Senior Medical Director, Global Drug Safety
Boston, MA 
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Job Description

This is what you will do:

The Senior Medical Director provides global strategic and operational oversight of Alexion's Safety Surveillance and Risk Management activities for the assigned therapeutic areas in fulfillment of global legislation and regulations. The jobholder defines the Safety Surveillance and Risk Management strategy and ensures its execution through the leadership of a team of Medical Safety Directors and Safety Surveillance Scientists. This global team is accountable for the identification, analysis, 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 the complex risk/benefit evaluation, pharmacoepidemiological 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 a 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.

You will be responsible for:

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 provide input and oversight of the ongoing safety surveillance, benefit-risk assessment, and risk management activities for the assigned Alexion product portfolio for the 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 the resolution of safety signals, including effective communication of risk management plans
  • Provides medical and pharmacovigilance expertise to oversee and lead decision making based on the complex risk/benefit evaluation, pharmacoepidemiological 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 the 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

You will need to have:

  • MD or equivalent degree required
  • 8 years of 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 or 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 in order 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
  • This position can be based in Blue Bell, PA, San Francisco, CA, Boston, MA, or remote/virtual.

We would prefer for you to have:

  • 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
  • Excellent speaking skills, industry conference speaking experience, and profile

*LISM-1

,

Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.

Alexionis 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. As a leader in rare diseases for more than 25 years,Alexionhas developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), as well as the first and only approved complement inhibitor to treat anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD).Alexionalso has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D) as well as the first and only approved Factor Xa inhibitor reversal agent. In addition, the company is developing several mid-to-late-stage therapies, including a copper-binding agent for Wilson disease, an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases and an oral Factor D inhibitor as well as several early-stage therapies, including one for light chain (AL) amyloidosis, a second oral Factor D inhibitor and a third complement inhibitor.Alexionfocuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, metabolic disorders and cardiology. Headquartered inBoston, Massachusetts,Alexionhas offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: .

As a leading employer in our industry, Alexion is proud to offer 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.


Portola Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any characteristic protected by law.


 

Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Experience
8+ years
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