Medical Director, Global Patient Safety

The Medical Director Global Patient Safety (GPS) is accountable for driving the safety and risk management activities for one or more assigned clinical development projects or marketed products to enable the safe and effective use of Alexions products by patients and healthcare providers. Lead safety activities for investigational products and/or marketed including identification and evaluation of safety signals and risk management to drive decision-making on risk/benefit evaluation. The Medical Director GPS will be supervised by Global Safety Program Lead.

You will be responsible for:

• Leading risk management evaluation and resolution for assigned products and projects.
• Own overall scientific and clinical safety content for the assigned asset(s) or indications.
• Implement and deliver high quality of the Safety & Strategy Management Team (SSaMT) and Safety Surveillance Team for assigned asset(s).
• Responsible for overall safety content for the product or indication(s) aligned to GPT strategy. Sets safety team goals aligned to TA and product strategy.
• For the assigned asset(s) responsible for safety TPP Safety Go/No Go criteria safety communication/messaging and the guidelines for toxicity management of the asset
• Responsible for safety contribution to study designs and study concept delivery within their assigned program
• Chairing and/or directing the Safety Management Team for the assigned project(s) or product(s) ensuring a safety and risk/benefit driven agenda from inception to closure
• Representing Alexion GPS at internal strategic and/or advisory/governance committees other project/product team(s) or subteam(s) as a key cross functional member and subject matter expert and/or act as an external technical resource at DSMB or Regulatory Authority meetings
• Detecting validating and managing pre-and/or post-approval safety signals through to resolution
• Evaluating aggregate safety data and providing contributions to core regulatory documents i.e. Periodic Safety Update Reports Drug Safety Update Reports Risk Management Plans and other routine and non-routine safety and risk/benefit evaluations for internal or regulatory purposes as required
• Identifying initiating and managing to completion necessary updates to the IB CCSI and/or local product information Medication Guide Patient Leaflet and other labeling documentation as necessary
• Leading all aspects of safety sections of documents and safety interactions with Regulatory authorities. This may include: authorship of safety summaries to support changes to the PI/SmPC significant contribution to MAAs and NDAs
• Delivers analyses of clinical safety data in a balanced and statistically robust manner to drive interpretations and develop novel proposals.
• Serves as a source of scientific and clinical safety knowledge for the Product Team in the analyses and interpretation of scientific and clinical safety data.
• This job description is not exhaustive and may include other job-related duties as assigned.

You will need to have:

• MD or equivalent degree or a life sciences/pharmacy/nursing degree and demonstrated Patient Safety and/or Clinical/ Drug Development experience
• Sound problem solving skills including the ability to make decisions by developing innovative options and/or multiple solutions to highly complex problems
• The ability to manage multiple overlapping complex tasks to conclusion sometimes to tight timelines for several projects and sub-projects including oversight of others working on those projects
• Knowledge and understanding of GPS deliverables standards and processes
• Knowledge and understanding of US and EU safety regulations pre- and post- marketing
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role employees must be able with or without an accommodation to: use a computer; engage in communications via phone video and electronic messaging; engage in problem solving and non-linear thought analysis and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

• 2-3 years safety and risk management experience in the pharmaceutical biotech or CRO industry
• Rare Ultra-Rare or Orphan Disease Area experience
• Strong verbal and written communication skills including making recommended courses of action to management
• Excellent independent judgment based on knowledge and expertise
• Strong personal time-management and project-management skills
• Proficiency in Microsoft Word PowerPoint and Excel

The annual base pay for this position ranges from $ 249827.20 - $374740.80 USD. Our positions offer eligibility for various incentivesan opportunity to receive short-term incentive bonuses equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs paid time off (i.e. vacation holiday and leaves) as well as health dental and vision coverage in accordance with the terms of the applicable plans.

When we put unexpected teams in the same room we ignite bold thinking with the power to encourage life-changing -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our outstanding and bold world!

Why AstraZeneca:

Join a company where groundbreaking science meets real-world urgency for patients with severe and rare conditions. You will work shoulder-to-shoulder with experts across fields using innovative tools and diverse perspectives to solve problems that matter. We combine the agility and curiosity of biotech with the scale stability and reach of a global leaderbacking bold ideas with the resources to deliver. We value kindness alongside ambition invest in your growth and empower you to make confident decisions that move therapies forward safely and faster for those who need them most.

Call to Action:

Step into a role where your safety leadership shapes medicines and changes livesbring your expertise set the standard and help us deliver better outcomes sooner!

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and furtherance of that mission we welcome and consider applications from all qualified candidates regardless of their protected characteristics. If you have a disability or special need that requires accommodation please complete the corresponding section in the application form.