Malik A. Email & Phone Number

• Led cross-functional teams in the execution of clinical trials, fostering collaboration between clinical research associates, data management, regulatory affairs, and pharmacovigilance for an oncology Phase I clinical trial partnership.• Developed and implemented detailed project plans outlining timelines, milestones, resource allocation, and risk mitigation strategies, ensuring alignment with client goals and regulatory guidelines of ICH-GCP. • Monitored project budgets and timelines, identifying and proactively addressing potential deviations to maintain project efficiency and cost-effectiveness.• Oversaw the selection, negotiation, and management of third-party vendors, ensuring timely delivery of services in line with project objectives and budget constraints; executed contracts and managed ongoing vendor relationships to maintain high-quality trial support services.• Supported the preparation and transmission of expedited and aggregate safety reports.• Facilitated high quality communication between internal and external stakeholders, including pharma client, investigators, and regulatory bodies, providing timely updates and addressing inquiries.

• Supported project management efforts of multiple global clinical trials concurrently, ensuring efficient allocation of resources, risk mitigation, and achievement of key milestones within budget and time constraints.• Collaborated with clinical, regulatory, and safety teams to align on trial objectives, protocols, and deliverables• Assisted CRAs by monitoring site performance, ensuring compliance with protocols and regulatory requirements, managing site communications, and supporting site initiation, monitoring visits, and close-out activities to ensure smooth trial progression.• Generated study reports, identified issues and risks, and contributed to action planning per project SOPs • Developed strong relationships with KOLs and investigators, providing scientific support and addressing clinical inquiries to facilitate study participation and collaboration.

Lexington, Kentucky, United States

• Part of founding team for startup producing a Delta-8 beverage • Executed stress testing for products and drafted quality control measures for production of over 50,000 cans under cGMP protocols• Amplified sales through negotiation of distribution contracts in TN and KY

• Received summer fellowship to do research in pharmacology and nutritional sciences under the guidance of Dr. Terry Hinds• Conducted pharmacology projects with MEF and COS7 cells, and then human prostate cancer cell lines• Developed understanding of transfection and transformation assays, promotor cloning, RT-PCR, RNA extraction, and DNA Extraction• First author on literature review manuscript developed at this lab

Lexington, Kentucky, United States

• Formulated new CBD products for consumer use including transdermal patches, kinesiology tape, water soluble • Facilitator of partnership with Midway university on a palatability study for equine CBD products • Consulted clients on current literature of cannabinoid research

- Conducted research projects in neuropharmacology under the guidance of Dr. Keith Pennypacker, PhD- Performed experiments to aid in discovering more effective treatments for brain damage after stroke - Developed understanding of lab techniques such as ELISA, flow cytometry, Western Blot, mouse models, and animal surgery- Presented several deliverables to academic faculty and peers during summer fellowship- Developed and presented research poster from this work

University Of Kentucky

- Conducted research projects in Equine Sports medicine under the guidance of Dr. James MacLeod, VMD PhD- Developed understanding of mammalian tissue culture, histology, staining and paraffin embedding, and cell signaling pathway inhibition- Further refined data analysis skills through creation of a transcribed gene library in Microsoft Excel

Doctor Of Pharmacy - Pharmd, Pharmacy

Master Of Business Administration - Mba

Education record

Master Of Business Administration - Mba