This is what you will doThis role is usually assigned to 2 or more programs, providing guidance and mentoring to the MediClinical Development Scientists on the teams, serving on cross asset strategic teams (e.g., disease strategy team) and providing input to strategic decisions at the TA Strategy Team and Global Medicine Team meetings.
This is a therapeutic area specialized role and is specifically designated to provide medical leadership and input to Program Teams during the early to late stage of drug development (i.e., transitioning molecule through IND/CTA and FirstinHuman study stage to ProofofConcept and EndofPhase2 stage and beyond).
You will be responsible for! Representing Clinical Development on the Global Program Team (GPT) and Global Medicine Team in presentations at management and review committees (e.g., Clinical Document Review Committee, Development and Commercial Steering Committee).
Fostering development of Medical Directors and CDS and/or fellows.
Leading 2 programs and the preparation and execution of a clinical development strategy and related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents.
Providing scientific and medical input (consultative services) to other R&D, commercial, translational, medicine and business development functions and leads or oversees clinical activities to support due diligences.
Working internally with other members of the CDP to drive program strategy and CDPs. Coordinate communications and planning between medical functions (Global Medical Affairs, Safety, Clinical Operations, Biostatistics, Epidemiology and Medical Science) as it relates to clinical development study design, execution and interpretation of results. Serves as the medical authority on the global product labeling team.
Driving awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review.
Working as part of a cross-functional team with colleagues from biostatistics, data management, clinical pharmacology, commercial, regulatory and project management.
You will need to have!M.D. or equivalent
7+ years of experience in clinical development; clinical research, global regulatory, and product development expertise
We would prefer you to have!PhD in related subject area
5+ years of Industry experience
Transplant experience
Experience preparing documents and attending regulatory meetings with FDA and other regulatory agencies
Experience designing and completing multinational clinical trials
History of leading cross-functional teams to define clinical strategy and clinical study design
Experience supporting business development activities
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 nonlinear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
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 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 gives 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. Vaccination status 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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