Global Development Associate Medical Director

Introduction to role

The Global Development Associate Medical Director plays a pivotal role in the medical monitoring of clinical studies, ensuring patient safety. Collaborating closely with the Clinical Operations team, you will be involved in the planning, execution, and closure of clinical studies. Depending on your experience, you may also lead functional process improvement initiatives and contribute to cross-asset, cross-indication working groups. Are you ready to make a difference in hemato-oncology?

Accountabilities

• Responsible for ensuring the risk-benefit of a clinical study, maintaining the highest ethical and safety standards in compliance with FDA, EMEA, ICH, and GCP guidelines as well as AZ SOPs regarding safety.

• Work cross-functionally in the design and implementation of clinical hemato-oncology projects as a member of the Clinical Sub-Team (CST), ensuring scientific and clinical rigor.

• Contribute to the development of program strategy for assigned compounds/programs and collaborate with team members to develop compelling business cases for governance approval.

• Provide clinical input to influence study design through collaboration with primary investigators, key external experts (KEE), study sites, team members, and internal stakeholders.

• Participate or lead the review and assessment of new opportunities and ESRs as needed.

• Support interactions with global medical affairs, marketing companies, and commercial teams to ensure cross-functional input into protocols.

• Respond timely to investigational study sites for local ICF changes, protocol & EC/IRB questions/requests. Contribute to investigator and monitor training.

• Support the development of clinical components of regulatory and EC/IRB submission documents for marketing approval.

• Prepare clinical development plans integrating pre-clinical and early clinical findings while ensuring cross-functional alignment throughout early clinical development phases.

• Present and defend protocols and clinical development plans at internal governance forums.

• Serve as Medical Monitor, responsible for safety monitoring of clinical trials and as a medical expert for Phase I/II or Phase III studies.

• Prepare various official and regulatory documents for agencies such as Dossiers, BLAs, INDs, Safety and Annual reports.

• Implement clinical R&D policies, SOPs, and related directives.

• Contribute to Department/Clinical initiatives to improve the quality and content of all clinical programs.

Essential Skills/Experience

• MD or international equivalent is required

• Medical oncology clinical training is required

Desirable Skills/Experience

• Clinical or research experience (in an academic, pharmaceutical or CRO environment) related to the design and/or conduct of clinical studies in oncology and/or malignant hematology is preferred

• Possesses general knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research

• Possesses general knowledge of medical monitoring, regulatory approval processes in relevant countries, pharmaceutical industry/R&D operations, marketing, and commercial fundamentals

• Good understanding of clinical trials methodology

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.

At AstraZeneca, we push the boundaries of science to change the practice of medicine and transform patients' lives. Our pioneering spirit drives us to make bold moves that truly improve patient outcomes. With one of the broadest and deepest Oncology pipelines in the industry, you'll have many opportunities to work with new and novel drugs. We foster a collaborative environment where diverse knowledge from across the business and external partners comes together to tackle the toughest medical challenges. Empowered by our collective courage and curiosity, we take smart risks, challenge norms, and learn from failures. Join us at the forefront of applying science to studies using innovative approaches to create new possibilities.

Ready to make a meaningful 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 authorisation and employment eligibility verification requirements.