Play an active role in planning, conduct and evaluation of ongoing clinical trials to ensure successful execution
Serve as Medical Monitor for assigned clinical trials
Support/manage preparation of materials for trial-related clinical committees
Contribute to planning, authoring, and critical review of documents submitted to regulatory authorities
Contribute to the strategic planning, authoring, and critical review of scientific data disclosures
Develop professional relationships with external clinical opinion leaders, investigators, and consultants
Contribute to engagement with external stakeholders
Function as an independent member of the team and represent clinical development at internal cross-functional or external meetings
Other duties related to clinical development as assigned

Requirements

Board Certified MD or MD/PhD or equivalent qualification with relevant medical experience
Experience in hepatology, MASH or internal medicine preferred
Minimum of 3 years of relevant experience in clinical development in the biotech and/or pharmaceutical industry; five (5) years preferred
Direct experience in executing Phase III clinical trials, including medical monitoring responsibilities
Solid knowledge of GCP, ICH guidelines and FDA/EMA/CHMP regulations
Proven experience authoring or overseeing regulatory documents
Strong interpersonal and communication skills
Skilled at searching, critically evaluating, interpreting and synthesizing scientific literature and clinical trial data
Demonstrated problem-solving ability and ownership of issues
Comfortable working independently and as part of cross-functional teams
Highly organized with strong prioritization and time-management skills
Advanced proficiency in Microsoft Office (Word, Excel, PowerPoint)
Experience with preparation of documentation for BLA/NDA/MAA submissions desirable
Knowledge of the regulatory path across the various health authorities (FDA, EMA etc) desirable
Experience in Hepatology, Gastrointestinal, Endocrinology or related field, preferred.

Benefits

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical trialsmedical monitoringregulatory documentsGCPICH guidelinesFDA regulationsEMA regulationsBLA submissionsNDA submissionsMAA submissions

Soft Skills

interpersonal skillscommunication skillsproblem-solvingindependenceteam collaborationorganizational skillsprioritizationtime-managementcritical evaluationsynthesis of data

Certifications

Board Certified MDMD/PhD