Executive Clinical & Medical Safety Consultant

Ph.D. qualified Oncologist with over 30 years of international experience in pharmaceutical medicine, clinical practice, and medical research, specializing in clinical development and pharmacovigilance

Expert in global drug development, from first-time in human trials to in-market management, with successful product submissions and approvals in the UK, EU, USA, Australia, and Japan

Proven leader in signal detection, benefit-risk assessment, and risk management, with a strong ability to recognize safety data trends and targeted toxicities for global products

Led program developing next-generation CAR-T cell therapies involving differentiated & clinically validated CD22 CAR in B-cell malignancies designed to achieve superior efficacy by pre-empting key drivers of drug resistance

Provided Medical Monitoring and Safety support for Phase 1 & 2 clinical trials with CD22-directed autologous CAR- Tcell therapy in relapsed/refractory large B-Cell lymphoma after CD19-directed CAR T-cell therapy

Supported all medical & PV aspect for products in various stages of clinical development through their lifecycle

Instrumental in forming clinical development plan of the asset and in the building of PV system/department

Acted as medical Monitor and Safety Strategy Lead for two Phase 1 studies investigating combination autologous CAR-T Cell Therapy in hematologic malignancies

Provided PV and risk management expertise to internal & external customers, safety expertise for assigned key strategic products, inputs for cross-functional Safety Management Teams, GPV internal Safety Analysis Teams

Lead MAA submission activities (FDA, EU, UK) for key strategic oncology products. Drafted support documentation as required to external partners, key opinion leaders, Health Authorities during internal and external negotiations

Supported due diligence activities and pharmacovigilance agreements for Oncology Biologics products

Provided support and insight for the preparation of clinical developments, protocols, IB, CSR reviews

Lead signal detection and analysis process methodologies and interpretation analysis of the results for products

Collaborated with Centre of Excellence for Risk Management and Safety Epidemiology

Lead benefit-risk assessment cross-functionally, prepared risk management strategies and plans and monitored effectiveness of risk minimization measures. Provided inputs to the safety management plan when required

Approved and validated reports: e.g., RMP, IND Annual Report, Annual Safety Report/DSURs/PSURs/PBRERs, etc.

Served as the medical safety expert to the GPV Periodic Reports group for assigned products.

Lead aggregate safety data review activities and coordinated safety surveillance activities