Medical Director, Clinical Development Hematology
Alexion Pharmaceuticals, Inc.About the role
This is what you will do:
The Medical Director, Clinical Development, may lead or support the clinical subteam and the global program team to construct global clinical development plans and contribute to the development of asset level and therapeutic area strategies. This role is part of the Cell Therapy team and reports to the Senior Medical Director, Hematology.
You will be responsible for:
The design and execution of multiple clinical studies or clinical programs
Represent Clinical Development on the Global Program Team (GPT) and in presentations at management and review committees (e.g., Clinical Document Review Committee, Development and Commercial Steering Committee)
Work with one or more clinical study teams in the preparation of clinical study related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents
Select appropriate advisory board participants and guide the team in preparation for meetings
Critically evaluate available information about diseases of interest to the therapeutic area and the competitive landscape and synthesize information succinctly to support dissemination and incorporation into clinical development programs, asset plans and therapeutic area strategy
You will need to have:
MD, preferably Hematologist.
3+ years of clinical experience preferably within industry and/or Hematology.
Experience as a medical monitor for clinical trials
Publication in peer reviewed journals
The duties of this role are generally conducted in an office environment. As is typical of an office based role, employees must, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; problem resolution; engage in nonlinear thought, analysis, and dialogue; collaborate; maintain general availability during standard business hours
We would prefer for you to have:
Board Certification
Knowledge of the assigned therapy area with the capability to interpret, discuss and represent trial or program level data.
5+ years of industry experience in clinical development
Experience for medical responsibilities on a cross-functional team
Basic statistical knowledge
Understanding of general (and specific) therapeutic principles
Experience designing industry sponsored clinical trials
Broad experience in the principles of clinical trial methodology, statistics, data analysis and interpretation
Experience authoring study essential documents, Clinical Study Reports, and regulatory documents
Working at Alexion
We’re inspired to think differently, to create better outcomes. By creating an unparalleled employee experience, our organization is equipped to adapt and enrich employees with a productive, engaging, and enjoyable work experience, while accelerating world-class leadership and innovation capabilities that can deliver on our mission. Each of us is accountable for delivering innovative medicines and supportive technology with integrity so we can truly understand and better the lives of people affected by rare diseases. Together, we can transform lives every day The Highest Standards By operating with the highest standards of ethics and integrity, we aspire to live up to the expectations of patients, physicians, and ourselves, and to earn trust in our communities. Diversity We encourage diversity of backgrounds and ideas. We genuinely care for and respect each other, working together as a high-performing team to deliver extraordinary results while embracing different perspectives. Dedication The dedication and passion of our employees enable us to stay focused on what matters most. We push ourselves to achieve the highest level of medical innovation, and to redefine what it means to live with a rare disease. In-Office Hybrid This role has an expectation of working in the office a minimum of 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. Inperson 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 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 perspe
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