Global Safety Program Lead / Sr Medical Director

Global Safety Program Lead / Senior Medical Director

Join to apply for the Global Safety Program Lead / Senior Medical Director role at Alexion Pharmaceuticals, Inc.

Responsibilities

The Global Safety Program Lead, Senior Director is accountable to the Global Safety Head for the safety strategy, delivery, and oversight of the assigned asset(s). The professional will work with safety physicians and scientists responsible for the development, implementation, and application of safety strategy at asset and study level. Acts strategically to generate opportunity and value for the asset or indication to optimize benefit risk and maintain a competitive advantage. Line manages a team of safety physicians and / or scientists and may deputise for the Global Safety Head.

• Accountable for the overall scientific and clinical safety content for the assigned asset(s) or indications.
• Accountable 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), accountable for safety TPP, Safety Go / No Go criteria, safety communication / messaging and the guidelines for toxicity management of the asset.
• Is accountable for project representation for Global Patient Safety at governance and other forums where safety is involved, eg DRC, eCRC, SARB, FSIRB, and DSMB / DMC, Affairs Review Committees (MARC), product teams such CPT and GPT and Advisory Board meetings in partnership with GSH.
• Accountable for the quality of key safety deliverables e.g., Risk Management Plans (RMPs) and Periodic Safety Reports (PSRs), compliance and adherence to PV regulations of the assigned asset(s).
• Leads response to complex technical issues for specific safety aspects for the assigned asset(s).
• Is accountable for safety contribution to study designs and study concept delivery within their assigned program.
• Through integrated understanding of the product strategy, provides strategic safety knowledge and support to the safety medical directors and scientists through initiation, execution, and completion of the clinical programs for the assigned asset(s).
• Leads the safety physicians and scientists to support the safety strategy and input into the program design, monitoring, and data interpretation from pre‑clinical and clinical studies, communication and post‑marketing surveillance, epidemiology, pre‑clinical and literature, epidemiology for each asset.
• Ensures that own work and work of team is compliant with Safety Health and Environment (SHE) standards and all other relevant internal and external regulations and standards.
• Represents the Company and accountable for the quality of safety delivery e.g., regulatory submissions, answers to Health Authority Queries, Ethic Committees, Marketing Companies, investigators / sites, and provides clarifications as well as solves safety issues in the study team.
• May be required to support in‑licensing opportunities.
• Promotes and enables cross‑functional, proactive and solutions‑orientated team actions and behaviours.
• Accountable for implementation of new processes, systems and learning, including new ways of working.
• Prioritizes risk mitigation strategies and effective trouble shooting.
• Line manages a team of safety physicians and / or scientists.

Scientific Clinical Safety Analytical Accountabilities

You Will Need To Have

We Would Prefer For You To Have

Annual base pay (or hourly rate of compensation) for this position ranges from $280,895 to $421,342.

Date Posted : 26-Nov-2025

Closing Date : 30-Jan-2026

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.

Seniority level : Director

Employment type : Full‑time

Job function : Health Care Provider

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