Seasoned biopharmaceutical industry professional with progressive expertise in across the full clinical development lifecycle (Phases I-IV), spanning site management, clincal trial execution, oversight and inspection readiness. Deeply experienced in GCP, ICH E6, Health Canada Division 5, and FDA regulatory frameworks. 

My work centers on the oversight of TMF completeness, site performance, and deviation management, with a strong emphasis on ensuring studies are not only inspection-ready but operationally  resilient and defensible under regulatory scrutiny.

I am particularly focused on how operational signals, including documentation completeness, monitoring timelines and protocol deviations can be systematically leveraged to anticipate and mitigate risk earlier in the trial lifecycle. 

My current work explores how these signals interact, compound and translate into inspection outcomes, with the goal of moving from reactive compliance to predictive quality and proactive risk management.

I am always open to engaging with peers and industry leaders on clinical operations, quality strategy and innovation in trial execution. 

• Atrial Fibrillation (device)
• Heart Failure
• Hypertension
• Sarcoidosis Associated Pulmonary Hypertension

• Atopic Dermatitis
• Psoriasis

• Crohn's Disease
• Dyslipidemia
• Diabetes
• Hepatitis C
• Irritable Bowel Syndrome (IBS)
• Obesity
• Ulcerative Colitis

• Acquired Hemophilia

• Huntington's Disease
• Parkinson's Disease

• Bladder Cancer
• Breast Cancer 
• Chronic Lymphocytic Lymphoma (CLL)
• Colorectal Cancer
• Multiple Myeloma
• Non-Hodgkin Lymphoma
• Non-Small Cell Lung Cancer (NSCLC)
• Prostate Cancer

• Duchenne Myelopathy

• Asthma
• Chronic Obstructive Pulmonary Disease (COPD)
• Respiratory Syncytial Virus (RSV) Vaccine

• Ankylosing Spondylitis 
• Lupus
• Psoriatic Arthritis
• Rheumatoid Arthritis (pediatric and adult population)

• English (Native or Bilingual Proficiency)
• French (Native or Bilingual Proficiency)
• Spanish (Professional Working Proficiency)
• German (Elementary Proficiency)