21 sep
|
AstraZeneca
|
Barcelona
21 sep
AstraZeneca
Barcelona
Overview In this role you will lead medical input across hemato-oncology clinical programs, ensuring scientific rigor and patient safety. You will collaborate with cross-functional teams to design, implement, and monitor AstraZeneca-sponsored studies from early through late phases. You will contribute to regulatory submissions and governance processes, and serve as Medical Monitor for trials. You will drive safety oversight and medical strategy, shaping programs that align with the company's mission to deliver life-changing medicines.
Responsabilidades Lead design and implementation of clinical hemato-oncology projects within CPT/CST
Provide clinical input to trial design, execution, data review and interpretation
Ensure safety monitoring and ethical/regulatory compliance across studies
Collaborate with external investigators, KEEs, sites and internal stakeholders to reflect clinical practice and regulatory requirements
Support regulatory submissions (INDs/BLAs, safety reports) and EC/IRB interactions
Develop clinical development plans integrating pre-clinical and early findings
Present protocols and plans at governance meetings and obtain approvals
Lead or contribute to cross-asset and cross-indication working groups
Manage day-to-day operations of assigned drug development projects in hemato-oncology
Serve as Medical Monitor for Phase I–III studies and influence study governance
Requisitos principales MD or international equivalent
Minimum 2 years of relevant experience
Medical hematology-oncology clinical training
Board Certification preferred
Experience with design/conduct of oncology/malignant hematology studies in academia, pharma or CRO
Knowledge of GCP and regulatory frameworks
Understanding of clinical trials methodology
Strong communication and presentation skills for leadership forums
strong communication & presentation skills
collaborative mindset
influencing and stakeholder engagement
Good Clinical Practice (GCP) knowledge
regulatory submission experien
📌 Therapy Development Manager (Barcelona)
🏢 AstraZeneca
📍 Barcelona