Global Development Associate Medical Director

About the Company

Responsibilities

• ● o shape protocols, engage investigators and external experts, and translate emerging data into decisive actions that keep studies on track and patients safe. You will also have the opportunity to lead process improvements and contribute to cross-asset, cross-indication initiatives-broadening your impact as our oncology portfolio advances across multiple indications and stages. Your work will directly influence how we identify patients earlier, execute trials faster, and bring transformative therapies to those who need them most.
• ● 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.