Medical Director/Medical Monitor (MD/MM) works closely with the clinical operations team to provide medical expertise and safety oversight for all clinical trials. This role involves engaging with clinical research organizations (CROs), clinical site investigators, and serving as the main point of contact for the Sponsor. Additionally, the MD/MM participates in the development and review of clinical trial protocols and documents and supports the overall clinical strategy.
Key Responsibilities:
- Provide comprehensive regulatory, ethical, GCP, and medical evaluations for critical documents such as protocols, informed consent forms, and investigator brochures for both planned and ongoing clinical trials, ensuring effective, compliant study execution and safety oversight.
- Collaborate with study teams to ensure accurate, timely, and complete adverse event reporting to regulatory and oversight bodies like the FDA and IRBs.
- Conduct safety reviews of investigational products and assist in preparing technical and regulatory documentation.
- Serve as the Sponsor's Medical Monitor and oversee medical safety for clinical trials conducted under FDA INDs and ex-US regulatory bodies.
- Review and interpret clinical data in real-time, participate in report reviews, teleconferences, and work with scientific research, biostatistics, and data management teams as needed to ensure participant safety.
- Assess serious adverse event reports from clinical sites to determine if an IND Safety Report is required.
- Work with investigators to oversee and approve safety information submissions to regulatory authorities.
- Ensure compliance with regulatory safety reporting requirements for both domestic and international clinical trials, in collaboration with Regulatory Affairs.
- Assist in the preparation of INDs and IND Annual Reports related to clinical safety data.
- Provide expert consultation to investigators and study teams on protocol procedures concerning safety and regulatory compliance, including population selection, safety testing, adverse event reporting, and informed consent.
- Serve on project teams to advise on safety-related issues.
Requirements:
- M.D. or D.O. degree from an accredited institution in a biomedical or life science field.
- At least 5 years of experience as a Principal Investigator (PI) or Medical Monitor (MM) in clinical research, with a preference for vaccine experience.
- Valid U.S. medical license and board certification in a relevant specialty.
- Knowledge of vaccine safety within the pharmaceutical industry, academic settings, or vaccine-related clinical research.
- Familiarity with pharmacovigilance, clinical safety regulations, clinical research methodology, trial design, and implementation.
- Understanding of U.S. FDA regulations, ICH/GCP guidelines, NIH human research protections, and clinical trial management.
- Strong communication skills for interaction with internal teams and external CRO/vendor staff.
- Ability to make informed decisions, interpret policies, and lead complex clinical trial planning and evaluation tasks.
- Capacity to identify problems and propose effective solutions independently.
- Skilled in interpreting and synthesizing scientific and medical data from various sources.
- Experience in preparing scientific manuscripts for publication and delivering presentations at professional meetings.
- Willingness to travel domestically and internationally as required for site visits and meetings.
