Medical Director Clinical Safety
$1 to $2 Per Year
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.
· Propose and recommend measures aiming at minimizing risks during clinical development; release and update the Development Risk Management Plans (DRMPs)
· Manage a team, including workflow, performance reviews and training
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
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