NADEEM KHALIQ

Strategic Physician Executive with over 20 years of leadership in clinical development and operations within pharmaceutical and CRO sectors. Led multidisciplinary teams in planning and executing complex Phase I–IV clinical programs across various therapeutic areas, ensuring regulatory compliance and quality. Translated scientific strategies into operational success, advancing portfolios and delivering global clinical studies across diverse regions.

Executive leader with deep experience driving organizational success and fostering collaboration. Skilled in strategic planning, financial oversight, and stakeholder engagement. Known for adaptability, resilience, and delivering results in evolving environments. Strong interpersonal skills, effective communicator, and results-driven approach.

• Global Portfolio Leadership: Directed operational strategy and execution for clinical development portfolios with budgets exceeding $200M, ensuring delivery of critical development milestones while maintaining quality, compliance, and fiscal discipline.
• Global Clinical Trial Delivery: Successfully led execution of 70+ multinational Phase I–IV clinical studies from protocol development through database lock and regulatory submission. Implemented proactive risk management, governance frameworks, and performance metrics that improved operational execution, accelerated enrollment, strengthened vendor accountability, and enhanced inspection readiness.
• Worldwide Site Network: Managed clinical programs involving 150+ investigative sites throughout North America, Europe, Asia-Pacific, and Latin America.
• Regulatory Success: Supported multiple INDs, regulatory submissions, and global Health Authority interactions while maintaining compliance with ICH-GCP, and international regulatory requirements.
• Organizational Leadership: Developed and mentored high performing clinical professionals, project leaders, and functional managers while fostering a collaborative culture focused on accountability, innovation, and continuous improvement.

• Neuroscience: Alzheimer’s, Parkinson’s, Multiple Sclerosis, PSP, Stroke, SCI, Epilepsy
• Rare & Ultra-Rare Diseases: LEMS, DMD, PNH, aHUS, HPP, r-MG
• Oncology: Breast, NSCLC, Colorectal, Ovarian, Bladder, Prostate, Basal Cell Carcinoma, Soft Tissue Sarcoma, and other Solid Organ Tumors
• Immunology/Infectious Diseases: Monoclonal Antibodies, Vaccines, RSV, Severe Sepsis
• Stem Cell & Regenerative Medicine: Autologous Adult Stem Cells, Gene Therapy
• Transplant Surgery: Liver, Kidney, Kidney-Pancreas, Islet Cell Transplantation
• Cardiovascular: Angiogenesis with Gene Therapy, Hypertension, Intracranial Hemorrhage, Cardiomyopathy, Stroke
• Metabolic/Renal: Renal Insufficiency, DM, Thyroid Disorders, Adrenal Insufficiency, GHD
• Others: Respiratory, Genitourinary, Gastrointestinal, Hematology, Medical Devices

• Enterprise Leadership: Provided strategic leadership across Clinical Development and Clinical Operations organizations by aligning scientific objectives with operational execution to accelerate development while ensuring quality, compliance, and patient safety. Partnered with executive leadership to establish:
• Clinical development and operational strategy
• Resource allocation
• Operational risk management
• Development timelines
• Executive milestone reviews
• Clinical Development Leadership: Partnered with Clinical Development physicians in:
• Clinical Development Plans (CDPs)
• Study design and Operational feasibility
• Endpoint selection
• Synopsis & Protocol development
• Medical Monitoring
• Investigator & KOL engagement
• Clinical and Scientific presentations
• Clinical Study Reports
• Regulatory submissions (NDA/BLA)

• AbbVie Clinical Development Award (2018)
• Baxter Corporate Development Award (2012)
• PPD CEO Performance Excellence Award (2009)