Global Development Medical Director, Hematology Oncology

Role Overview

The Global Development 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. The role works collaboratively with the counterpart Global Development Scientist on the clinical aspects underpinning a product.

Accountabilities

• Provide clinical support for the development and implementation of early and/or late phase AstraZeneca sponsored clinical program strategies, including clinical input into design and implementation of clinical trials, their delivery, clinical data review, interpretation of results, reporting, and activities required for worldwide registration of the product (i.e. clinical input to (s)NDA/(s)BLA).
• Play a critical role in the medical monitoring of a clinical study ensuring safety to patients; share responsibility with Clinical Operations team members in the planning, execution and closure of a clinical study.
• Ensure the risk-benefit of a clinical study and that all clinical studies operate to the highest ethical and safety standards and in compliance with FDA, EMEA, ICH and GCP guidelines as well as AZ SOPs regarding safety.
• Work cross-functionally and lead all aspects of the design and implementation of clinical hemato-oncology projects as a leader of the Clinical Product Team (CPT) and member of the Clinical Sub-Team (CST).
• Ensure that the overall scientific and medical content of all clinical programs is scientifically and clinically rigorous.
• Significantly contribute to the development of program strategy for assigned compound(s)/programs and work with GPT/CPT members to develop a compelling business case for governance approval.
• Provide expert clinical input to influence study design via collaboration with primary investigators, key external experts (KEE), study sites, team members, and internal stakeholders.
• Participate or lead as needed the review and assessment of new opportunities and ESRs.
• Be accountable for the relevance and accuracy of clinical science underpinning clinical studies, for the clinical and scientific leadership and integrity of protocols and/or components of clinical plans, and for the delivery of final protocol and its governance approval.
• Provide expert input into or lead the development of the protocol and related documents and the development and delivery of the clinical study report.
• Take full responsibility for the planning, implementation and daily operation of assigned drug development projects in hemato-oncology.
• Support or lead interactions with global medical affairs, marketing companies, and commercial, in collaboration with GCH/GCPL to ensure cross-functional input into protocols.
• Be responsible for timely responses to investigational study sites for local ICF changes, protocol and EC/IRB questions/requests.
• Contribute to development and delivery of face-to-face or virtual investigator and monitor training.
• Support the development of clinical components of regulatory and EC/IRB submission documents for instances where marketing approval is warranted.
• Prepare clinical development plans that integrate pre-clinical and early clinical findings while working to ensure cross-functional alignment throughout the early phases of clinical development.
• Present and defend protocols and clinical development plans at internal governance forums.
• Serve as Medical Monitor, responsible for the safety monitoring of clinical trials, and as medical expert for Phase I/II or Phase III studies.
• Prepare various official and regulatory documents for Regulatory and other agencies, such as Dossiers, BLAs, INDs, Safety and Annual reports, and handle responses to regulatory agencies regarding complex clinical development issues.
• Implement clinical R&D policies, SOPs and related directives.
• Contribute and support Department/Clinical initiatives to improve the quality and content of all clinical programs as well as cross-functional/organization processes designed to effectively deliver the R&D portfolio.

Minimum Qualifications

• MD or international equivalent is required.
• Minimum of 2 years of relevant experience.
• Medical hemato-oncology clinical training is required.
• Board Certification is preferred.
• 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 process in relevant countries; pharmaceutical industry/R&D operations; and marketing and commercial fundamentals.
• Good understanding of clinical trials methodology.
• Strong communication and presentation skills to clearly communicate scientific concepts/data to leadership committees both internally and externally.