Senior Manager, Internal Medicine, Clinical Scientist (Ophthalmology)

About This Role

This Senior Manager, Clinical Scientist, will lead the development, evaluation, planning, and execution of clinical studies, ensuring the integrity and interpretation of study data within a clinical development program. The role involves contributing to candidate development projects in a cross-functional matrix environment, focusing on early and/or late-phase development.

Responsibilities

• Contribute to program team meetings, scientific advisory boards, study steering committees, and data/safety monitoring meetings
• Develop and maintain understanding of therapeutic disease area(s), drug candidates, underlying disease biology, clinical manifestations, standard practice, compound mechanism of action, and drug landscape
• Apply scientific expertise to support initiation and execution of clinical research and development studies for early and/or late-stage assets
• Assist with development of the Expanded Synopsis and author/review clinically relevant sections of clinical trial protocols and amendments
• Assist with and author/review documents related to trials, including medical monitoring plans, SAPs, informed consents, and clinical components of Clinical Study Reports
• Maintain compliance with FDA, EMEA, ICH, and GCP guidelines, as well as applicable SOPs regarding clinical safety
• Perform clinical/medical data review, including safety monitoring and activities ensuring patient safety
• Collaborate with internal functions and external vendors to promote clinical study integrity
• Exhibit strong analytical knowledge and skills to understand how study objectives and design impact data analysis
• Promote consistent first-line medical/clinical data review techniques and conventions across assigned studies

Requirements

• BS/MS/PhD/PharmD in a related field
• 8 years of pharmaceutical clinical drug development experience
• Experience in Ophthalmology clinical trials
• Proven knowledge of the drug development process
• Knowledge of Good Clinical Practice (GCP)
• Knowledge of study design, clinical research methodology
• Medical writing skills
• Knowledge of regulatory requirements and ICH/GCP guidelines
• Proven track in clinical trial process improvements
• Considerable organizational awareness, including significant experience working cross-functionally

Qualifications

• BS/MS/PhD/PharmD in a related field
• 8 years of pharmaceutical clinical drug development experience, specifically in Ophthalmology clinical trials.

Benefits