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Smiling employee in a conversation with a colleague in the office
ID: 000172

Executive Clinical & Medical Safety Consultant

  • Pharma & Biotech
  • Asap
  • Global Clinical Development, EU/UK QPPV, CAR-T
  • K-Recruiting GmbH
Contact:

Julius Strack

+49 89 1890998-614

julius.strack@k-recruiting.com

Overview

Availability
Asap, 5 days/week, on-site & remote
Qualification
PhD qualified Oncologist
Language Skills
Hungarian (native), English (business fluent)
Relevant Expertise
Medical Consultant, Commercialization, Global Clinical Development, Medical Monitoring & Reviews, EU/UK QPPV, CAR-T, Cell Therapy, Hematology, Immuno-Oncology, Biotech

Key-Facts

  • 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

Extract from previous activities

Biotech Company, USA

Executive Clinical & Medical Safety Consultant

  • 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

Biotech Company, USA

Senior Medical Safety Consultant

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

Pharmaceutical Company, France

Executive Medical Safety Consultant, Oncology & Biologics

  • 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