Medical Director, Global Patient Safety

Alexion • Boston, MA

3d • Onsite

About The Position

The Medical Director, Global Patient Safety (G P S) 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 will be responsible for 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. Accountability/responsible for the following: Responsible for the overall scientific and clinical safety content for the assigned asset(s) or indications. Responsible for the implementation and the high quality delivery 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 G PS 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. 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. Overseeing 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 other job-related duties as assigned.

Requirements

• 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 G P S deliverables, standards and processes
• Knowledge and understanding of US and EU safety regulations pre- and post- marketing

Nice To Haves

• 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 communication skills including making recommended courses of action to management and/or senior leaders that impact the discipline, department or line, and influences their decisions
• Excellent, independent judgment based on knowledge and expertise
• Strong personal time-management and project-management skills
• Mastery of Microsoft Word, PowerPoint and Excel

Responsibilities

• Lead ing risk management evaluation and resolution for assigned products and projects.
• Responsible for the overall scientific and clinical safety content for the assigned asset(s) or indications.
• Responsible for the implementation and the high quality delivery 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 G PS 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.
• 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.
• Overseeing safety sections of documents and safety interactions with Regulatory authorities.
• 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.

Benefits

• Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior