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

Anywhere

Type: Contract

Category: Clinical Ops

Industry: Life Sciences

Workplace Type: Remote

Standard Hours: Open

Reference ID: JN -102026-109161

Date Posted: 10/21/2026

Shortcut: http://careers.eliassen.com/SVy5m3

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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

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.

_Recruitment Transparency Notice_

_Eliassen Group values transparency in our recruitment practices. Please be advised that Eliassen Group utilizes artificial intelligence (AI) tools as part of its initial application screening_ _and hiring_ _process. You may receive email and SMS notifications from the Eliassen Virtual Recruiting Team (_ _noreply@eliassen.com_ _, 781-808-2924) inviting you to complete a brief voice screening as part of your application process. These tools assist our hiring teams in different ways, including but not limited to, assistance in reviewing application materials to help identify candidates whose qualifications most closely match the requirements of the position. All AI-assisted evaluations and responses are reviewed by human recruiters before any hiring decisions are made. The use of AI in our process is intended to support fairness, efficiency, and consistency, and Eliassen Group takes measures to prevent bias or discrimination in connection with its hiring practices. By proceeding, you acknowledge, agree, and consent to Eliassen Group's use of these tools, including AI tools, as part of the application and hiring process._

_Skills, experience, and other compensable factors will be considered when determining pay rate. The pay range provided in this posting reflects a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range._

_W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick time if required by law in the worked-in state/locality._

_If anyone reaches out to you about an open position connected with Eliassen Group, please ensure that you are working directly with us by confirming the following:_

_· When you work with Eliassen Group, all email communication will come from an Eliassen.com address, never Gmail, Yahoo, etc._

_· Eliassen Group will never ask you for personal information (home address, bank account, or check routing number) until you have worked with someone clearly associated with Eliassen Group._

_If you have any indication of fraudulent activity, please contact_ _fraud@eliassen.com_ _._

_About Eliassen Group:_

_Eliassen Group is a strategic consulting firm that helps organizations reach further and achieve more through our technology, business advisory, and life sciences solutions. For nearly 40 years, we have combined exceptional people, deep domain expertise, and intelligent capabilities to expand our clients' capacity and accelerate meaningful outcomes. We are driven by a purpose to positively impact the lives of our employees, clients, consultants, and the communities we serve._

_Eliassen is committed to building a diverse and inclusive team from a variety of backgrounds, perspectives, and skills. We are an Equal Opportunity and Affirmative Action Employer and all employment decisions are based on merit, performance, and business needs. Eliassen does not discriminate on the basis of race, color, gender identity or expression, sexual preference or orientation, sex (including pregnancy, childbirth, and related medical conditions), marital status, creed, religion, physical or mental disability, genetic information, military ...

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