Global Development Associate Medical Director II

Job Description

Responsible for medical/clinical components of periodic reports such as Periodic Benefit Risk Evaluation Reports (PBRERs), Developmental Safety Update Reports (DSURs), and annual New Drug Application (NDA) reports, license renewals, labeling, and regulatory responses (in collaboration with other team members) under the direction of the Global Clinical Leader (GCL) or delegate Senior Medical Lead (SML) Participate and provide inputs in safety review meetings as required Work with international colleagues and external Alliance partners on development initiatives and regulatory issues Apply strategic intent of AstraZeneca when working with Alliance partners, Regulatory Authorities, payers, opinion leaders, prescribers, and consumers of AstraZeneca products Serve as a source of medical expertise for the Product Team Provide guidance for investigator-initiated trials in cooperation with regional marketing companies Act as Global Clinical Leader delegate on assigned tasks Accountable to GCL (or delegate) and Clinical leadership for identifying risks and proposing mitigation strategies to enable successful execution of License-to-Operate tactics Ensure consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations, and laws Accountable to GCL (or delegate) and Clinical leadership for identifying risks and proposing mitigation strategies to deliver successful Phase III or LCM studies Other Activities: Participate in external regulatory and non-regulatory meetings including those with consultants and other companies such as licensing partners Contribute to the advancement of methodology and process by generating new ideas and proposals for implementation Raise concerns/issues to senior management in a timely, open, and appropriate manner; ensure quality and integrity of issue/event being escalated Collaborate effectively in cross-functional and cross-cultural project teams and environments, and work with external providers Essential Skills/Experience: Graduate of a recognized school of medicine with an M.B.B.S./M.D. degree or equivalent At least 2 years of clinical experience post-registration 7+ years clinical research expertise in relevant therapy area or CRO experience High level of medical competence, with an ability to balance this with industry standards to achieve business goals Fluent in oral and written English Proven teamwork and collaboration skills Good presentation skills. Can communicate effectively with internal and external collaborators Desirable Skills/Experience: Able to work across TAs and Functions A demonstrated ability to understand epidemiological data Ability to review literature and identification of safety and efficacy data Benefit-risk assessment Specialty training in cardiology or endocrinology At AstraZeneca, we are driven by a shared purpose to push the boundaries of science to deliver life-changing medicines. Our collaborative culture fosters innovation and creativity, empowering you to make a real difference in patients lives. With access to cutting-edge technology and a diverse pipeline, youll have the opportunity to work on groundbreaking projects that address some of the most complex unmet medical needs