Interim Medical Monitor in England

Job description

About the Company

Our client is an ambitious biotech developing novel therapies for serious ophthalmic diseases. Their program is entering its first-in-human clinical trial targeting wet age-related macular degeneration (wet AMD).

Role Overview

We are seeking a seasoned freelance Medical Monitor with deep ophthalmology expertise, ideally in wet AMD, to provide medical oversight, regulatory insight, and direct engagement study sites. The role involves close collaboration with investigators, budget teams, and internal stakeholders to ensure subject safety, high-quality data, and efficient trial execution.

This is a hands-on position suited to someone comfortable working in a lean biotech environment and ready to influence decisions from protocol to final report.

Key Responsibilities

• Serve as medical and scientific expert for the FIH ophthalmology study (wet AMD focus).
• Provide ongoing safety monitoring: review adverse events, eligibility queries, and safety data trends.
• Lead medical review of complex inclusion/exclusion cases and protocol deviations.
• Communicate effectively with investigator sites, addressing clinical queries promptly.
• If UK-based, take a leading role in budget discussions and contract negotiations with sites.
• Participate in Safety Management Team (SMT) and Data Safety Monitoring Board (DSMB) meetings.
• Provide strategic input into clinical trial design, protocol development, and amendments.
• Contribute to regulatory filings and submissions, including responding to health authority questions.
• Support medical sections of training materials for sites and study teams.

Qualifications & Experience

• MD or equivalent with expertise in ophthalmology (wet AMD clinical trial experience strongly preferred).
• Track record as Medical Monitor or equivalent role in early-phase ophthalmology studies.
• Experience with regulatory submissions/filings in EU, UK, and/or US.
• Strong understanding of FIH trial conduct, GCP, and ICH guidelines.
• Demonstrated ability to work in fast-moving, small-company environments.
• Excellent communication skills; ability to liaise with global site teams.
• UK-based candidates strongly preferred (for budget negotiation with sites).

Extra information

Status

Open

Education Level

Secondary School

Location

England

Type of Contract

Part-time jobs

Published at

01-09-2025

Full UK/EU driving license preferred

No

Car Preferred

No

Must be eligible to work in the EU

No

Cover Letter Required

No

Languages

English