Job Title: Senior Medical Director, Patient Safety
Overview of Role
The Senior Medical Director for Patient Safety at Alexion provides global strategic and operational leadership in Safety Surveillance and Risk Management activities for an assigned therapeutic area. You will lead a team of Medical Directors and Safety Scientists to ensure the identification, assessment, communication, and management of safety risks for the product portfolio throughout its lifecycle. This role requires balancing patient safety with business goals, applying expertise in benefit-risk evaluation, clinical trial data interpretation, and risk mitigation strategies.
Reporting to the Executive Medical Director, Global Patient Safety, you will collaborate across functions to advance regulatory success, improve patient safety, and support the effective use of Alexion’s innovative therapies.
Key Responsibilities
Safety Oversight and Risk Management
Oversee safety surveillance, benefit-risk assessments, and risk management activities for the entire lifecycle of assigned products (pre- and post-approval).
Lead a team in identifying, evaluating, and resolving safety signals, and develop effective communication of risk management strategies.
Provide medical and pharmacovigilance expertise to guide complex decision-making processes.
Partner with internal leaders to deliver integrated safety support across Alexion’s business units and affiliates.
Lead Product Safety Management Teams to drive evidence-based conclusions and recommend critical next steps.
Oversee safety activities for products under high regulatory or patient safety scrutiny.
Safety Surveillance and Documentation
Ensure timely detection, evaluation, and communication of new safety issues.
Oversee the generation of aggregate safety reports, regulatory responses, and risk management documentation in compliance with global standards.
Define and implement risk minimization strategies for assigned products.
Collaboration and Leadership
Work closely with Global Patient Safety, Clinical & Medical, and Commercial organizations to align safety strategies with business goals.
Represent Global Patient Safety as a subject matter expert on strategic or advisory committees.
Manage and mentor a high-performing team of Medical Directors and Safety Scientists.
Qualifications and Skills
Essential
Medical degree (MD or equivalent) or life sciences/pharmacy/nursing degree with substantial Patient Safety or Clinical/Drug Development experience.
Proficient in problem-solving and decision-making for highly complex scenarios.
Ability to manage multiple projects and teams under tight timelines.
In-depth knowledge of GPS deliverables, standards, and processes.
Thorough understanding of US and EU safety regulations for pre- and post-marketing.
Preferred
5–7 years of relevant experience in safety and risk management within the pharmaceutical, biotech, or CRO industry.
Experience with rare, ultra-rare, or orphan diseases.
Strong communication skills with the ability to influence senior leadership decisions.
Proven track record in time and project management.
Mastery of Microsoft Office Suite (Word, PowerPoint, Excel).
Why Join Alexion?
At Alexion, a part of AstraZeneca, you will contribute to groundbreaking work in rare and ultra-rare diseases. We foster an environment that values collaboration, diversity, and innovation. Working in-person at least three days a week promotes connectivity, agility, and bold thinking while respecting individual flexibility.
Join us in our mission to improve patient outcomes and redefine the possibilities of science.
How to Apply
Are you ready to take the next step in your career and make a meaningful impact on patients’ lives? Apply now to join our dynamic and ambitious team.
Alexion is an equal opportunity employer committed to diversity, inclusion, and compliance with all applicable laws regarding non-discrimination and employment.
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