Global Development Senior Medical Director, Hematology Oncology

Accountabilities

• Clinical support for the development and implementation of early and/or late phase AstraZeneca sponsored clinical program strategies, including scientific input into design & implementation of clinical trials, their delivery, clinical data review, interpretation of results, reporting on time, and activities required for worldwide registration of the product (i.e. clinical input to (s)NDA/(s)BLA).
• 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.
• May provide expert input or lead functional process improvement initiatives and provide contributions to cross-asset, cross-indication working groups depending on the level of experience.
• Operate according to the highest ethical standards in compliance with internal SOPs, local regulations, laws and adhere to Good Clinical Practice and regulatory requirements.
• Depending upon experience level, mentor the development of less experienced members of the clinical team, and may involve direct line management of other physicians or scientists.
• Responsible for 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 AZ SOPs regarding safety.
• Work cross-functionally and lead all aspects of the design and implementation of clinical hemato-oncology projects, as leader of our 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.
• Significant contributor 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 the study design via collaboration with primary investigators, key external experts (KEE), study sites, team members, and internal stakeholders, such that it reflects clinical practice, evolving landscape, regulatory and reimbursement requirements, and meets the strategic program objectives.
• Participate or lead as needed the review and assessment of new opportunities and ESRs.
• Accountable for the relevance and accuracy of clinical science underpinning of clinical study based on detailed scientific review and consultation, 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.
• Provides expert input into/lead the development of the protocol and related documents and the development and delivery of the clinical study report.
• Full responsibility for the planning, implementation and daily operation of assigned drug development projects in hemato-oncology.
• Supports or leads interactions with global medical affairs, marketing companies, commercial, in collaboration with GCH/GCPL to ensure cross functional input into protocols.
• Responsible for timely responses to investigational study sites for local ICF changes, protocol & 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 on an ongoing basis 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, innovating the process from protocol development through individual study report and coordinated regulatory documentation.
• Prepare various official and regulatory documents for Regulatory and other agencies, such as Dossiers, BLAs, INDs, Safety and Annual reports, handling of responses to regulatory agencies regarding questions about complex clinical development issues (e.g., safety or efficacy).
• Implement clinical R&D policies, SOPs and related directives.
• Review potential in-licensing candidates and present recommendations to Senior Management groups.
• Support any needed due diligence and prepare/present medically sound strategy and plans associated with advanced opportunities.
• Contribute and support Department/Clinical initiatives to improve the quality and content of all clinical programs as well as the cross functional/organization processes designed to effectively deliver our R&D portfolio.
• Serve as mentor of less experienced staff that may include physicians or scientists.