The Medical Monitor responsibilities include supporting clinical development activities across Phase 2 and Phase 3 programs, with emphasis on the evaluation, interpretation, and review of clinical data, identification and assessment of safety signals, and preparation of key clinical documentation. The consultant will collaborate closely with cross-functional stakeholders including Clinical Development, Clinical Operations, Biometrics, Regulatory Affairs, Pharmacovigilance, and external CRO partners to support the conduct, analysis, and reporting of clinical studies and associated regulatory deliverables.
Key Responsibilities:
Clinical Development & Program Support

• Provide medical and scientific expertise across development programs in partnership with internal teams and external CRO collaborators
• Assist with the interpretation and review of clinical safety and efficacy data to support development decisions and regulatory activities
• Participate in cross-functional clinical development discussions and contribute to strategic planning activities as appropriate

Data Review & Analysis

• Review and evaluate clinical trial data outputs, including tables, listings, and figures
• Support medical data review, data cleaning efforts, and resolution of data-related issues in collaboration with internal teams and CRO partners
• Contribute to safety and efficacy analyses, including exploratory and post hoc evaluations when applicable

Regulatory & Clinical Documentation
Support the drafting, review, and finalization of clinical and regulatory documents, including but not limited to:

• Protocols
• Clinical Study Reports (CSRs)
• Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE)
• Investigator’s Brochure (IB) updates
• DSURs and other safety-related compound documents
• Clinical sections of regulatory submissions and briefing materials
• Prepare and/or review study narratives and assist with narrative quality review in support of submission readiness
• Study Design & Conduct
• Assist in the development, review, and revision of study-related documentation, including:
• Clinical protocols and amendments
• Informed consent forms
• Statistical analysis plans (in collaboration with Biometrics)
• Clinical trial execution plans and supporting materials
• Provide medical guidance regarding protocol interpretation and study conduct throughout trial execution

CRO & Vendor Collaboration

• Act as a medical and clinical development liaison for CROs and external vendors
• Participate in routine meetings with CRO teams to address protocol questions, data review findings, and operational study issues
• Support oversight of CRO-generated deliverables related to clinical data review, reporting, and regulatory submissions

Safety & Pharmacovigilance Support

• Participate in Safety Review Team meetings and collaborate with Pharmacovigilance colleagues as needed
• Review safety information and contribute to the assessment of emerging safety signals
• Provide medical input into safety documentation and benefit-risk evaluations
• Engage promptly with investigative sites when Serious Adverse Events (SAEs) occur to ensure timely communication and management in accordance with applicable procedures
• Additional Responsibilities
• Support the preparation and review of program-level and cross-functional clinical documents as needed
• Provide ad hoc medical and clinical development support for regulatory activities, internal reviews, and inspection readiness initiatives

Experience Required

• Physician with a minimum of 6+ years of experience in drug development
• Prior experience in Psychiatry or Neurology is required

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Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.

At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.

Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact [email protected].