Clinical Scientist Associate Director – Early Development, Inflammation

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in the setup and execution of early-phase clinical trials with an emphasis on data integrity.

• Contribute to the drafting of clinical protocols, Investigators' Brochures, and other regulatory documents to ensure clarity and consistency.

• Offer insights into and assist with the implementation of the data management plan, CRF design, and data review oversight.

• Aid in the review, analysis, and preparation of presentations related to clinical trial data for internal decision-making, external communications, and regulatory submissions.

• Support the management of collaborators, consultants, and/or Clinical Research Organizations in the completion of significant projects.

• Proactively identify and manage issues across a wide range of cross-functional teams.

• Collaborate across teams to ensure that the clinical strategy is effectively translated into the development of the study concept document, study protocol, and related documents.

• Assist in the training, recruitment, and development needs for matrix team resources.

⛳️ Requirements

• Doctorate degree and 3 years of clinical development experience OR Master’s degree and 5 years of clinical development experience OR Bachelor’s degree and 7 years of clinical development experience OR Associate’s degree and 12 years of clinical development experience OR High school diploma / GED and 14 years of clinical development experience.

• 3 years of experience in a pharmaceutical industry environment with at least 1 year supporting early or late-phase clinical development in a relevant therapeutic area or disease indication.

• Proven experience in contributing to clinical trial process enhancements within a therapeutic area or study team setting.

• Familiarity with supporting the design, monitoring, and implementation of clinical trials in line with Good Clinical Practice standards and applicable regulatory requirements.

• Working knowledge of study data readout activities, including data cleaning, database locking, data extraction, and generating clinical data outputs.

• Experience in contributing to regulatory submission documents and assisting with clinical regulatory responses for health authority interactions under guidance.

• Experience serving as a contributing author on scientific publications or data presentations for internal forums or scientific conferences.

• Experience in clinical data analysis using tools such as Spotfire or other data analysis software.

🏝️ Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions.

• Group medical, dental, and vision coverage.

• Life and disability insurance.

• Flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Flexible work models where possible.