Dr. MALATHESH JK

THERAPEUTIC AREAS - ONCOLOGY (solid tumors, advanced head and neck squamous cell cancer, gastric adenocarcinoma, pancreatic cancer, NSCLC, prostate cancer, hematology-MDS), PULMONOLOGY (PAH), CARDIOLOGY (left atrial appendage closure system).

• Responsible for medical data review and medical safety activities.
• Involved in activities ranging from study start-up to close-out activities.
• Involved in bid defense meetings.
• Involved in the clinical trial feasibility report (medical part).
• Involved in medical monitoring activities such as the review of AE/SAEs/AESIs/ADRs/special situations, the review of coding medications (WHODD), AE/SAEs (MedDRA) to support the data management team, handling medical queries, PDs, and quarterly monitoring of SARs.
• Medical review of SAEs (ICSRs) in Argus ensures the reporting of SAEs according to applicable regulations and sponsor requirements for all CT cases, including drafting AOSEs for SUSAR cases.
• Perform an eligibility review.
• Involved in the review of medical listings—AE, CM, MH, PR, etc.—and maintaining the medical query tracker, aggregating the review of patient profiles, and reviewing lab alerts.
• Perform a coding review of adverse events, medical history, concomitant medications, concomitant procedures, and other medical data listings for accuracy and consistency.
• Preparation of the MDR guide, Medical Monitoring Plan (MMP), Safety Management Plan (SMP), Safety Trend Analysis Report (STAR) using the QlikSense platform, Power BI, and Spotfire, Safety Review Committee (SRC) slides, Data Safety and Monitoring Board (DSMB/DMCs) slides, etc., and present in sponsor meetings, contribute to protocol development, and study design.
• Present in monthly medical hours, clinical data view (CDV) meetings, and team meetings.
• Collaboratively work with Data Managers (DM), Clinical Scientists (CS), Therapeutic Medical Advisors (TMA), Statistical Programmers (SP), Regulatory Affairs (RA), and Clinical Project Managers (CPMs).
• Provide therapeutic area, indication training for the project clinical team.
• Serve as a Subject Matter Expert (SME).

Therapeutic Areas: Vaccines, Oncology, Immunology, Cardiology. Worked on 4 projects:

• AstraZeneca (AZD1222 COVID Vaccine)

• Merck Serono Project (15 oncology protocols)

• Kowa PROMINENT Project (Cardiology protocol).

• MedPacto (2 Oncology protocols)