project timelines with management.
• Perform literature/competitive intelligence searches to recognize/resolve scientific and technical problems by applying the most current electronic document conventions and processes consistently and accurately.
• Provide/present key clinical study information to function/therapeutic area and management.
• May lead teams within function/therapeutic area and supervise exempt and/or non-exempt direct reports and mentor function/therapeutic area personnel.

Qualifications

• Bachelors/Master’s degree, in Science related to Field with 9+ years’ experience in the pharmaceutical industry or Pharm-D/PhD with 1+years
• Ability to understand more complex clinical study principles
• Advanced understanding of appropriate technology necessary to analyze clinical study data, generate reports and create presentations, posters and manuscripts
• Experience in team, drug development, and scientific project leadership or related.
• Experience supporting clinical research, drug development and/or function/therapeutic area operations.
• Must have a proven record of successful projects.
• Experience in multi-faceted, broad-based multiple functions/therapeutic areas or clinical functions with in depth knowledge of clinical study issues.
• Ability to appropriately and effectively use resources to complete tasks and meet required timelines.
• Ability to produce work of the highest quality by paying attention to detail
• Must possess good oral and written communication skills

Additional Requirements

• Hybrid onsite 3x/week in Lake County, IL