Global Development Medical Director

Job Title: Global Development Medical Director

Career Level - F

Introduction to role

Are you ready to push the boundaries of science and transform the lives of patients living with cardiovascular diseases? As a Global Development Medical Director , you will be responsible for providing 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. Additionally, you will deliver Phase III or LCM project-related clinical development activities to support regulatory approval and market access globally. 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/Global Medicines Development (GMed) components of periodic reports such as Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs) 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)

• 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 mentorship for investigator-initiated trials in agreement with regional marketing companies

• Act as Global Clinical Leader delegate on assigned tasks

• Accountable to GCH (or delegate) and late CVRM 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 GCH (or delegate) and late CVRM leadership for identifying risks and proposing mitigation strategies to deliver Phase III or LCM studies

Essential Skills/Experience

• Graduate of a recognized school of medicine with an M.B.B.S. or M.D. degree or equivalent scientist degree

• Proficient in oral and written English

• 3-5 years clinical research expertise in relevant therapy area or CRO experience.

• Good knowledge of biostatistics, global regulatory environment, and pharmacovigilance

• Confirmed partnership and collaboration skills

• Good presentation skills

• Can communicate reliably with internal and external collaborators

• Validated leadership skills with a particular focus on collaborative working skills, trust, and willingness, irrespective of cultural setting

• Demonstrates AstraZeneca values and Behaviours

• Agile responsiveness to data. Credible in scientific and commercial environments

Desirable Skills/Experience

• PhD in scientific Field

• Education in Pharmaceutical Medicine

• Specialty training in cardiology or endocrinology is helpful, though candidates with validated experience in other relevant areas may be considered for the position.

• Experience from different organizations

• An understanding of pharmaceutical industry R&D, particularly of major clinical turning points and the factors which influence drug development.

• An understanding of the interplay between, objectives, drug safety, and regulatory requirements

When we put unexpected teams in the same room, we fuel daring thinking with the power to encourage 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 outstanding and adventurous world.

At AstraZeneca, we are empowered to act fast on smart risks. We keep ahead in the fast-paced Oncology field by prioritizing and making adventurous moves. This empowers us to be adventurous decision-makers who speak up and constructively challenge. We always follow evidence to act on smart risks. With one of the broadest and deepest Oncology pipelines in the industry, there are many opportunities to work with new and novel drugs and help discover what's next.

Ready to make a difference? Apply now!