Global Head of Clinical Safety
Galderma Barcelona, Spain
Job Description
As the Global Head of Clinical Safety, you will be responsible for providing medical safety expertise for the benefit/risk assessment of products in clinical development, with a specific focus on our key biologic (Nemolizumab). This involves signal detection, risk management, risk mitigation/management plans, safety analyses in aggregate reports, providing input into publications and data dissemination activities and managing the PV relationship with a key business partner.
This position is also responsible for the medical review of safety-related information in study protocols, study reports, investigator brochures, product labelling (including CCDS), periodic/aggregate reports, risk management plans and responses to specific questions from health authorities.
The Global Head of Clinical Safety will line manage a team of pharmacovigilance (PV) staff in different locations around the world who are focused primarily on clinical development PV activities across the development portfolio but which will increasingly involve some post-marketing surveillance and lifecycle management activities as well.
This role will have a significant degree of autonomy and will be highly visible within the organization with broad exposure to senior management. You will have the opportunity to make a meaningful positive impact on the lives of patients and consumers who suffer from a variety of dermatological conditions and to live the Galderma vision which is "Advancing dermatology for every skin story".
The role reports to the Global Head of PV Risk Management
Key Responsibilities
- Propose and recommend measures aiming at minimizing risks during clinical development; release and update the Development Risk Management Plans (DRMPs);
- Partner with internal and external stakeholders to ensure monitoring of safety profile for assigned compounds, signal validation and signal evaluation, and propose appropriate risk management and risk minimization measures;
- Take ownership of aggregate safety reports (e.g. DSUR, PSUR, PBRER);
- Take ownership of (development) Risk Management Plans (RMP);
- Provide input into safety modules for dossier submission and contribute to answers to safety-related questions from regulatory agencies and internal/external stakeholders;
- Contribute to investigator/KOL meetings for safety-related aspects/questions;
- Contribute to IDMC (Independent Data Monitoring Committee) meetings, and support due diligence activities, as needed;
- Lead ongoing safety data review during clinical trials through Safety Plans and safety review meetings;
- Escalate and present safety issues at company governance bodies;
- Contribute to compliance and PV inspection/audit-related activities;
- Ensure effective collaboration with Global Regulatory Affairs, Global Medical Affairs, the Clinical Development group, Commercial and other internal stakeholders;
- Line manage a team of up to 5 direct reports.
Skills & Qualifications
- Doctor of Medicine (M.D.) required;
- Additional degree in Clinical Pharmacology and/or Pharmacovigilance/Drug Safety and/or Public Health and/or epidemiology, preferred;
- 12 years of global experience in Drug Development, Clinical Safety, or Pharmacovigilance in a global pharmaceutical company in a matrix organization is required;
- Minimum 3 to 5 years of line management experience of a team of Safety Physicians and/or Scientists is required;
- Significant experience and knowledge of international clinical development and post-marketing regulations applicable to drugs. Knowledge of regulations and industry best practice for development of biologics is required;
- Interactions to address safety medical questions related to clinical studies (e.g. Summary of Clinical Safety, Clinical Overview, RMP) with health authorities in the US, EU and other geographies required;
- Sound knowledge of the global pharmacovigilance and safety requirements for non-clinical and clinical development, registration process and post-marketing, required.
