Khalid Mamun

About Khalid Mamun

With over 25 years of experience in the pharmaceutical industry, I am a seasoned leader with expertise in investigator initiated trials, observational research operations and late phase interventional trials. I develop and implement best-in-class frameworks and processes that enable teams to deliver innovative and high-quality research while meeting strict safety and regulatory standards. Currently, I lead the R&D strategic initiatives at Genmab, a global biotechnology company that specializes in antibody therapeutics for cancer.In my previous roles at Amgen, I orchestrated the global observational research operations and transitioned the Otezla medical affairs portfolio following a divestiture. I also initiated the first pragmatic trial in acute coronary syndrome, a novel and complex study that required new processes and vendors. I am passionate about developing teams and facilitating research that saves lives and improving health outcomes for patients worldwide. I leverage data analytics, strategic planning, risk mitigation, and cross-functional collaboration to drive change and innovation in the field.

Experience

1. Observational Research Director - Clinical Program Operations-observational Research

   Amgen

   Oct 2020 — Present · NJ, US

   In my current role, I orchestrate observational research operations globally with ownership of process development, strategic planning, risk mitigation, and outsourcing. I seward outsourcing portfolio and other phase 4 studies and ensure full alignment with strategy, qualification, and performance oversight mandates.• Initiated first pragmatic trial (EVOLVE-MI) in acute coronary syndrome.• Developed completely new processes and worked with new vendors to enable novel study.• Authored SOPs, manuals, training material, and cross-functional workstreams.

Education

• Marymount Manhattan College

  BS, Biology

  1993 — 1996

• Harvard Medical School

  HMX Pro Pharmacology online certificate program - Clinical Drug Development

• Rutgers University

  Mini MBA, Health Policy Excellence

• Harvard Medical School

  HMX Pro online certificate program - Immunology-Immuno-Oncology

Skills

• Good Clinical Practice (Gcp)
• CRO Management
• Oncology
• Protocol
• Ctms
• Clinical Trials
• Research
• Pharmaceutical Industry
• Sop
• Fda
• Planning
• Biotechnology
• Budgets
• Clinical Monitoring
• Clinical Trial Management System (Ctms)
• Standard Operating Procedure (Sop)
• Budgeting
• Clinical
• Data Management
• Drug Development
• Cancer
• Gcp
• U.s. Food and Drug Administration (Fda)
• Life Sciences
• Dermatology
• Strategic Planning
• Immunology
• CRO
• Clinical Development
• Pharmaceuticals
• Medical Writing
• Negotiation
• Clinical Research
• Pharmacovigilance