Consultant, Medical Monitor (MD), Metabolic Phase III Study
Anywhere
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
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.
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.
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Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. Eliassen Group’s Affirmative Action Plan (AAP) is available for inspection by any employee or applicant for employment upon request, during normal business hours of Monday through Friday, 8:30am to 5:30pm EST. Interested persons should contact Phaedra Wells at pwells@eliassen.com for assistance. It is unlawful in Massachusetts and Maryland to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Applicants with disabilities that believe they require an accommodation or assistance with a position, please email our HR team at hradmin@eliassen.com. This email inbox is designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Emails sent for other purposes will not receive a response.
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Unfortunately, fraudulent job postings can happen. If anyone reaches out to you about an open position connected with Eliassen Group, never provide personal or financial information to anyone who is not clearly associated with Eliassen Group
If anyone seemingly from Eliassen Group has ever requested this personal information in the past or does so in the future, please contact fraud@eliassen.com.
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, as indicated above