Medical Director, Global Patient Safety

About the role

Alexion is looking for a Medical Director, Global Patient Safety (GPS) to lead safety and risk management for one or more assigned clinical development projects or marketed products. The role is accountable for the safe and effective use of Alexion's products by patients and healthcare providers, and sits under the supervision of the Global Safety Program Lead.

Key responsibilities

• Lead risk management evaluation and resolution for assigned products and projects, including safety signals, risk management and risk/benefit decisions.
• Own the scientific and clinical safety content for assigned assets or indications, set safety team goals aligned to therapeutic area and product strategy, and define safety TPP, go/no-go criteria, safety messaging and toxicity management guidelines.
• Ensure high-quality delivery of the Safety & Strategy Management Team and Safety Surveillance Team for assigned assets.
• Contribute to study designs and concepts, chair or direct the Safety Management Team from inception to closure, and represent Alexion at internal committees, DSMB or regulatory authority meetings.
• Detect, validate and manage pre- and post-approval safety signals through to resolution.
• Evaluate aggregate safety data and contribute to Periodic Safety Update Reports, Drug Safety Update Reports, Risk Management Plans and other safety documents.
• Initiate and manage updates to the IB, CCSI, Medication Guide, Patient Leaflet and other labeling, and oversee safety sections of documents and interactions with regulators.
• Analyse clinical safety data robustly and act as a safety knowledge source for the Product Team.

Required profile

• MD or equivalent degree, or a life sciences/pharmacy/nursing degree, with demonstrated patient safety and/or clinical drug development experience.
• Preferred: 2-3 years of safety and risk management experience in pharma, biotech or CRO, and rare, ultra-rare or orphan disease experience.
• Knowledge of US and EU safety regulations pre- and post-marketing, and of GPS deliverables, standards and processes.
• Ability to manage multiple complex projects to tight deadlines and to make sound, independent decisions.

Required skills

• Strong verbal and written communication, including advising management and senior leaders.
• Project management and time management skills.
• Mastery of Microsoft Word, PowerPoint and Excel.