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Senior Medical Director, Global Drug Safety

Alexion Pharmaceuticals

This is a Full-time position in Wilmington, DE posted December 29, 2021.

Some opportunities happen only once in a lifetime – like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star.

We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives.

We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.

This position can be based from any of the following Alexion locations; Boston, MA, New Haven, CT, or Wilmington, DE 

Position Summary

The Senior Medical Director provides global strategic and operational oversight of Alexion’s Safety Surveillance and Risk Management activities for assigned therapeutic area in fulfillment of global legislation and regulations.

The jobholder defines the Safety Surveillance and Risk Management strategy and ensures its execution through leadership of a team of Medical Safety Directors and Safety Surveillance Scientists.

This global team is accountable for the identification, analyses, assessment, communication, and risk management of safety issues arising for the assigned product portfolio across their entire lifecycles.

The jobholder provides medical and drug safety expertise to oversee and lead decision making based on complex risk/benefit evaluation, pharmacoepidemiologic or clinical trial data interpretation, risk assessment and risk mitigation.

In this capacity, the jobholder may represent the Global Drug Safety department as a subject matter expert on internal strategic or advisory committees.

The jobholder has significant impact on cross-functional goals, including collaborating with the Clinical & Medical organization to enhance the safe and effective use of Alexion products and with the Commercial Organization to increase the probability of regulatory success.

The Senior Medical Director reports to the Executive Medical Director, Global Drug Safety.

Job Duties & Responsibilities

Provides Global Drug Safety leadership and contributes to key Alexion governance processes.

Accountable for the following:

  • Leads a team of Medical Directors and Safety Surveillance Scientists, and is responsible for people management activities; coaches, counsels and develops direct reports
  • Represents Global Drug Safety at internal strategic and/or advisory/governance committees
  • Chairs or participates in internal Safety Review Boards where applicable
  • May represent Alexion or act as an external technical resource at DSMB or Regulatory Authority meetings, or at external conferences
  • Leads, provides input and oversight of the ongoing safety surveillance, benefit risk assessment and risk management activities for assigned Alexion product portfolio for entire lifecycle (pre and post approval).

    Accountable for the following:

  • Leads a team of Medical Directors, and Safety Surveillance Scientists in identifying, evaluating and facilitating resolution of safety signals, including effective communication of risk management plans
  • Provides medical and pharmacovigilance expertise to oversee and lead decision making based on complex risk/benefit evaluation, pharmacoepidemiologic or clinical trial data interpretation, risk assessment and risk mitigation
  • Partners with internal leaders within Global Drug Safety as well as other Alexion functions and affiliates to deliver integrated pharmacovigilance and risk management support to the Alexion business
  • Attends Product Safety Management Teams with Medical Directors on an ad hoc basis to support key decision-making, drive evidence–based conclusions and develop pivotal next steps
  • Personally assumes and oversees work carried out on products and/or issues under highest scrutiny from a patient safety or regulatory perspective
  • Ensures ongoing and adequate safety surveillance, and timely detection and communication of new safety issues by his/her team
  • Ensures timely and adequate generation of aggregate reports, regulatory responses, and risk management documentation by team, according to international requirements and internal standards.
  • Responsible for ensuring adequate definition and implementation of risk minimization activities for assigned product portfolio
  • Is responsible for people management activities; coaches, counsels and develops a proactive-solution oriented approach to safety signal detection, evaluation and resolution

Essential Qualifications

  • MD or equivalent degree required
  • 8 years extensive relevant pharmaceutical industry experience, in the safety and risk management area, including in signal detection, validation and management
  • Demonstrated competence as a results-driven leader to drive teams to foster a proactive solution oriented to safety signal detection, evaluation, and risk management
  • Thorough knowledge and understanding of PV deliverables, standards, and processes at a global level; including pre and post launch experience
  • Excellent interpersonal, analytical, managerial, and organizational skills
  • Strong verbal and written communication including making recommended courses of action to cross-functional senior leaders that impact the discipline, department/line, and influences their decisions
  • Ability to navigate across a matrixed environment and influence cross-functional senior leaders on decision-making (e.g.

    Clinical Development, Medical Affairs, Regulatory Affairs)

  • Ability to collaborate with internal and external leaders to ensure consistency of actions and decision-making with overall functional strategies
  • Sound judgment to filter information and weigh multiple factors to make decisions to ensure the safety of products for patients
  • Sound problem solving skills including the ability to make decisions by developing innovative options and/or multiple solutions to highly complex problems
  • Demonstrated ability to motivate, mentor, influence and collaborate with others in a complex global organizational matrix

Preferred Qualifications

  • Clinical experience, a few years in clinical medicine (post-training/residency)
  • Rare, Ultra-Rare or Orphan Disease Area experience
  • Excellent, independent judgment based on leading-edge knowledge and expertise
  • speaking skills, industry conference speaking experience and profile

*LI-MW1

Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines.

Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. 

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer.

We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness.

The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, parental status (including adoption or surrogacy), pregnancy (including childbirth, breastfeeding, or related medical conditions), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law.

Alexion provides reasonable accommodations to meet the needs of candidates and employees.

As a leading employer in our industry, Alexion offers a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families.

Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.

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