JOB TITLE: GLOBAL DEVELOPMENT ASSOCIATE MEDICAL DIRECTOR II

CAREER LEVEL: E

ABOUT ASTRAZENECA AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world?s most serious disease. But we?re more than one of the world?s leading pharmaceutical companies. At AstraZeneca we?re dedicated to being a Great Place to Work.

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Provides medical input to all aspects of product maintenance/license- to- operate activities such as periodic reporting, license renewals and responses to external requests including regulatory requests. In addition, provide clinical support to product study teams as needed. Operating according to the highest ethical standards in compliance with internal SOPs, local regulations, laws and adherence to Good Clinical Practice and regulatory requirements

Typical accountabilities:

• Is 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, labelling and regulatory responses (in collaboration with other team members) under the direction of the Global Clinical Head (GCH) or delegate Global Clinical Program Lead (GCPL)
• Participate and provide inputs in safety review meetings as required
• Works with international colleagues and with external Alliance partners on development initiatives and regulatory issues
• Applies strategic intent of AstraZeneca when working with Alliance partners, Regulatory Authorities, payers, opinion leaders, prescribers and consumers of AstraZeneca products
• Able to serve as a source of medical expertise for the Product Team
• Able to serve as a source of medical input for design of clinical trials on drug projects
• Able to act as GCH delegate on assigned tasks.
• Is accountable to GCH (or delegate) and Clinical leadership for identifying risks and proposing mitigation strategies to enable a successful execution of License-to-Operate tactics, successful clinical trials or LCM studies (Life Cycle Management)
• Is accountable to GCH (or delegate) and Clinical leadership for identifying risks and proposing mitigation strategies to deliver successful clinical studies.
• Ensures consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations, and laws

Other Activities:

• Participates in external regulatory and non-regulatory meetings including those with consultants and other companies such as licensing partners.
• May contribute to the advancement of methodology and process by generating new ideas and proposals for implementation.
• Raises concerns/issues to senior management in a timely, open and appropriate manner; ensures quality and integrity of issue/event being escalated.
• Collaborates effectively in cross-functional and cross-cultural project teams and environments, and work with external providers.

Requirements ? Education and Experience Essential:

• 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
• 5 to 8 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
• Good knowledge of biostatistics, global regulatory environment and pharmacovigilance
• Fluent in oral and written English
• Proven teamwork and collaboration skills
• Good presentation skills. Can communicate effectively with internal and external collaborators
• Demonstrated leadership qualities with particular focus on collaborative working skills, trust and openness, irrespective of cultural setting
• Demonstrates AstraZeneca values and Behaviours
• Agile responsiveness to scientific data. Credible in scientific and commercial environments

Desirable:

• 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
• An understanding of pharmaceutical industry R&D, particularly of major clinical milestones and of the factors which influence Drug development.
• An understanding of the interplay between clinical, commercial objectives, drug safety and regulatory requirements

SO, WHAT?S NEXT? Are you already envisioning yourself joining our team? Good, because we?d love to hear from you! Click the link to apply, and we?ll be in touch as soon as we can. WHERE CAN I FIND OUT MORE? Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/ We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.