Consultant, Medical Monitor (MD), Metabolic Phase III Study

Description

Remote

Our client is seeking an experienced physician consultant to serve as Medical Lead supporting a critical phase III clinical program in MASH (Metabolic Dysfunction-Associated Steatohepatitis). The role provides dedicated medical oversight of an ongoing clinical study, with responsibility for aggregate data review, safety surveillance, CRO medical monitor support, and regulatory documentation. This is an execution-focused role within the MASH indication. The Medical Lead will function as an extension of the internal physician team with sponsor ownership of the study, ensuring timely safety assessment, protocol interpretation, and regulatory readiness. This role reports to our client’s VP of Clinical Development.

Due to client requirements, applicants must be willing and able to work on a w2 basis. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance.

Rate: $180.00 to $205.00/hr. w2

Job Number #: JN -102026-109161

Responsibilities

• Provide sponsor oversight and decision support while CRO manages first-line medical monitoring.
• Respond to protocol interpretation and safety-related queries escalated from CRO medical monitors.
• Provide documented medical opinions regarding complex safety cases.
• Review and approve protocol-related clarifications affecting safety oversight.
• Support updates to informed consent forms and protocol amendments aligned with emerging safety data.
• Review region-specific protocol modifications for medical appropriateness.
• Provide medical input and review of safety sections for upcoming regulatory submissions.
• Ensure consistency of safety narratives and aggregate data analyses across regulatory documents.
• Support database lock and study close-out, including batch-level subject review of AEs, concomitant medications, and medical history.
• Perform medical coding review to ensure accuracy and clinical consistency.
• Review and finalize patient safety narratives for inclusion in Clinical Study Reports.
• Provide documented sign-off supporting medical readiness for database lock.
• Collaborate with Clinical Operations, Safety/Pharmacovigilance, and Regulatory teams to ensure alignment on safety interpretation.

Experience Requirements

• MD or DO required from the United States or UK.
• Board certification in a relevant specialty preferred, such as hepatology, gastroenterology, endocrinology, or internal medicine.
• Demonstrated MASH/NASH, liver, and gastroenterology experience.
• Prior biotech or pharmaceutical clinical development experience.
• Experience with medical monitoring and safety review.
• Experience with aggregate data interpretation.
• Experience with regulatory safety reporting, including DSUR, PSUR/PSUSAR, and ASR.
• Experience with database lock review and CSR narrative preparation.
• Ability to work independently in a high-accountability environment.
• Strong communication and presentation skills.
• Nice to have: Experience supporting BLA submission activities.