CSG Talent
Senior Medical Director, Ophthalmology Clinical Development
CSG Talent, Denver, Colorado, United States, 80285
Overview
We are seeking a Senior Medical Director to play a pivotal role in advancing our clinical programs in ophthalmology. This remote position allows you to lead high-impact trials while collaborating with dedicated teams focused on innovation and improving patient outcomes.
What You'll Do
Lead the design, execution, and reporting of clinical studies (Phases I-III) through NDA submission.
Serve as Medical Monitor, providing oversight for safety reviews, endpoint development, and patient selection.
Oversee the creation of critical clinical documents including protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions, and presentations.
Collaborate with Clinical Operations, Data Management, and external stakeholders to ensure successful trial outcomes.
Represent Clinical Development in cross-functional teams, regulatory meetings, and interactions with Key Opinion Leaders (KOLs).
What We're Looking For
MD required; a background in ophthalmology is preferred.
Minimum of 2 years’ clinical development experience in biotech or biopharma.
Extensive knowledge of FDA guidelines, Good Clinical Practice (GCP), and regulatory requirements.
Experience in developing protocols, study reports, and submissions.
Outstanding communication, collaboration, and leadership skills.
Ability to excel in a fast-paced, remote work environment.
Willingness to travel up to 25% as required.
This position offers the chance to join a team that emphasizes creativity, collaboration, and innovation while working remotely anywhere in the US.