Clinical Development Medical Director; MD

ROLE SUMMARY

• The Clinician Medical Monitor is accountable for providing medical and scientific expertise and oversight for Clinical Trials and serves as a single point of accountability for design, execution, monitoring, delivery and reporting of one or more clinical studies and to ensure patient safety.
• The clinician medical monitor may be required to design a development strategy for multiple protocols designed to obtain worldwide approval for a compound or group of compounds.
• In addition to study level activities, the clinician medical monitor may participate in standing committees, review compounds for potential in-licensing, including performance of due diligence reviews, and aid new business development on market opportunities and the target product profile.

Accountable for safety across the study

• Provide study team with medical advice for all medical issues during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial, site and patient level.
• Ensures development of and adherence to the Safety Surveillance Review Plan (SSRP).
• Consistent with the SSRP, performs and documents regular review of individual subject safety data, and performs review of cumulative safety data with the safety risk lead.
• As appropriate, the clinician medical monitor may delegate these responsibilities to the study clinician scientist identified in the SSRP.
• The specific components of safety data review are detailed in the appropriate SOPsand the “Safety Data Review Guide – for Clinicians.”
• Monitor study safety issues and provide input to serious adverse events (SAEs) reports.
• Provides appropriate medical context in terms of risk factors, medical history and other important medical factors required to put the SAE or AE into appropriate medical context required for benefit-risk assessments.
• Participates in the Safety Review Team to evaluate medical benefits/risks to support targeted clinical indications.
• Reviews literature as needed to respond to safety questions or those posed by the Safety Review Team, Data Monitoring Committee (DMC) or other individuals or bodies involved with the study.
• Communicates safety information to sites across the study and provides responses to questions on safety.

• Provide medical input during development and updates to the clinical development plan.
• Designs clinical studies to meet the stated objectives. Assures that clinical trial objectives fit with the clinical program strategy.
• Ensure that documents (protocol, Informed Consent Document [ICD], etc.) meet regulatory requirements and company policy and has been reviewed by IRB/IECs.
• Provides medical input into country feasibility.

Support study team

• Provides clinical input to protocol/study team for monitoring guidelines, statistics analysis plans, ICDs, clinical review forms, data edit checks, data quality planning, as needed (ultimately oversees work of protocol/study team).
• Contributes to contract research organization / vendor selection to ensure study is conducted consistent with protocol requirements, clinical plan expectations, and study timelines; this includes ensuring medical/technical requirements for data integrity are applied.
• Works with study team to ensure high quality of data e.g., appropriate patient population, adequacy of clinical assessments as study is ongoing.
• Conducts medical review and interpretation of efficacy and safety data from clinical trials; this may include delivery of top-line report in collaboration with study statistician, and delivery of clinical study report in collaboration with medical writer and accountable for overall quality and timeliness of analysis and reporting.
• Ensures the medical and scientific validity…