Global Development Associate Medical Director I/II

Job Title: Global Development Associate Medical Director I/II

Career Level: E

This incumbent will oversee the management of the Established Brands Oncology portfolio.

Introduction to role

Are you ready to make a difference in the world of Oncology? As a Global Development Associate Medical Director, you will provide medical input to all aspects of product maintenance and license-to-operate activities. This includes periodic reporting, license renewals, and responses to external requests, including regulatory requests. You will operate according to the highest ethical standards in compliance with internal SOPs, local regulations, laws, and adherence to Good Clinical Practice and regulatory requirements.

Accountabilities

• Responsible for Medical/Late Development Oncology components (benefit-risk evaluation) of periodic reports such as Periodic Safety Update Reports (PSURs)/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 Head (GCH) or delegate Global Clinical Program Lead (GCPL)/Senior Medical Lead (SML)
• Participate and provide inputs in safety review meetings as required
• Work with international colleagues and external Alliance partners on regulatory requests/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 by providing clinical and scientific expertise/inputs into protocols, clinical study reports
• Act as GCH delegate on assigned tasks
• Responsible for the relevance and accuracy of clinical science underpinning LCM project-related clinical development activities in support of regulatory approval and market access globally
• Identify risks and propose mitigation strategies to enable successful execution of License-to-Operate tactics or LCM studies (Life Cycle Management)
• Ensure consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations, and laws

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/post-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 drug development in relevant therapy area in Industry or academic experience or CRO experience required
• High level of medical competence, with an ability to balance this with industry standards to achieve business goals
• Possesses detailed knowledge of GCP and other regulations governing clinical research
• Ability to grow and maintain a high level of expertise in oncology therapeutic area
• Demonstrates solid understanding of methodology in the design, conduct, review and interpretation, and presentation of clinical research
• 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 Skills/Experience

• A demonstrated ability to understand epidemiological data
• Ability to review literature and identification of safety and efficacy data
• Benefit-risk assessment
• Specialty training in oncology
• 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

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.

Join the team at AstraZeneca that is committed to following the science. Driven by curiosity, passion, and determination, we are paving the way to change the practice of medicine in Oncology. With one of the broadest and deepest Oncology pipelines in the industry, there are many opportunities to work with new and novel drugs. We are a science-based enterprise united in our vision to eliminate cancer as a cause of death. Empowered by the business and each other, we embody courage and curiosity, taking smart risks, challenging the norm, and learning from failures.

Ready to make an impact? Apply now!

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.