Medical Director, Global Patient Safety

This is what you will do:

The Medical Director, GlobalPatientSafety (GPS) is accountable for executing 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 Alexion’s products by patients and healthcare providers.The Medical Director willbe responsible forsafety activities for investigational products and/or marketed, includingidentification and evaluation of safety signals and risk management to drive decision-making on risk/benefit evaluation.The Medical DirectorGPSwill be supervised byGlobalSafety Program Lead.

You willbe responsible for:

Leadingrisk management evaluation and resolution for assigned products and projects.Accountability/responsiblefor the following:

• Responsiblefor the overall scientific and clinical safety content for the assigned asset(s) or indications. 

• Responsiblefor the implementation and thehigh qualitydelivery of the Safety & Strategy Management Team (SSaMT) and Safety Surveillance Team for assigned asset(s). 

• Responsible for overall safety content for the product orindication(s) alignedtoGPTstrategy. Sets safety team goals aligned to TA and product strategy. 

• For the assigned asset(s),responsiblefor safety TPP, Safety Go/No Go criteria, safety communication/messagingand the guidelines for toxicity management of the asset 

• Responsiblefor safety contribution to study designs and study concept delivery within their assigned program 

• Chairingand/or directingthe Safety Management Team for the assigned project(s) or product(s) ensuring a safety and risk/benefit driven agenda frominceptionto closure

• RepresentingAlexionGPSat internal strategic and/or advisory/governance committees,other project/product team(s) orsubteam(s) as a key cross functional member and subject matter expert,and/oract as an external technical resource at DSMB or Regulatory Authority meetings

• Detecting,validating,and managingpre-and/or post-approval safety signals through to resolution

• Evaluatingaggregate safety data and providingcontributions to core regulatory documentsi.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 asrequired

• Identifying,initiating,and managingto completion, necessary updates to the IB, CCSI and/or local product information, Medication Guide, Patient Leaflet, and other labeling documentation as necessary

• Overseeing safety sections of documents and safety interactions with Regulatory authorities. This mayinclude:authorship of safety summaries to support changes to the PI/SmPC, significant contribution to MAAs and NDAs

• Deliversanalysesof 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 theanalysesand interpretation of scientific and clinical safety data. 

• Thisjob description is not exhaustive and may include otherotherjob-related duties as assigned. 

You will need to have:

• MD or equivalent degreeoralife sciences/pharmacy/nursing degree,anddemonstratedPatient 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 tohighly complexproblems

• 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,standardsand processes

• Knowledge and understanding of US and EU safety regulations pre- and post- marketing

• The duties of this role aregenerally conductedin an office environment. As is typical of an office-based role, employees must be able, with or withoutan accommodationto: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 wouldpreferfor you to have:

• 2-3 years relevant safety and risk management experience in the pharmaceutical, biotech or CRO industry 

• Rare, Ultra-Rare or Orphan Disease Area experience

• Strong verbal and written communicationskillsincluding making recommended courses of action to management and/or senior leaders thatimpactthe discipline,departmentor line, and influences their decisions

• Excellent, independent judgment based on knowledge andexpertise

• Strong personal time-management and project-management skills

• Mastery of Microsoft Word,PowerPointand Excel