Job Title: Global Development Associate Medical Director II
Career Level - E
Introduction to role
The Global Development Associate Medical Director is an important part of the Clinical Project Team (CPT), and Global Study Team (GST) working cross functionally (in a matrix environment) with other CPT, GST and GPT members, Site Management & Monitoring (SMM), field-based liaisons, and site personnel. A Global Development Associate Medical Director and a Global Development Scientist may work collaboratively on the clinical work underpinning a product. Accountabilities include clinical support for the development and implementation of late phase AstraZeneca sponsored clinical program strategies, including providing clinical input into design & implementation of clinical trial(s), their delivery, clinical data review, interpretation of results, reporting successfully on time, and activities required for worldwide registration of the product (i.e. clinical input to (s)NDA/(s)BLA). The Global Development Associate Medical Director plays a critical role in the medical monitoring of a clinical study ensuring safety to patients. They share responsibility with Clinical Operations team members in the planning, execution and closure of a clinical study.
The Global Development Associate Medical Director is responsible for the ensuring the risk-benefit of a clinical study, ensuring that all clinical studies operate to the highest ethical and safety standards and in compliance FDA, EMEA, ICH and GCP guidelines as well as SOPs regarding safety.
The Global Development Associate Medical Director may contribute/assist with functional process improvement initiatives and provide contributions to cross asset, cross tumor working groups or cross Therapy Areas.
As a key member of the clinical team, this position demands strong collaborative communication skills, including the ability to engage with and influence a diverse range of stakeholders both within and external to AstraZeneca. The individual will operate according to the highest ethical standards in compliance with internal SOPs, local regulations, laws and adhere to Good Clinical Practice and regulatory requirements.
Supports in evaluating the risk-benefit of a clinical study, ensuring that all clinical studies operate to the highest ethical and safety standards and in compliance FDA, EMEA, ICH and GCP guidelines as well as SOPs regarding safety.
Work cross functionally within clinical product teams (CPT) to ensure the clinical strategy is translated into the development of the study concept document, study protocol and related documents (such as Global ICF, CRF, TFL shells, etc)
Supports drafting and review of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports and other Health Authority submissions.
Participates in the development of producing materials for investigator meetings (e.g., slides, booklets, and presentation materials), addressing questions regarding scientific and protocol procedures from other study team members and investigative sites.
Develop relationships with appropriate consultants and key external experts (KEE), study sites, and utilize these relationships to obtain feedback on protocol design, as well as study training, study execution, and interpretation of study results, and inform recruitment strategies.
Contributes to the development of medical oversight plan (MOP) and lead or contribute to the study-level medical monitoring activities accordingly, e.g, monitoring the scientific conduct of the study and safety and efficacy data review and cleaning.
Member of the GST representing Clinical Development.
Technical Skills
Drug Development/Clinical Development Planning: Demonstrates the ability to contribute to the planning, and timely organization of components of the clinical development plan and work with other functions to achieve successful study initiation and execution.
Ability to contribute to protocol design, writing and implementation to meet GCP, ICH and all AZ quality standards.
Demonstrates understanding of methodology in the design, conduct, review and interpretation, and presentation of clinical research.
Effectively organizes content and rationales in assigned sections of clinical reports or regulatory/EC/IRB documents(i.e. CTA, briefing book, BLA/NDA).
Contributes to the preparation and presentation of clinical data and/or selected training sessions to internal/external groups.
Required M.D or MD./Ph.D. degree or equivalent. Strong preference for individuals with clinical training in oncology
Industry or academic experience in drug development required.
Possesses detailed knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research.
Possesses general knowledge of 1) medical monitoring 2) Regulatory approval process in relevant countries; 3) pharmaceutical industry/R&D operations; 4) marketing and commercial fundamentals.
Ability to grow and maintain a high level of expertise in oncology therapeutic area
Key Relationships to reach solutions
Internal (to AZ or team)
Global Development Scientists
Director Clinical Development & Associate Director Clinical Development
Global Study Team and providers of services to the study team
Clinical Project Team / Global Product Team
Global Clinical Program Leaders
Global Clinical Heads
Medical Science Liaisons (MSLs)
Site Management & Monitoring
Patient Safety
Publications/Communication teams
Other functional leaders ( GPL, GPS, GRL, etc.)
External (to AZ)
External service providers
Investigators and site staff
Key External Experts
Ethic Committees/Institutional Review Boards
Regulatory Authorities
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.
Apply now to be part of our journey!
Date Posted
Closing Date
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.