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 Directors and Safety 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, pharmacoepidemiological or clinical trial data interpretation, risk assessment and risk mitigation. In this capacity, the jobholder may represent the Global Patient 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 Patient Safety.
You will be responsible for:
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 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, pharmacoepidemiological or clinical trial data interpretation, risk assessment and risk mitigation
Partners with internal leaders within Global Patient Safety as well as other Alexion functions and affiliates to deliver integrated pharmacovigilance and risk management support to the Alexion business
Leads Product Safety Management Teams with Medical Directors to support key decision-making, drive evidence-based conclusions and develop pivotal next steps
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
You will need to have:
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 GPS deliverables, standards and processes
Knowledge and understanding of US and EU safety regulations pre- and post- marketing
The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
We would prefer for you to have:
5-7 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
Expectation of working in the office 3 days a week: When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
