The Medical Director, Clinical Safety is responsible for providing medical safety expertise for the benefit/risk assessment of products in clinical development, with a focus on nemolizumab and the Prurigo Nodularis indication.  This position is accountable, in a matrix organization, for the benefit/risk activities concerning the clinical development portfolio (with a focus on nemolizumab) including signal detection, risk management, risk mitigation/management plans, safety analyses in aggregate reports.  This position is also responsible for the medical review of safety-related information in study protocols, study reports, investigator brochures, product labeling, aggregate reports, and responses to specific questions from health authorities.

 

The Medical Director, Clinical Safety will line manage a team of PV staff in different locations focused on clinical development PV activities across the development portfolio.

 

Essential Functions

·         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 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 diligences, 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
• Ensure effective collaboration with the Global Rx Business Unit, Clinical Development group, and other internal stakeholders

·         Manage a team, including workflow, performance reviews and training

• Other duties as assigned

Minimum Education, Knowledge, Skills, and Abilities

·         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 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

·         Experience in analyzing and managing significant safety issues across product life cycle with a focus on drugs in clinical development

·         Ability to identify risks and propose mitigation actions in complex and critical situations

·         Ability to work with a cross-functional team and achieve deliverables within agreed timelines

·         Ability to work independently, to manage stress, and to adapt in a fast-changing business environment

·         Ability to communicate key concepts and proposals to senior management in a clear and effective manner

·         Fluent in English, required